Category of

Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
1 Air Handling System 1) Aseptic filling area N/A
2) Sterilized components unloading area for aseptic
2 Air Handling System filling. N/A
3) Batch manufacturing area for aseptic filling
3 Air Handling System preparations. N/A
4 Air Handling System 4) Component washing and preparation area. N/A
5 Air Handling System 5) Change rooms to enter into Critical area.
Give the Background Grade of air for following
6 Air Handling System critical areas:
Specify the air classification in final change room to
7 Air Handling System enter A/B area. N/A
Specify the air velocity maintained in Grade A
8 Air Handling System Laminar Air Flow stations N/A
Specify the differential pressure between areas of
9 Air Handling System different environmental standards. C
Specify the number of air changes in Grade A/B and
10 Air Handling System Grade C areas. Pc only grad c
Specify the procedure followed for medial fill and
11 Air Handling System the acceptance criteria. N/A

Specify the recovery time of B & C zone from the

time of personnel leaving the room after completion
12 Air Handling System of operations and verify the records in this regard. N/A
Specify the steps taken in air handling system to
achieve the Grade A, B, C and D of air as per
13 Air Handling System designated classified areas. N/A
Specify type of manometer installed for
measurement and verification of Air Pressure
14 Air Handling System Differential. Magnehelic & digital Manometer

1

INSPECTION SECTION NAME
15 Air Handling System
16 Air Handling System
17 Air Handling System
18 Air Handling System
19 Air Handling System (HVAC)
20 Air Handling System (HVAC)
21 Air Handling System (HVAC)
22 Air Handling System (HVAC)
23 Air Handling System (HVAC)
24 Air Handling System (HVAC)
25 Air Handling System (HVAC)
26 Air Handling System (HVAC)
27 Air Handling System (HVAC)
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify whether filling operations are challenged
initially and there after periodically by simulation
trials including sterile media fill. N/A
Specify whether the Air Handling Units for sterile
product manufacturing area are separated from
those for other areas N/A
Whether simulation tests are repeated at defined
intervals and after any significant modification to
HVAC system, equipment or process. N/A
Whether the medial fill trial is based on worst case
situation taking into consideration all interventions,
activities occurring during normal activity as well as
worst case. N/A
1) Schematic drawings detailing the filters and their
specifications N/A
2) Number of air changes per hour N/A
3) pressure gradients N/A
a) The absence of direct venting of air to the
outside. N/A
Are the returns risers cleaned during Product
Change Over? N/A
b) Whether the facility is maintained at a negative
air pressure to the environment. N/A
c) The precaution taken to prevent the infiltration
into the core areas. N/A
d) Whether appropriate air pressure alarm systems
as well as alert and action limit is provided. N/A
e) The type of HEPA filters used in the HVAC system N/A
2

INSPECTION SECTION NAME
28 Air Handling System (HVAC)
29 Air Handling System (HVAC)
30 Air Handling System (HVAC)
31 Air Handling System (HVAC)
32 Air Handling System (HVAC)
33 Air Handling System (HVAC)
34 Air Handling System (HVAC)
35 Air Handling System (HVAC)
36 Air Handling System (HVAC)
37 Air Handling System (HVAC)
38 Air Handling System (HVAC)
39 Air Handling System (HVAC)
40 Air Handling System (HVAC)
41 Air Handling System (HVAC)
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
f) Whether the change rooms are supplied with N/A
g) The measures taken to prevent air flow from the
primary packing area to the secondary packing area.
Please specify whether following parameters are
qualified: (IQ,OQ,PQ) N/A
same quality of air as supplied to the working area. C
Specify the emergency power systems in case of
power failure. C stan by generators
Specify the no. of Air Change maintained in various
core areas. C
Specify the pressure balancing to segregate
different areas. C
Specify the Terminal Air Filter of various core areas. C H13,14
Specify what precaution has been taken during filter
change of AHUs. C sop number
Specify whether recirculated air is used. If yes,
specify the proportion of fresh air supplied. C 20-25%fresh air mixup
Specify whether the facilities and premises have
following basic air-handling characteristics:
Specify whether total No. of AHUs used to cover the
whole production Area is commensurate with the
requirements C 23 Ahu,s
Verify if the AHUs / HVAC systems have been shut
down. If yes the reasons there of such as cleaning &
maintenance & the procedures for re- initiation / re-
start of the systems C
Verify the SOPs for AHUs operation and cleaning. C
3

INSPECTION SECTION NAME
42 Air Handling System (HVAC)
43 Air Handling System (HVAC)
44 Air Handling System (HVAC)
45 Air Handling System (HVAC)
46 Air Handling System (HVAC)
47 Air Handling System (HVAC)
48 Air Handling System (HVAC)
49 Air Handling System (HVAC)
50 Air Handling System (HVAC)
51 Air Handling System (HVAC)
52 Air Handling System (HVAC)
53 Air Handling System (HVAC)
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether all exhaust points outside the building are
located as far as possible from air entry points, exit
points and at a high level, to minimize the possibility
of re-entrainment of exhaust air. C
Whether all exhaust systems from the facility,
including dust extraction systems, vacuum system
exhaust, fluid bed drier exhaust, coating pan
exhaust, etc., are passed through safe change filter
housings and wet scrubber before being exhausted
to the atmosphere. C
Whether HVAC system description includes: N/A
Whether records for safe disposal of all
contaminated filters and dust are maintained.
Whether risk assessment study has been carried out
in case of return air/ recirculated air system. Verify
the records thereof. NC
Whether the dust collectors are located in a room DC are located out
maintained at a negative pressure. N/A side in tech area
Whether the filters cleaning facility is maintained at
negative pressure. C
Whether the return air ducts are checked
periodically for dust accumulation.
— microbiological air and surface counts where
appropriate C
— operation of de-dusting C
— relative humidity C
— return air or exhaust air quantities C
4
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

54 Air Handling System (HVAC) — room air change rates C

55 Air Handling System (HVAC) — room airflow patterns C

56 Air Handling System (HVAC) — room clean-up rates C

57 Air Handling System (HVAC) — room particle counts C

58 Air Handling System (HVAC) — room pressures (pressure differentials) C

59 Air Handling System (HVAC) — supply air quantities for all diffusers C

60 Air Handling System (HVAC) — temperature C

61 Air Handling System (HVAC) — unidirectional flow velocities N/A

62 Air Handling System (HVAC) — warning/alarm systems C

63 Air Handling System (HVAC) —filter penetration tests (HEPA) C

Analytical Method Validation Specify whether following Characteristics are

64 (AMV):- considered during validation of analytical methods:
Analytical Method Validation
65 (AMV):- — Accuracy
Analytical Method Validation
66 (AMV):- — Detection Limit
Analytical Method Validation
67 (AMV):- — Linearity

5
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Analytical Method Validation
68 (AMV):- — Precision
Analytical Method Validation
69 (AMV):- — Quantification Limit
Analytical Method Validation
70 (AMV):- — Range
Analytical Method Validation
71 (AMV):- — Robustness.
Analytical Method Validation
72 (AMV):- — Specificity
Analytical Method Validation
73 (AMV):- —Solution Stability/Filter Study
Are there general change rooms in plant? specify
number of washing station & toilets provided for
74 Ancillary Areas number of users.
Is there in-house general laundry for garment
washing / cleaning? If not how garment washing is
75 Ancillary Areas carried out and monitored.
Specify whether primary clean garments are
provided for each personnel entering the factory
76 Ancillary Areas premises.
Whether change room facilities separated for both
77 Ancillary Areas sexes.
Whether maintenance workshop is separated and
78 Ancillary Areas away from production.

Witness the position of rest and refreshment rooms

and mention whether they are separated and not
leading directly to the manufacturing and
warehouse areas. Please also verify the adequacy of
79 Ancillary Areas rest rooms and cleanliness.

6
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Annual Product Quality Review Specify Whether Annual Product Quality review is
80 (APQR):- carried out for each product
Annual Product Quality Review Specify whether following criteria are considered
81 (APQR):- for review:
Annual Product Quality Review Verify whether Cp and CpK values are calculated
82 (APQR):- and what is the acceptance criteria fixed.
Annual Product Quality Review
83 (APQR):- — All significant deviations or non-conformance
Annual Product Quality Review — Results of the stability monitoring programme
84 (APQR):- and any adverse trends
Annual Product Quality Review —Adequacy of any other previous corrective
85 (APQR):- actions on product process or equipment
Annual Product Quality Review —All changes made to the processes or analytical
86 (APQR):- methods;

Annual Product Quality Review —All quality-related returns, complaints and

87 (APQR):- recalls and the investigations performed at the time
Annual Product Quality Review —Critical in-process controls and finished product
88 (APQR):- results;
Annual Product Quality Review
89 (APQR):- —Starting materials and packaging materials

Annual Product Quality Review —The qualification status of relevant equipment

90 (APQR):-
Aseptic Processing and
91 Sterilization by Filtration
Aseptic Processing and
92 Sterilization by Filtration
and utilities e.g. HVAC, water, or compressed gases
Specify the filter used for sterilization of solution by Don’t have Sterile
N/A
filtration. Facility
Specify the maximum possible time used for Don’t have Sterile
N/A
filtration process. Facility

