TITLE: Site Master File

Document No. EFFECTIVE DATE NEXT REVIEW DATE PAGE No.

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SITE MASTER FILE

OF

SOLITAIRE PHARMACIA PVT.LTD.

PLOT NO.25 Ext -1 HPSIDC AREA BADDI DISTT
SOLAN HIMACHAL PRADESH-173205

Dosage Forms : Tablets (General & Hormonal )

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 TITLE: Index
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Sr.No Title Page No.