7

INSPECTION SECTION NAME
Aseptic Processing and
93 Sterilization by Filtration
Aseptic Processing and
94 Sterilization by Filtration
Aseptic Processing and
95 Sterilization by Filtration
Aseptic Processing and
96 Sterilization by Filtration
97 Batch Packaging Records: -
98 Batch Packaging Records: -
99 Batch Packaging Records: -
100 Batch Packaging Records: -
101 Batch Packaging Records: -
102 Batch Packaging Records: -
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Don’t have Sterile
Specify the room classification of solutions N/A
Facility
preparation area which is sterilized by filtration.
Specify whether integrity of the sterilizing filters is Don’t have Sterile
verified before and after use. If so, by which N/A
Facility
method.
Specify whether the filling area is of Grade A N/A Don’t have Sterile
environment with Grade B background. Facility
Don’t have Sterile
Specify whether the personal working in the aseptic N/A
Facility
area are qualified for clean room procedure or not.
If so verify the training records.
Are packaging materials verified against a master
set to ensure that they are the most recent edition
and the correct materials for the batch?
Are the quantities of packaging materials verified
against the amounts stated as dispensed from the
warehouse?
Do the packaging materials arrive on a covered
trolley?
How line clearance is performed. Whether records
of line clearance is maintained according to
appropriate checklist.
Is any excess printed packaging material destroyed
on completion of the batch?
Is the batch yield calculated immediately upon
completion of packaging operation & prior to the
introduction of a new batch into the area?
8

INSPECTION SECTION NAME
103 Batch Packaging Records: -
104 Batch Packaging Records: -
105 Batch Packaging Records: -
106 Batch Packaging Records: -
107 Batch Packaging Records: -
108 Batch Packaging Records: -
109 Batch Packaging Records: -
110 Batch Packaging Records: -
111 Batch Packaging Records: -
112 Batch Packaging Records: -
Batch Processing /
113 Manufacturing Records:-
Batch Processing /
114 Manufacturing Records:-
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Is the yield calculation independently verified by
second individual and whether any significant
deviation from accepted yield is recorded and
investigated?
Is there a provision in the department for the
separation of printed packaging material for
destruction & rejected product?
Specify the monitoring code (bar code, pinholes
etc.) for final packing materials.
Specify whether all material, equipment, rooms and
packaging lines are labelled with an indication of
product being processed with batch no.
Whether Batch packaging record covered all the
points as prescribed in cGMP Guidelines.
Whether Batch packaging record covered all the
points as prescribed in WHO-TRS 986 & PIC/S
Whether all the documents generated during
packaging are attached with the Batch packaging
record.
Whether authorized packaging instructions for each
product of various pack size and type are
maintained and complied with.
Whether BPR are based on current master formula
record.
Whether packaging lines are independent and
adequately segregated.
Whether BPR / BMR covered all the points as
prescribed in cGMP Guidelines.
Whether BPR / BMR covered all the points as
prescribed in WHO-TRS 986 & PIC/S
9

INSPECTION SECTION NAME
Batch Processing /
115 Manufacturing Records:-
Batch Processing /
116 Manufacturing Records:-
117 Building and Premises
118 Building and Premises
119 Building and Premises
120 Building and Premises
121 Building and Premises
122 Building and Premises
123 Building and Premises
124 Cleaning Validation
125 Cleaning Validation
126 Cleaning Validation
127 Cleaning Validation
128 Cleaning Validation
129 Cleaning Validation
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether all the documents generated during Batch
production are attached with the BPR /BMR
Whether the BPR/BMR for each product is prepared
on the basis of currently approved master formula.
Air Handling System is available with dedicated
AHUs.
Drainage system is well maintained with no open
drains in processing areas
The interior suface of building are smooth and free
from cracks to permit easy cleaning. The building
material is appropriate
The lux level is appropriate for manufacturing. In
case of light sensitive materials monochromic light
with low lux is provided
The pest, insects, birds and rodents control system
followed in the premises. Specify pest control
schedule- area wise, along with materials and
methods used.
The surrounding of the facility is clean and
appropriate for Pharmaceutical Plant.
The whole facility is separated and is not a part of
any other non-drug facility.
1 )Surfaces in contact with the product
1) Visually clean.
2) 10 ppm in another product.
2) After a change in product
3) 0.1% of the therapeutic dose?
3) Between shift batches.
10

INSPECTION SECTION NAME
130 Cleaning Validation
131 Cleaning Validation
132 Cleaning Validation
133 Cleaning Validation
134 Cleaning Validation
135 Cleaning Validation
136 Cleaning Validation
137 Cleaning Validation
138 Cleaning Validation
139 Cleaning Validation
140 Cleaning Validation
141 Cleaning Validation
Complaints and Adverse
142 Reactions:-
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Analytical method, Acceptance Criteria, Swab
recovery test,
Does the protocol define the selection criteria for
products or groups of products subject to cleaning
validation?
Is a validation performed to confirm cleaning
effectiveness?
Is data produced supporting the conclusion that
residues were removed to an acceptable level?
Signatures of the Quality Assurance Manager,
Signature of the employee in charge of cleaning
verification from Production and Quality Control.
Specify whether acceptance limits been set for
cleaning verification and are based on following
criteria:
Specify whether detergent residues and
degradation products are investigated during
validation.
Specify whether the validation is implemented to
verify cleaning of:
Specify whether the Validation Strategy include
contamination risks & equipment storage time.
Whether personnel engaged in cleaning, sampling
etc. trained.
Whether Quality Control responsible of the
sampling for cleaning verification?
Whether validation records include : Recovery study
data,
Are complaints reviewed on a timely basis by the
Quality Assurance unit?
11

INSPECTION SECTION NAME
Complaints and Adverse
143 Reactions:-
Complaints and Adverse
144 Reactions:-
Complaints and Adverse
145 Reactions:-
Complaints and Adverse
146 Reactions:-
Complaints and Adverse
147 Reactions:-
Complaints and Adverse
148 Reactions:-
Complaints and Adverse
149 Reactions:-
150 Data Integrity
151 Data Integrity
152 Data Integrity
153 Data Integrity
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Are complaints, whether received in oral or written
form, documented in writing, and retained in a
designated file?
Are there any criteria for action to be taken on the
basis of nature of complaint / adverse reaction?
How records of complaint and adverse reactions
maintained.
Is CAPA process followed in response to each
complaint documented?
Specify the review system for complaints
concerning the quality of products.
Specify whether system of route cause analysis is
followed by the firm on the complaint of adverse
drug reaction.
Whether the firm has provided Pharmacovigilance
department for analysing complaints of adverse
drugs reactions resulting from the use of a drug.
How Excel sheets are validated if calculation are
done in Excel sheet.
Whether audit trails related to project creation
(study creation), project (study) modification,
deletion etc. are available.
Whether right to access and modify are with two
different individuals. If yes how QA is involved in
modification of data.
Whether rights to work, amend, modify, delete are
specified in written document.
12

INSPECTION SECTION NAME
154 Data Integrity
155 Data Integrity
156 Data Integrity
157 Data Integrity
158 Data Integrity
Dissolution Apparatus
159 Calibration
Dissolution Apparatus
160 Calibration
Dissolution Apparatus
161 Calibration
Dissolution Apparatus
162 Calibration
Dissolution Apparatus
163 Calibration
Dissolution Apparatus
164 Calibration
Dissolution Apparatus
165 Calibration
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether the data is backed up at regular intervals.
If yes what is the written back up policy. The data
backup must be server based.
Whether the firm has QA SOP for review of data
integrity or audit trail. If yes how the modification
and deletions are reviewed.
Whether the firm has software based
manufacturing and testing equipment
Whether the individuals are provided log in IDs for
access. All login and logout information should be
available.
Whether the records are completed at the time of
the operation and are legible maintained with raw
data if applicable and no falisification of data
observed.
Verify the records of calibration of following
parameters:
[Verify whether dissolution is calibrated against
standard prednisolone tablets]
—Checking of distance between inside bottom of
the vessel & Basket
—Checking of distance between inside bottom of
the vessel & paddle
—Checking of RPM
—Checking of Temperature
—Checking of Timer: Calibrate against standard
stop watch
13
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Dissolution Apparatus
166 Calibration —Checking of Wobbling of Basket
Dissolution Apparatus
167 Calibration —Checking Wobbling of paddle
Dissolution Apparatus
168 Calibration —Performance verification test

14

INSPECTION SECTION NAME
169 Documentation and Records
170 Documentation and Records
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Do the manufacturing records pertaining to
manufacture of Sterile & Non- Sterile products
indicate the following details: Serial number of
Batch Manufacturing ,Record ,Name of the
product, Reference to Master Formula Record,
Batch/ Lot number, Batch/ Lot size, Date of
commencement and completion of manufacture,
Date of manufacture and assigned date of expiry,
Date of each step in manufacturing, Names of all
ingredients with reference number given by the
quality control department ,Quantity of all
ingredients, Time and duration of blending, mixing
etc. where ever applicable, PH of solutions
whenever applicable, Filter integrity testing records,
Temperature and humidity records whenever
applicable, Records of plate-counts whenever
applicable, Results of bacterial endo-toxin and
toxicity, Records of weight or volume of drug filled
in containers, Bio burden records before
sterilisation, Leak test records, Inspection records,
Sterilization records including load details, date,
duration, temperature, pressure etc. Container
washing & testing records, Total number of
containers filled, Total number of containers
rejected at each stage, Theoretical yield, permissible
yield, actual yield and variation there of,
Clarification for variation in yield ,beyond
How the documents are designed, prepared,
reviewed and controlled to provide an audit trail.
15

INSPECTION SECTION NAME
171 Documentation and Records
172 Documentation and Records
173 Documentation and Records
174 Documentation and Records
175 Documentation and Records
176 Documentation and Records
177 Documentation and Records
178 Documentation and Records
179 Environmental Monitoring
180 Environmental Monitoring
181 Environmental Monitoring
182 Environmental Monitoring
183 Environmental Monitoring
184 Environmental Monitoring
185 Environmental Monitoring
186 Environmental Monitoring
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify the duration of retaining the documents
after the expiry of the respective product and who
is responsible for its maintenance.
Whether all daily documents are filled correctly and
timely.
Whether data is recorded by electronic data
processing system or by other means. If by
electronic data processing system then how access
is controlled to enter, modify etc. the data.
Whether documents are approved signed and dated
by appropriate and authorized person.
Whether documents are regularly reviewed and
kept up to date.
Whether documents specify title, nature and
purpose.
Whether master formula and detailed operating
procedures for each product are available?
Whether the records are made at the time of each
operation in such a way that all significant activities
concerning to the production are traceable.
Compliance 2-4 Persons during
1) No. of Persons monitoring
1) Particulate counts Compliance
2) ACPH (Air Changes per hours) Compliance
2) HEPA filters integrity testing Compliance
3) Air Change rates Compliance
3) Particle count (Static & Dynamic) Compliance
4) Air pressure differentials Compliance
4) Viable count (Static & Dynamic) Compliance
16

INSPECTION SECTION NAME
187 Environmental Monitoring
188 Environmental Monitoring
189 Environmental Monitoring
190 Environmental Monitoring
191 Environmental Monitoring
192 Environmental Monitoring
193 Environmental Monitoring
194 Environmental Monitoring
195 Environmental Monitoring
196 Environmental Monitoring
197 Environmental Monitoring
198 Environmental Monitoring
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
5) Temperature & Humidity Compliance
5) Temperature and Humidity Compliance
6) Air Sampling location and interpretation of results Compliance
(Both viable and non-viable)
6) Microbiological monitoring by settle plates and/ Compliance
or swabs in Critical areas & Other areas
7) Whether the above method is in compliance with Compliance
ISO 14644-1
8) Action and Alert limits for all the above Compliance
parameters
Does a written Environmental Monitoring Program Compliance
exist?
Partial Don’t have Grade-A in
How long the settle plates are exposed in Grade A Compliance Production but have
and other areas. (1 Hour) Grade-C & D
Mention the periodic monitoring frequencies of the
followings:
Specify the temperature and humidity maintained Compliance Daily
in the critical areas.
Monthly for
Specify what parameters are reassessed and Non-Viable
Non-Sterie
approved before starting production and in case of especially
Facility
major engineering modifications being carried out
to the HVAC system of any area.
Verify the area qualification records and specify
whether the following were taken into
consideration :
17
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

Verify the records of microbiological results also

199 Environmental Monitoring
200 Environmental Monitoring
201 Equipment
specify whether alert and actions limits are followed Compliance Limits are followed
or not.
What action is taken in case particulate and
microbiological monitoring counts exceed the
limits?
Are there cleaning agent labelled with a catalogue
no. indicating that they were received through the
warehouse.

202 Equipment Are there records for preparation of cleaning agent?

Please specify the procedures to clean the
203 Equipment equipment after each batch production.
Specify if filter integrity test is carried out before
204 Equipment and after the sterile filtration process.
Specify if suitable vent filters and recording
thermographs are provided for autoclaves & dry
205 Equipment heat sterilizers.
Specify material of construction of contact parts of
206 Equipment the production equipments.
Specify SOPs available for each equipment for its
207 Equipment operation and cleaning.
Specify the initial effectiveness of sterilization
process established by using microbial spore
208 Equipment indicators.
Specify the material of construction of the
209 Equipment equipment & type of glass containers

Specify the procedures to clean the equipment after

210 Equipment each batch production and verify with the SOP.

18
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify the procedures to remove defective
211 Equipment equipments from production areas.
212 Equipment Specify the qualifications of critical equipment.
213 Equipment Specify the tubing used in critical areas
Specify whether a written calibration program is
214 Equipment available
Specify whether calibration status documented and
215 Equipment displayed on the equipment and the gauges
216 Equipment Specify whether CIP or SIP is in place.
Specify whether cool air is passed through HEPA
filter and recording thermographs provided in DHS
217 Equipment (Dry Heat Sterilization)/Tunnel.
Specify whether provisions of CIP or SIP are
218 Equipment available.
219 Equipment Specify whether pure steam is in use.
220 Equipment Specify whether the CIP / SIP system is qualified
Specify whether the measuring devices attached to
221 Equipment equipment calibrated at suitable intervals.
Specify whether the unit- sterilizers are double
ended with suitable inter-locking between the
222 Equipment doors.

Specify whether thermal Mapping of heat sterilizers

223 Equipment is carried out on regular basis. Check records.
Verify the qualification, protocol and reports for the
224 Equipment critical equipment.
Verify whether washing and cleaning of equipment
225 Equipment are not a source of contamination.

226 Equipment Whether all equipment are provided with log book.

19
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
227 Equipment Whether all equipment is provided with an ID NO.

Whether balances and other measuring equipments

with appropriate range are available in the Raw
Material stores & production areas and they are
calibrated in accordance with SOP maintained.
228 Equipment Specify the calibration schedule of the balances.
Whether separate area is provided for storage of
229 Equipment machine parts etc.

Whether the equipment are designed aiming to

minimize risk of error and permit effective cleaning
and maintenance in order to avoid cross
230 Equipment contamination & build up of dust.
Whether validity period for use after the cleaning of
231 Equipment equipment is specified.
Which types of lubricants are used in the
equipment. Specify the quality and control
232 Equipment reference No. of these lubricants
Specify the storage arrangement of finished
233 Finished Product:- products after final release by QA
Specify whether finished products are held in
234 Finished Product:- quarantine until their final release.
Verify the records of calibration of following
235 FTIR parameters:
236 FTIR —Control of resolution performance
237 FTIR —Verification of the wave number scale
Are garments,masks,gloves are changed at every
238 Garments work session?
239 Garments Are powder free gloves used in clean rooms
240 Garments Are safety goggles sanitized by a suitable method

20
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
241 Garments Are the foot-wear daily cleaned with a bactericide
Are the foot-wear used made of plastic or rubber
242 Garments material
Are the gloves long enough to cover the wrists
completely and allow the over-all cuff to be tucked
243 Garments in
Are the gloves used made of latex or other suitable
244 Garments plastic material
Are the safety goggles / numbered glasses worn
245 Garments inside the critical areas and have side extensions
if full size mirror has been provided in the final
change room to ascertain that the operator has
246 Garments appropriately attired in the garments.
Specify how the garments used in clean areas are
247 Garments cleaned and sterilized.
248 Garments Specify the garment changing procedure and SOPs
Specify the process of sterilization of the garments
& the practise followed to carry the sterilised
249 Garments garments to the final change room.
250 Garments Specify type of garments used in critical areas?
251 Garments Specify type of Zips used in garments
Specify whether operators are trained in garment
252 Garments changing procedure.

253 Garments Whether garments used in critical areas are sterile.

Specify whether employees are encouraged to

report sickness or whether employees are not
Health, Clothing and Sanitation punished for seak leave in various forms eg. Upaid
254 of Workers sick leave etc..

21
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Health, Clothing and Sanitation Specify if any unhygienic practise is observed within
255 of Workers the manufacturing areas.
Specify whether cross over bench is in place in the
Health, Clothing and Sanitation change room and if so step over bench are not
256 of Workers meant to prevent dust particles .Step.
Health, Clothing and Sanitation Specify whether person from infectious disease is
257 of Workers barred to enter into production area.
Whether all personnel are trained to ensure high
Health, Clothing and Sanitation level of personal hygiene. Mention the SOP no.
258 of Workers followed in this regard.

Whether all personnel prior to employment have

undergone medical examination including eye
examination and are all free from Tuberculosis, skin
Health, Clothing and Sanitation and other communicable or contagious diseases &
259 of Workers thereafter at at least every year .
Health, Clothing and Sanitation Whether arrangements provided for cleaning of
260 of Workers outside dust and dirt from foot.
Health, Clothing and Sanitation Whether investigational reports, e.g. of X rays etc.
261 of Workers preserved.
Health, Clothing and Sanitation Whether records of such medical examination are
262 of Workers maintained thereof
Verify the records of calibration of following
263 HPLC Calibration parameters:
264 HPLC Calibration — Auto Sampler Carry over.
265 HPLC Calibration — Calibration of Auto injector.
266 HPLC Calibration — Calibration of Detector.
— Calibration of Gradient proportionate valve
267 HPLC Calibration (GPV).
268 HPLC Calibration — Calibration of pump.
269 HPLC Calibration — Manual injector calibration

22
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
270 HPLC Calibration — Sample Trays compartment.
271 HPLC Calibration — System suitability

272 HPLC Calibration — Temperature calibration for Column oven and
Internal Quality / GMP Audit Does a formal auditing function exist in the Quality
273 Programme Assurance department?
Does a written SOP specify the scope and frequency
Internal Quality / GMP Audit of audits and how such audits are to be
274 Programme documented?
Does a written SOP specify who shall conduct audits
Internal Quality / GMP Audit and qualifications (education, training, and
275 Programme experience) for those who conduct audits?
Specify whether record is maintained for CAPA on
Internal Quality / GMP Audit the basis of self quality audit / inspection and
276 Programme whether same is reviewed by the management
Labels and Other Printed How printed labels (art work) are approved. Verify
277 Materials:- the SOP.
Labels and Other Printed
278 Materials:- Specify whether cut labels or rolled labels are used.
Labels and Other Printed Whether the labels comply with requirements of
279 Materials:- Rule 96 & 97 & other relevant provisions
Labels and Other Printed Whether the printing is in bright colour and legible
280 Materials:- on labels and other printed materials?
Manufacturing Operations and If yes, pls give brief account of measures taken to
281 Controls assure freedom from pathogens.
Manufacturing Operations and Is the personnel clothing clean, unstained & dust
282 Controls free, including shoes?
Manufacturing Operations and Is there a cleaning SOP for slippers or shoes that is
283 Controls being used in the manufacturing area?

23
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Manufacturing Operations and
284 Controls Is there an approved SOP for In process check?
Specify whether all critical activities of production
Manufacturing Operations and and testing is carried out under the direct
285 Controls supervision of competent technical staff.
Manufacturing Operations and Specify Whether any deviation is approved in
286 Controls writing by a designated person and recorded.

Verify whether handling of materials and products

Manufacturing Operations and are carried out in accordance with the relevant
287 Controls SOP’S.
Manufacturing Operations and Whether process hold time studies has been carried
288 Controls out for various stages of production

Whether the contents of all vessels and containers

used in manufacture and storage is conspicuously
labelled with the name of the products. Batch no,
Manufacturing Operations and Batch Size, and stage of manufacture along with
289 Controls signature of technical staff.
Whether the products not prepared under aseptic
Manufacturing Operations and conditions are free from pathogens like Salmonella,
290 Controls Escherichia coli, Pyocyanea etc.
Is each lot of the finished product filled in one
291 Manufaturing Process continuation operation?

Specify the minimum possible time between the

292 Manufaturing Process
293 Manufaturing Process
preparation of the solution and its sterilization or
filtration through microorganism retaining filters
followed.
Specify the porosity of the filters when any external
gases are coming into contact with the sterile
product.

24

INSPECTION SECTION NAME
294 Manufaturing Process
295 Manufaturing Process
296 Manufaturing Process
297 Manufaturing Process
298 Manufaturing Process
299 Manufaturing Process
300 Manufaturing Process
301 Master Formula Records: -
302 Master Formula Records: -
303 Master Formula Records: -
304 Master Formula Records: -
305 Microbiology Lab
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify the procedure of sterilization of washed
containers.
Specify whether all critical process is validated.
Verify the records.
Specify whether critical operations are carried out in
closed system.
Specify whether gas cylinders are kept out side of
the critical areas.
Specify whether the bulk raw materials and bulk
solutions monitored for bio-burden periodically
(solutions not to contain more than 100 cfu/ml).
Specify whether the sterilized containers not used
within an established time, rinsed with WFI and re-
sterilized.
Verify the process validation protocol and reports
for the critical operation.
How master formula records for each product are
prepared, authorized and controlled.
Whether master formula is batch size specific.
Whether master formula record covered all the
points as prescribed in WHO-TRS 986 & PIC/S
guidelines
Whether master formula record covers all the
points as prescribed in cGMP Guidelines.
MLT Room
Separate Entry & Exit
Briefly describe layout of the microbiology lab supported by
ways
(attach copy of the layout if available) Airlocks
25
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Grade-A supported by
Grade-C, Prssure
Specify the air class of sterile areas and whether Compliance
Differential
pressure difference is maintained. Verify the maintained
306 Microbiology Lab records.
307 Microbiology Lab Specify the Air Grades for following areas:

Specify the Calibration procedure of temperature Temperature sensors

measurement devices used in autoclave and Compliance are calibratied
incubator. Verify whether it is traceable to standard externally
308 Microbiology Lab temperature.
Specify the gowning procedure to enter the sterile Compliance
309 Microbiology Lab area. Verify the entry and exit records.

Metod Validation
Specify the procedure followed to verify the validity Compliance Protocol
310 Microbiology Lab of the test in case of antibiotic potency testing.

ATCC Culture,
Specify the source of procurement of reference Compliance Approved Vendor List
311 Microbiology Lab culture and its maintenance.
Specify the type of workstations (LAF) provided in Vertical Airflow
Compliance
312 Microbiology Lab the sterile area. Cabinet

Specify whether access in sterile area is controlled, Compliance

313 Microbiology Lab and if so the system followed in this regard
Specify whether a documented cleaning and Compliance
314 Microbiology Lab disinfection programme is in place.
Specify whether a procedure for dealing with
315 Microbiology Lab spillages in sterile area is in place.

Specify whether an environmental monitoring Compliance Limits are followed

316 Microbiology Lab programme is followed with alert and action limit.

26
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
It is carriedout on
Specify whether GPT (growth promotion test)is Compliance each and every new
317 Microbiology Lab carried out for dehydrated media. pack

Specify whether operators are trained in gowning Compliance Trained

318 Microbiology Lab procedures. Verify the training records.

Specify whether performance of culture media Compliance It is included in GPT

(recovery or survival maintenance) is carried out
319 Microbiology Lab and the results meet acceptance criteria.

Specify whether qualification of all equipment and

instruments used in this department is covered Compliance Covered
320 Microbiology Lab under VMP.
Specify whether the Vendors for dehydrated media Compliance Approved
321 Microbiology Lab is approved and qualified.
Same autoclave but
Specify whether there is separate autoclave for No runs separately
322 Microbiology Lab decontamination. .

Verify how the concentration of the inoculums is Compliance Serial Dilution

323 Microbiology Lab determined.
Verify the area qualification document for sterile Compliance Verified
324 Microbiology Lab area.
325 Microbiology Lab Verify the following records:

Verify the list of equipment used in the Compliance Verified

microbiological lab and also specify whether these
326 Microbiology Lab are placed logically and function accurately

27
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

Don’t have Sterile

Verify the procedure for selection of sampling Facility, Non-Sterile
location and interpretation of results for Compliance Facility is monitored in
environmental monitoring of sterile area along with accordance with ISO-
the SOP and documents. (Specify whether the 14664-1
327 Microbiology Lab method is in compliance with ISO 14644-1).
Verify the procedure for the handling and disposal Compliance
328 Microbiology Lab of chemical and microbial waste.

Verify the qualification document of major

equipment like autoclave/incubator, hot air oven, Compliance Qualified
329 Microbiology Lab refrigerator, LAF etc.

Whether double door autoclave is provided for

transferring of materials from unclassified area to N/A
330 Microbiology Lab sterile area.

Partial Single airlock system

Whether entry to the sterile area is through three Compliance for MLT Room
331 Microbiology Lab air lock systems with separate exit

Whether firm has provided microbiology lab for

MLT test for nonsterile dosage form. If no how this Compliance MLT Room provided
332 Microbiology Lab test is complied.
Whether separate AHUs are provided for Compliance Separate AHU
333 Microbiology Lab microbiological testing areas.

Don’t have Sterile

Partial Facility but MLT as
Whether separate areas provided for sterility Compliance well as AET performed
testing, assay of antibiotics & vitamins and MLT in in Grade-A
334 Microbiology Lab sterile area.
Whether support areas are under same AHU which Compliance Yes
335 Microbiology Lab is used for sterile area.

28

INSPECTION SECTION NAME
336 Microbiology Lab
337 Microbiology Lab
338 Microbiology Lab
339 Microbiology Lab
340 Microbiology Lab
341 Microbiology Lab
342 Microbiology Lab
343 Microbiology Lab
344 Others
345 Others
346 Others
347 Pharmaceutical Development
348 Pharmaceutical Development
349 Pharmaceutical Development
350 Pharmaceutical Development
Pharmaceutical Quality
351 Management System (PQS)
Pharmaceutical Quality
352 Management System (PQS)
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
—Airlocks (entry and exit both) Compliance
N/A
—Log book for the entry/exit in the sterile area
—media preparation record Compliance Available
—Microbiological Assay room Compliance Available
—MLT room Compliance Available
—records for MLT Compliance Available
—records for water testing (micro) Compliance Available
—Sterility testing room N/A
Specify whether products released only after
complete filling and testing.
Specify whether result of the tests relating to Don’t have Sterile
sterility, bacterial endo-toxins are maintained in the N/A
Products
analytical records
Whether process hold time studies has been carried
out for various stages of production
Whether firm has adopted latest tools (quality by
design) to develop new products.
Whether firm hires consultants for technology
transfer. If so details thereof.
Whether formulation development facility up to
development of exhibit batches available.
Whether there is Research and Development facility
available.
Give synopsis of last two management review
meeting held by the firm
Specify the management responsibility defined as
per the quality manual
29

INSPECTION SECTION NAME
Pharmaceutical Quality
353 Management System (PQS)
Pharmaceutical Quality
354 Management System (PQS)
Pharmaceutical Quality
355 Management System (PQS)
Pharmaceutical Quality
356 Management System (PQS)
Precautions against Mix-ups
357 and Cross Contamination
Precautions against Mix-ups
358 and Cross Contamination
Precautions against Mix-ups
359 and Cross Contamination
Precautions against Mix-ups
360 and Cross Contamination
Precautions against Mix-ups
361 and Cross Contamination
Precautions against Mix-ups
362 and Cross Contamination
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify the performance indicators presently
followed by the firm to monitor the effectiveness of
PQS like product quality monitoring, CAPA, change
management and management review
Specify the Procedures followed for continual
improvement of process performance and product
quality
Specify whether life cycle approach is followed
whether purchases are also included under PQS
Are doors of all core areas closed at all times with
interlock arrangements?
Do all the areas have their own independent air
locks separately for men and material entry.
How access of authorized persons to manufacturing
areas including packaging is controlled.
How line clearance is performed. Whether records
of line clearance is maintained according to
appropriate checklist.
Please specify how temperature, humidity and air
filtration are controlled in the areas where raw
material and/or products are exposed and handled
Please specify what measures has been taken to
prevent contamination of products with Beta
Lactam Antibiotics, Sex hormones and cyto toxic
substances.
30

INSPECTION SECTION NAME
Precautions against Mix-ups
363 and Cross Contamination
Precautions against Mix-ups
364 and Cross Contamination
Precautions against Mix-ups
365 and Cross Contamination
Precautions against Mix-ups
366 and Cross Contamination
Precautions against Mix-ups
367 and Cross Contamination
Precautions against Mix-ups
368 and Cross Contamination
Precautions against Mix-ups
369 and Cross Contamination
Precautions against Mix-ups
370 and Cross Contamination
Precautions against Mix-ups
371 and Cross Contamination
Precautions against Mix-ups
372 and Cross Contamination
Precautions against Mix-ups
373 and Cross Contamination
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Pls specify the areas of dust generation and
mechanism involved in controlling the dust
Specify the methods followed for product change-
over.
Specify whether any SOP is followed to verify the
effectiveness for prevention of cross contamination.
Specify whether critical operations are carried out in
closed system.
What criteria of pressure differential has been set
for production v/s adjoining areas.
What measures has been taken to prevent mix- ups
during various stages of production.
Whether equipments use for production are
labelled with their current status.
Whether packaging lines are independent and
adequately segregated.
Whether processing of sensitive drugs like Beta
lactam Antibiotics and Sex Hormones is done in
segregated areas with independent AHU and proper
pressure differentials along with demonstration of
effective segregation of these areas with records.
Whether proper AHU, pressure differential,
segregation, status labelling have been provided to
prevent mix-up and cross-contamination in
manufacturing area
Whether segregated secured areas for recall or
rejected materials or for such material which are to
be processed or recovered are provided.
31

INSPECTION SECTION NAME
Precautions against Mix-ups
374 and Cross Contamination
Precautions against Mix-ups
375 and Cross Contamination
Precautions against Mix-ups
376 and Cross Contamination
Product Containers and
377 Closures:-
Product Containers and
378 Closures:-
Product Containers and
379 Closures:-
Product Containers and
380 Closures:-
Product Containers and
381 Closures:-
Product Containers and
382 Closures:-
383 Product Recalls:-
384 Product Recalls:-
385 Product Recalls:-
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether separate carton coding area has been
provided or online carton coding is performed How
carton coding procedure is controlled.
Whether separate gowning provision is followed
before entering the core areas.
Whether various operations are carried out in
segregated areas.
Specify whether a written procedure exist for
washing of glass ampoules/vials.
Specify whether containers and the closures are
finally washed with WFI before sterilization.
Specify whether Specifications, Test methods,
Cleaning procedures, Sterilizing procedures etc. are
available of the containers/ closures and other
component parts of drug packages.
Specify whether the container & closures are
compatible with the product without affecting its
quality and purity. Verify the records.
Specify whether the containers and closures used
comply with pharmacopoeia or other specific
requirements.
Specify whether the material quality of the stoppers
and closures ensures that it does not affect the
quality of the product and avoids the risk of toxicity.
Are distribution records available for a prompt recall
of products from the market?
Specify the product recall system.
Verify the procedure followed to handle the
recalled products
32
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Verify the SOP for recall of products clearly defining
responsibility, procedure reporting, econciliation
386 Product Recalls:- etc.
Production Area for Non Sterile
387 Preparations Is there any cris cross flow of materials and men?
Production Area for Non Sterile Specify how service lines are identified for nature of
388 Preparations supply and direction of the flow.
Production Area for Non Sterile Specify the position of IPQC lab in the
389 Preparations manufacturing area.
Production Area for Non Sterile Specify the procedures for entry of maintenance
390 Preparations people into the production area.
Production Area for Non Sterile Specify the provisions for storage of dirty, washed
391 Preparations and cleaned equipment in process areas.
Production Area for Non Sterile Specify whether non storage areas are used for
392 Preparations storage of any material.
Production Area for Non Sterile Verify whether access to production area is
393 Preparations restricted to authorised personnel only.

Whether entry and exit doors, for materials and

personnel, have an interlock mechanism or other
Production Area for Non Sterile appropriate system to prevent the opening of more
394 Preparations than one door at a time.
Whether service lines in production areas are
Production Area for Non Sterile through service pendants. If not, how they are
395 Preparations placed so as to avoid accumulation of dust.
Production Area for Non Sterile Whether the change rooms have an arrangement
396 Preparations with step-over/cross-over bench.
Whether the facility is provided with a well-sealed
Production Area for Non Sterile structure with no air leakage through ceilings,
397 Preparations cracks or service penetrations.

33

INSPECTION SECTION NAME
Production Area for Non Sterile appropriately designed and installed to facilitate
398 Preparations
Production Area for Sterile
399 Preparation
Production Area for Sterile
400 Preparation
Production Area for Sterile
401 Preparation
Production Area for Sterile
402 Preparation
Production Area for Sterile
403 Preparation
Production Area for Sterile
404 Preparation
Production Area for Sterile
405 Preparation
Production Area for Sterile
406 Preparation
Production Area for Sterile
407 Preparation
Production Area for Sterile
408 Preparation
Production Area for Sterile
409 Preparation
Production Area for Sterile
410 Preparation
Production Area for Sterile
411 Preparation
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether the premises and equipment are
cleaning and decontamination.
1) Walls are flat, smooth and devoid of recesses.
1) Washing of containers & closures
2) Storage of washed containers & closures
2) Surface joints like electric sockets, gas points
flushed with walls.
3) Joints in the ceiling are properly sealed
3) Sterilization of containers & closures
4) Air grills and lights flushed with the ceiling.
4) Preparation of bulk solution ( critical/non critical)
5) Change room
5) Grade A & B areas devoid of sinks and drains.
6) Doors and windows made up of non shedding
materials.
7) Doors open towards higher pressure areas and
close automatically due to air pressure.
Are the critical and support areas provided with
intercom telephones or speak phones for
communication purposes.
34

INSPECTION SECTION NAME
Production Area for Sterile
412 Preparation
Production Area for Sterile
413 Preparation
Production Area for Sterile
414 Preparation
Production Area for Sterile
415 Preparation
Production Area for Sterile
416 Preparation
Production Area for Sterile
417 Preparation
Production Area for Sterile
418 Preparation
Production Area for Sterile
419 Preparation
Production Area for Sterile
420 Preparation
Production Area for Sterile
421 Preparation
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Are the location of services like water, steam, gases
etc. Such that the servicing or repairs can be carried
out without any threat to the integrity of the facility
Change rooms entrance provided with air locks
before entry to the sterile product manufacturing
areas.
Fire extinguishers are suitably fastened to the walls
without gaps.
How many change rooms are provided to enter into
the critical areas?
Is there a glass panel between critical area &
support area so that all operations in Grade A & B
areas can be supervised from support areas?
Quality of the furniture used is smooth & washable
and made of SS316.
Specify an appropriate inter- locking system with
visual and/or audible warning system installed to
prevent the opening of more than one door at a
time.
Specify de-cartoning areas to remove outer
cardboard wrappings of primary packaging
materials segregated from the washing areas.
Specify in the classified areas:
Specify the building is devoid of cracks especially in
the Critical solutions preparation rooms, Filling
rooms, Sealing rooms.
35

INSPECTION SECTION NAME
Production Area for Sterile
422 Preparation
Production Area for Sterile
423 Preparation
Production Area for Sterile
424 Preparation
Production Area for Sterile
425 Preparation
Production Area for Sterile
426 Preparation
Production Area for Sterile
427 Preparation
Production Area for Sterile
428 Preparation
429 Quality Assurance:-
430 Quality Assurance:-
431 Quality Assurance:-
432 Quality Assurance:-
433 Quality Assurance:-
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify the critical areas and support areas provided
with suitable air- locks or pass boxes with proper
interlocking arrangements for material transfer.
Specify the manufacturing areas clearly separated
into following Support Areas:
Specify the method of transfer of sterile rubber
bungs & aluminium caps to the aseptic area.
Specify water lines pose any threat of leakage to the
critical area
Specify whether dynamic pass box is used for
material transfer between two different air class.
Specify whether grade A/B area is devoid of sinks
and drains.
Specify whether particle shedding materials like
wooden pallets, fibre board drums, cardboards etc.
are taken into the preparation areas.
How deviation are controlled. Verify SOP and three
recent deviations. Specify whether all deviations are
reported and records maintained.
Is the production batch record and release test
results reviewed for accuracy and completeness
before a batch/lot of finished product is released?
Mention the change control procedures & examine
three recent change control forms.
Mention the documents prepared and maintained
by QA department
Specify the procedure followed by QA department
to ensure the implementation of all SOPs in the
plant.
36

INSPECTION SECTION NAME
434 Quality Assurance:-
435 Quality Assurance:-
436 Quality Assurance:-
437 Quality Assurance:-
438 Quality Assurance:-
439 Quality Assurance:-
440 Quality Assurance:-
441 Quality Control Area: -
442 Quality Control Area: -
443 Quality Control Area: -
444 Quality Control Area: -
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify the procedures followed to ensure CAPA
process. Verify the SOP and three recent records in
this regard.
Specify the responsibility of the QA Head.
Specify whether any procedure is followed for
preparation of SOPs and its circulation to all
concerned. How master, controlled and
uncontrolled copy of SOPs are processed.
Specify whether QA is responsible for review of
production batch record and test results before
product is released in the market
Verify the checklist and SOP in this regard.
Verify the total list of SOPs maintained by QA and
how QA ensure that no obsolete SOP is in
circulation.
Whether QA is involved in control of starting
materials, intermediate products, bulk products,
process controls, calibrations, validation and release
of finish goods.
Specify the arrangement provided to protect
sensitive electronic balances from vibrations,
electrical interference, humidity etc.
Specify the procedure followed for
approval/rejection of raw materials, packaging
materials, intermediate products and finished
products. Verify the SOP and record.
Specify the safety measures taken to avoid any
accidental hazards in the QC department.
Specify the working space provided for QC:
37

INSPECTION SECTION NAME
445 Quality Control Area: -
446 Quality Control Area: -
447 Quality Control Area: -
448 Quality Control System: -
449 Quality Control System: -
450 Quality Control System: -
451 Quality Control System: -
452 Quality Control System: -
453 Quality Control System: -
454 Quality Control System: -
455 Quality Control System: -
456 Quality Control System: -
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify whether QC area is independent of
production area.
Specify whether separate washing and drying area is
provided for glassware
Specify which grade of glassware is used in assay
procedures and whether they are
certified/calibrated. Verify the certificates and
calibration records.
How the reference standards are stored, evaluated
and maintained.
Is there a maximum time limit for retention of
sample in the laboratory prior to testing?
Is there any SOP for handling of OOS product (out of
specification)?
Specify procedures for safe removal of waste from
the laboratory.
Specify the procedure followed for issuance of COA.
Specify the procedure followed for preparation,
consumption & destruction of volumetric solution.
Verify the SOP and records.
Specify the procedure followed for receiving and
recording (logging in). Verify the SOP and records
Specify the procedure followed for storage of
samples after testing.
Specify the procedure followed for using GR
(guaranteed Reagent), LR (Lab Reagent)and
AR(Analytical reagent) grade of chemicals / solvents
used for calibration & sample testing.
38

INSPECTION SECTION NAME
457 Quality Control System: -
458 Quality Control System: -
459 Quality Control System: -
460 Quality Control System: -
461 Quality Control System: -
462 Quality Control System: -
463 Quality Control System: -
464 Quality Control System: -
465 Quality Control System: -
466 Quality Control System: -
467 Quality Control System: -
468 Quality Control System: -
469 Quality Control System: -
470 Quality Control System: -
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify the procedure for retention of samples after
testing is completed.
Specify the procedure for review of test data &
calculations.
Specify the procedure for storage and distribution
of received samples to different analyst.
Specify the procedure of reporting the result of
analysis by the analyst to QC Head.
Specify the source of procurement of various
reference standards
Specify whether a designated person is responsible
for receipt of samples for testing.
Specify whether approved specifications are
available for all:
Specify whether authorized access system is
followed for reference standards.
Specify whether raw materials, intermediates and
finished product testing is carried out as per
specifications and raw data is maintained.
Specify whether respective STP is followed by the
analyst for analysis.
Specify whether there is a log book for the
preparations of the reagent including name of the
analyst, name of the reagent, Calculations, Date of
preparation & expiration.
Verify the sampling SOPs and records for:
Verify the SOP and records for destruction of
unused working standard
Verify the SOP and records for preparation of
working standard from the reference standard.
39

INSPECTION SECTION NAME
471 Quality Control System: -
472 Quality Control System: -
473 Quality Control System: -
474 Quality Control System: -
475 Quality Control System: -
476 Quality Control System: -
477 Quality Control System: -
478 Quality Control System: -
479 Quality Control System: -
480 Quality Control System: -
481 Quality Control System: -
482 Quality Control System: -
483 Quality Control System: -
484 Quality Control System: -
485 Quality Control System: -
486 Quality Control System: -
487 Quality Control System: -
488 Quality Control System: -
489 Quality Control System: -
Quality Risk Assessment
490 System:-
Quality Risk Assessment
491 System:-
Quality Risk Assessment
492 System:-
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Verify whether all approved specifications are based
on validation.
—finished products
—finished products
—in process materials
—in process materials
—primary packaging materials
—primary packaging materials
—secondary packaging materials
—secondary packaging materials
—starting materials
—starting materials
—swab analysis
—swab analysis
—wash water analysis
—wash water analysis
—wash water analysis of cleaned garments
—wash water analysis of cleaned garments
—water analysis
—water analysis
How many products, process etc. have been
analysed for risk. Give brief.
Whether firm has policy document on QRM. Specify
document number and its effective date.
Whether risk priority number (RPN) is calculated
based on severity, probability and detectability. If
so, what is the criteria of acceptance.
40

INSPECTION SECTION NAME
Quality Risk Assessment
493 System:-
Quality Risk Assessment
494 System:-
495 Raw Materials
496 Raw Materials
497 Raw Materials
498 Raw Materials
499 Raw Materials
500 Raw Materials
501 Raw Materials
502 Raw Materials
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether the firm has adopted QRM principle to
mitigate risk involved in pharmaceutical
development, manufacturing and distribution. If
yes specify which guidelines are followed in this
regard.
Which known principles have been adopted to
analyse risks e.g. FMEA, HAZOP, HACCP, FTA etc.
(a) designated name of the product and the internal
code reference, where applicable, and analytical
reference number;
(b) manufacturer’s name, address and batch
number;
(c) the status of the contents (e.g. quarantine, under
test,released,approved, rejected); and
(d) The manufacturing date, expiry date and re- test
date.
How damaged containers are identified recorded
and segregated
How the containers from which samples have been
drawn labelled.
How they are labelled and stored as per their status
– Under Test, Approved and Rejected
Please specify the procedures by which it is ensured
that the raw materials which has been released by
the Quality Control Department and which are
within their shelf life are going to be used in the
product.
41
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

Please specify the procedures followed for receiving

and processing of in-coming materials (Starting
503 Raw Materials materials and packing material). Verify the SOP.
504 Raw Materials Specify the norms of vendor qualification.
Whether all the containers of each batch of starting
505 Raw Materials materials sampled for identification test.
Whether each batch of a consignment is considered
506 Raw Materials for sampling, testing and release.
Whether first in / first out or first expiry principal
507 Raw Materials has been adopted.
Whether incoming materials are purchased from
508 Raw Materials approved vendors.
Whether labels of raw material in the storage area
509 Raw Materials have information like ;
Whether list of approved vendors is available to the
510 Raw Materials user.
Whether separate areas are provided for under test,
511 Raw Materials approved and rejected materials.
512 Reprocessing and Recoveries:- Verify the SOP for reprocessing.
Whether reprocessed batch is subjected to stability
513 Reprocessing and Recoveries:- evaluation.
Whether the recoveries are added into the
514 Reprocessing and Recoveries:- subsequent batches. If yes specify the procedures.
515 Sanitation Specify the cleaning procedure of critical areas.
516 Sanitation Specify the disinfectant used for hand sprays? Compliance Filtered 70% IPA
Specify the quality of water used for preparation of Compliance Purified Water
517 Sanitation sanitising solution.
Compliance Chemgene, HiClean.
518 Sanitation Specify the sanitizing agent/s used.

42
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

Specify the SOP followed for sanitisation of sterile N/A

519 Sanitation processing facilities and mention the SOP nos.

Specify whether any SOP exists for the purpose of

520 Sanitation fumigation if so mention the SOP nos.

Specify whether disinfectant solutions are filtered Prefiltered Solutions

through membrane into suitable sterile containers Compliance
are used
521 Sanitation or sterilized before use?

Specify whether employees carrying out the

sanitation of critical areas are specially trained for Compliance Trained
522 Sanitation this purpose.

Specify whether fumigation is carried out in critical Chemgene 1-2%,

areas. If yes, specify fumigating agent and its conc. Compliance
HiClean 20%
523 Sanitation used.

Specify whether particle monitoring in Grade A N/A

zones is undertaken for the full duration of critical
524 Sanitation processing including equipment assembly.

Specify whether particle monitoring in Grade B

zones is undertaken for the full duration of critical N/A
525 Sanitation processing.
Used on the Same
Specify whether the diluted disinfectants bear day, under supervision
‘use before’ labels based on microbiological Compliance
of QA &
establishment of their germicidal properties & verify Microbiologist
526 Sanitation the records
527 Sanitation Verify the training records. Compliance

43

INSPECTION SECTION NAME
528 Sanitation
Sanitation in manufacturing
529 area
Sanitation in manufacturing
530 area
Sanitation in manufacturing
531 area
Sanitation in manufacturing
532 area
Sanitation in manufacturing
533 area
Sanitation in manufacturing
534 area
Sanitation in manufacturing
535 area
Sanitation in manufacturing
536 area
537 Security Arrangements
538 Security Arrangements
539 Security Arrangements
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether more than one sanitizing agent is used in Chemgene & HiCLean,
rotation. If yes list the sanitizing agents their Compliance
Monthly Rotation
concentration and frequency.
Does the location facilitate cleaning of equipment
as well as the cleaning of the areas in which they
are installed?
Mentioned in
Mention lux levels observed in production, visual Compliance
Qualification Protocol
inspection and other areas.
Specify in detail the procedure followed during
product changeover.
Specify the cleaning procedure of the
manufacturing areas and verify with the SOP in this
regard.
Verify the SOP & the records in this regard.
Whether a routine sanitation program is in place.
Whether cleaning procedure is validated.
Compliance
Whether production area is adequately lit.
Is CCTV available to control the Entry & Exit from
Factory premises?
Is the men & material movement inside the factory
premises, observed & checked through security
system.
Is there a system for identifying persons visiting the
factory ? How?
44

INSPECTION SECTION NAME
540 Security Arrangements
541 Site Master File:-
542 Site Master File:-
543 Site Master File:-
544 Site Master File:-
545 Stability Studies
546 Stability Studies
547 Stability Studies
548 Stability Studies
549 Stability Studies
550 Stability Studies
551 Stability Studies
552 Stability Studies
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
What is the precautionary activity taken for the
movement of carriers i.e. vehicles?
Verify whether all information as per cGMP
Guidelines.
Verify whether all information as per WHO TRS 986
and PIC/S document.
Whether all the relevant information has been
included in the site master file with no false claim or
data.
Whether quality policy has been included in the site
master file.
Specify the Temperature and humidity for real times
studies carried out for fixing shelf life of drug in the
country.
Specify the testing schedule for each product
Specify the validation method for stability chambers
Specify whether a complete description of stability
study is available.
Specify whether a written programme for ongoing
stability determination is in place.
Specify whether shelf life of the product is fixed on
the basis of stability studies.
Specify whether stability study is carried out in the
QC and if so, is there separate area for Stability
Chamber for stability studies. How many Stability
Chambers have been provided?
Specify whether stability study is performed after
any significant changes in process equipment,
packaging materials etc.
45

INSPECTION SECTION NAME
553 Stability Studies
554 Stability Studies
555 Stability Studies
556 Stability Studies
Standard Operating Procedure
557 and Records: -
Standard Operating Procedure
558 and Records: -
Standard Operating Procedure
559 and Records: -
Standard Operating Procedure Verify the List of SOPs and mention total number of
560 and Records: -
561 Sterilization
562 Sterilization
563 Sterilization
564 Sterilization
565 Sterilization
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify whether summary of all generated data
from the study are retained.
Specify whether the stability protocol indicates
complete set of testing parameters and methods.
Verify the qualification documents of all the stability
chambers.
Verify the stability calendar along with stability
protocol and documents. Attach the copy of
stability calendar
Has all the SOPs been displayed.
Is any obsolete copy seen in the Area?
The formats, logs & SOPs are current
SOPs followed by the firm.
Indicator (in case it has passed through sterilization
process)
Verify that the probe is placed at the coolest point
on the basis of validation studies
Verify the qualification, protocol and reports for the
sterilisers
Whether a clear means of differentiating
‘sterilized’ from ‘unsterilized‘ products
is in place. Specify.
Whether biological indicators used in monitoring of
sterilization.
46

INSPECTION SECTION NAME
566 Sterilization
567 Sterilization
568 Sterilization
569 Sterilization
570 Sterilization
571 Sterilization
572 Sterilization
573 Sterilization
574 Sterilization
575 Sterilization (By Dry Heat)
576 Sterilization (By Dry Heat)
577 Sterilization (By Dry Heat)
578 Sterilization (By Dry Heat)
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether sterilization records including
thermographs and sterilization monitoring slips
attached with the Batch Production Record
Whether the biological indicators stored and used
as per manufacturers instructions. Whether quality
of BI’s checked by positive controls.
Whether the label on the basket / tray or other
carrier of product / component clearly states:
Whether the sterilizing processes have been
validated (Dry heat, Moist heat, filtration, ETO,
ionizations whichever applicable.
Whether the terminal sterilizer’s capacity is
sufficient to sterilize one batch completely at one
time. If not specify controls and measures taken in
lot sterilizations.
Whether the validity of the process verified at
regular intervals (at least annually)
• Its batch number
• Its sterilization status
• Name of the material
1 Air circulation facility within the chambers
2 Positive pressure to prevent entry of non-sterile
air
Are adequate precautions taken to protect the load
during cooling after it has gone through the high
temperature phase of a heat sterilization cycle
If so, has the validation been done with challenge
tests using endo-toxins
47

INSPECTION SECTION NAME
579 Sterilization (By Dry Heat)
580 Sterilization (By Dry Heat)
581 Sterilization (By Dry Heat)
582 Sterilization (By Dry Heat)
583 Sterilization (By Dry Heat)
584 Sterilization (By Dry Heat)
585 Sterilization (By Dry Heat)
586 Sterilization (By Dry Heat)
587 Sterilization (By Dry Heat)
588 Sterilization (By Dry Heat)
589 Sterilization (By Moist Heat)
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
In case the cooling is affected with any fluid or gas
in contact with the product , is it sterilized.
In the process of sterilization by dry heat, does the
equipment have:
Verify the sterilizer loading pattern & whether is
complied with the validated loading pattern.
Whether sterilization cycle validated only by
biological indicator and chemical indicators or
physical validation is also carried out
Whether the chart forms a part of the batch record.
Whether the equipment air inlet and outlets been
provided with bacteria retaining filters
Whether the position of temperature probes used
for controlling and / or recording determined during
validation and (where applicable) been checked
against a second independent temperature probe
located in the same position
Whether the process of dry heat sterilization
intended to remove the pyrogens
Whether the sterilization cycle recording device of
suitable size and precision provided in DHS./ Tunnel
Whether the time allowed reaching the required
temperature before commencing the measurement
of sterilizing time, separately determined for each
type of load.
Are frequent leak tests conducted on the chamber
of the autoclave on each day of operation.
48

INSPECTION SECTION NAME
590 Sterilization (By Moist Heat)
591 Sterilization (By Moist Heat)
592 Sterilization (By Moist Heat)
593 Sterilization (By Moist Heat)
594 Sterilization (By Moist Heat)
595 Sterilization (By Moist Heat)
596 Sterilization (By Moist Heat)
597 Sterilization (By Moist Heat)
598 Sterilization (By Moist Heat)
Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether all items to be sterilized (other than sealed
containers) are wrapped for sterilization.
Whether recording of both temperature and
pressure carried out to monitor the process
Whether the control instrumentation independent
of the monitoring instrumentation and recording
charts.
Whether the equipment has automated control and
monitoring system, if so, have these been validated
to ensure that critical process requirements are
met.
Whether the readings of the thermograph during
sterilization cycling are routinely checked by the
operator against the reading shown by the dial
thermometer fitted with autoclave.
Whether the steam used for sterilization is of
suitable quality and doesn’t contain additives at
a level which could cause contamination of the
product or equipment
Whether the sterilizer fitted with a drain at the
bottom of the chamber If so, does the record of
temperature at this position is recorded through out
the sterilizing period
Whether the system and cycle faults are recorded
inbuilt and also observed by the operator and
record maintained.
Whether the wrapping material allows removal of
air and penetration of steam ensuring contact with
the sterilizing agent at the required temperature for
required time
49
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Whether the wrapping prevent contamination after
599 Sterilization (By Moist Heat) sterilization
Verify the records of calibration of following
600 TOC Analyser parameters:
Partial Single Point
601 TOC Analyser —Calibration (Four point calibration) Compliance Calibration
602 TOC Analyser —System suitability: Compliance

Are all the persons associated with various

production activities properly trained as per
guidelines provided inDRAP . Verify the assessment
records of the training of few selected people who
are associated with critical operations and
603 Training procedure
Specify whether basic training on GMP is provided
to all personnel attached to production and quality
604 Training control activity at the time of induction.
Specify whether concept of QA and its importance is
605 Training part of training session.
Specify whether periodic on job training is
606 Training provided.
Specify whether specific training related to the job
duty are provided to all personnel at the time of
607 Training induction.
/ Summary, Data tables, Results, Conclusions,
Protocol reference, Revision and approval
608 Utilities signatures.
we don’t have
609 Utilities 1) Bulk preparations of liquid injections N/A injection setup
2) Final rinse of product containers for sterile
610 Utilities preparations. N/A

50
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
3) Final rinse of machine parts (for sterile
611 Utilities preparations) N/A
4) Preparation of disinfectant solutions for use in
612 Utilities critical areas (for sterile preparations.) N/A
613 Utilities Calibration gauges N/A
Ensure presence of burst disc and check of its
614 Utilities inetrity N/A

615 Utilities Ensure whether the vent filter is hydrophobic or not N/A
How bio burden in purified water & WFI are
controlled / reduced (Mention the SOP no. followed
616 Utilities in this regard). C 24 hour circulation
How water tanks are cleaned periodically and
617 Utilities records maintained thereof. C Hot water sanitization
618 Utilities Limits across filters , carbon filter , flow rates etc.. N/A

Phase 1: Whether the operations parameters,

cleaning and sanitation procedures & frequencies
defined. Whether daily sampling records for every
pre-treatment point and usage point for a period of
619 Utilities 2 to 4 weeks maintained and SOP’s prepared. C PWP qulaified

PHASE 2: Whether daily sampling records for every

pre-treatment point and usage point for a period of
4 to 5 weeks after Phase 1 maintained and
620 Utilities reviewed. C PW qualification

PHASE 3: Whether weekly sampling records

621 Utilities available of every usage point for a one-year period. C PW qualification

51
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

Please check similarity of schematic diagram of the

622 Utilities water system and actual the water treatment plant C
Please specify whether Phase 1, Phase 2 and Phase
623 Utilities 3 studies carried as part of PQ stages? C
624 Utilities Presence of Trend analysis C
625 Utilities Preventive maintenance C
Specify how the circulation loop is sanitised. Verify
626 Utilities the SOP. C Hot water sanitization

Specify source of raw water and give details of

treatment processes, sampling points, distribution
and storage system for raw and purified water.
Verify whether the Raw Water holding tank was
627 Utilities sanitised as per specified SOP. C
Specify the arrangement for preparation of pure
628 Utilities steam & its use. C
Specify the MOC (Material of Construction) of the
water storage tank (Both PW & WFI) and its pipe
629 Utilities line. C SS 316
Specify the process of sanitisation of SS storage tank
630 Utilities of WFI. N/A
Specify the system in place for the compressed Dalgakiran Air Comp
631 Utilities gases / air used in the facility. C 160KW
Specify weather storage tank for WFI is steam
632 Utilities jacketed. N/A
Specify whether the quality of WFI meets the
633 Utilities requirement of BP/USP & cGMP. N/A
Specify whether action and alert limits are followed
based on qualification of water and compressed Air Compressed air tank
634 Utilities system. C and boiler

52
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify whether on line TOC test is available for WFI
635 Utilities & PW. N/A
Specify whether pressure release valves are
636 Utilities provided in the storage vessel. N/A

Specify whether pure steam (condensate) used in

production meets the microbiological specification
of not more than 10 cfu/100ml and BP/USP
637 Utilities specifications of WFI. N/A
Specify whether replacement of Air Vent filters on
the purified/WFI water tank is carried out as per
638 Utilities relevant SOP. N/A
Specify whether spray ball is used to wet the
surface of head space in the storage vessel of
639 Utilities PW /WFI tank N/A

Specify whether the quality of potable water used

for the preparation of purified water meets the
requirement of GMP in respect of microbiological
640 Utilities limit. N/A
Specify whether the quality of Purified Water used
for the preparation of WFI meets the requirement
641 Utilities of BP/USP. N/A

Specify whether water system

validation/qualification has been carried out as per
protocol and reports have been prepared and
642 Utilities maintained. C PW qualified
Specify whether WFI has been stored and circulated
643 Utilities above 70 degree centigrade. N/A
644 Utilities Specify whether WFI is used for: N/A
645 Utilities Verify PQ of the Pure Steam Generator.

53
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Verify the Dead leg of non returned valve at the
646 Utilities discharge point. C
Verify the qualification documents of compressed
air system specially where it comes in contact with
647 Utilities product or primary container. N/A
Verify whether a current drawing of the water
system showing all equipment in the system from
648 Utilities inlet to the points of use is available. C
Verify whether the softener column is regenerated
649 Utilities as per the specified SOP. C
What is the process for preparation of Water for
650 Utilities Injection (WFI)? N/A

Whether IQ protocol include at least facility review,

equipment specification vs. design, welding
roughness testing on pipelines, absence of dead
points / section in the pipelines, pipe and tank
passivation, drawings, SOP for operations, cleaning,
sanitation, maintenance and calibration of gadgets.
651 Utilities Whether its report includes Conclusion C

Whether OQ protocol includes at least System

production capacity (L/min), Flow type and water
rate, Valve operation, Alarm system operation and
Controls operation? Whether its report includes
Conclusion / Summary, operations performed Data
tables, Results, Conclusions, Protocol reference,
652 Utilities Revision and approval signatures. C 500 litre/hour
Whether the provision to keep dry the vent filter is
653 Utilities made. C yes
Verify the records of calibration of following
654 UV-VIS parameters:

54
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
—Calibration of absorbance reproducibility for
655 UV-VIS visible wavelength
656 UV-VIS —Calibration of Visible Wavelength
657 UV-VIS —CELLS Verification

658 UV-VIS —Control of absorbance (Photometric accuracy)

659 UV-VIS —Control of wavelengths (Wavelength accuracy)

660 UV-VIS —I0 flatness
661 UV-VIS —Limit Of Stray Light
662 UV-VIS —Photometric linearity at 430nm

663 UV-VIS —Resolution (second order derivative spectrum)

664 UV-VIS —Resolution Power
Are criteria established to assess the changes
665 Validation originating a revalidation?
Are the validation studies performed according to
666 Validation pre-defined protocols?
Are trend analyses performed to assess the need to
re-validate in order to assure the processes and
667 Validation procedures continue to obtain the desired results?
Identify the systems and processes to be validated
668 Validation as per VMP
In case electronic data processing systems are used,
669 Validation are these validated?
Is a written report summarized, results and
670 Validation conclusions prepared and maintained?

Is the validity of the critical processes and

671 Validation procedures established based on a validation study?

55
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

Please specify whether periodical challenge tests

672 Validation performed on the system to verify reliability.
673 Validation Specify the validation policy of the company

Specify whether key approval criteria are

mentioned in the VMP & how record and conclusion
of such validation studies are prepared and
674 Validation maintained.

Specify whether the critical processes validated

675 Validation Prospectively, retrospectively or concurrently.
Validation list for facilities/equipment, processes /
676 Validation procedure and products.

Verify Protocol format for each validation activity,

including re-validation and reasonable unforeseen
events (power failures, system crash and recovery,
677 Validation filter integrity failure.
Verify resources and those responsible for its
678 Validation implementation.

Verify whether documentation, standard operating

procedures (SOPs), Work Instructions and Standards
(applicable for national and international) are
679 Validation incorporated in VMP
Whether a Validation Master Plan has been
680 Validation prepared.

681 Validation Whether validation calendar is specified in VMP.

56
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Examine the record of the daily check of balances in
682 Warehouse the dispensing area.
683 Warehouse How access to quarantined area is restricted.
How containers are cleaned before and after
684 Warehouse dispensing. Who carries out the dispensing?

How containers are cleaned before and after

sampling. (Specify whether the sampling is carried
685 Warehouse out as per the current SOP).

How highly hazardous, poisonous and explosive

materials, narcotics, and psychotropic drugs are
handled and stored. How these areas are safe and
686 Warehouse secure.
How incoming materials are treated and cleaned
687 Warehouse before entry into the plant.
How labels, cartons, boxes, circulars, inserts and
688 Warehouse leaflets are controlled. ?

How printed packaging materials, product leaflets

etc. are stored separately to avoid chances of mix-
689 Warehouse up?

How printed secondary packaging materials are

690 Warehouse stored in safe, separate and in secure manner.
How quarantined materials are segregated from
691 Warehouse other materials.
How records of receipt of all labelling and packaging
692 Warehouse materials are maintained.

How returned/unused packaging material like foils

is controlled so as to prevent contamination and
693 Warehouse cross- contamination.

57
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

How the warehousing areas being maintained to

have good storage conditions. Are they clean and
dry and maintained within specified temperature
694 Warehouse and Relative humidity limits?
Is access to the area restricted to authorised
695 Warehouse personnel only.
Is cold room or deep freezers required for storage of
696 Warehouse goods?

Is there any SOP defining maximum exposure time

at room temperature for thermo labile materials i.e.
697 Warehouse prior to storage in a refrigerator.

698 Warehouse Please specify the cleaning system for the outer
Please specify the total area provided for
699 Warehouse warehousing.
700 Warehouse Specify sampling plan used.
Specify the arrangement provided for dispensing of
701 Warehouse starting materials.

Specify the arrangements provided to sample the

primary packaging materials foils, bottles, etc. which
702 Warehouse are used as such.
703 Warehouse Specify the pressure differential maintained.

Specify the storage arrangement provided for

materials which are sensitive to temperature,
humidity and light and how the parameters are
704 Warehouse monitored.
Specify the storage arrangement provided for
705 Warehouse primary packaging materials.

58
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)
Specify the system followed for storing passed raw
706 Warehouse materials.

Specify whether appropriate air velocity is

maintained in sampling & dispensing areas which
rule out any influence in the balance readings
707 Warehouse placed inside the RLAFs Benches.

Specify whether dispensed material for each batch

of final product are kept together and conspicuously
708 Warehouse labelled.
Specify whether the dispensing is carried out as per
709 Warehouse the current SOP.
710 Warehouse surface of the container.

Temperature and relative humidity mapping of the

warehouse considering all seasons and worst case
711 Warehouse scenarios
Verify the Temperature mapping of the cold rooms
712 Warehouse or deep freezers

What is the control on entry of material and men

into the dispensing area? Whether reverse LAF have
been provided for dispensing with back ground
713 Warehouse clean air supply.

What is the control on entry of material and men

into the sampling area? Whether reverse LAF have
been provided for sampling. Whether log book for
714 Warehouse sampling booth maintained.

59
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

What provisions have been made for segregated

storage of rejected, recalled or returned materials
or products. How is the access to these areas
715 Warehouse restricted?
What steps are taken against spillage, breakage and
716 Warehouse leakage of containers?

Whether adequate areas have been allocated for

warehousing of Raw Materials, intermediates,
Packaging Material, products in quarantine, finish
products, rejected or returned products. How are
717 Warehouse these areas marked or segregated.
Whether pressure differential is maintained
718 Warehouse between the dispensing and adjacent areas.
Whether proper racks, bins and platforms have
719 Warehouse been provided for the storage.

Whether receiving and dispatch bays are

maintained to protect in coming and out going
720 Warehouse materials.
Whether unused packaging materials return to the
721 Warehouse store or destroyed.
Which type of sampling tools are used and how they
722 Warehouse are cleaned, dried and maintained.
Mention the procedure for storage and disposal of
723 Waste Disposal rejected drugs and applicable SOP.

60
 Category of
Compliance Observation(Cri
status (C, PC, tical, Major,
INSPECTION SECTION NAME INSPECTION CHECKLIST QUESTIONS NC, N/A) Short Description Minor)

Specify the system of disposal of sewage, and

effluents (solid, liquid, and gas) from the
manufacturing site.(Enclosed the copy of NOC
obtained from State Pollution control board in this
724 Waste Disposal regard.)
Whether adequate records are maintained for the
725 Waste Disposal disposal of waste.

Whether provision for disposal of bio-medical waste

726 Waste Disposal made as per the provisions of the relevant laws.

61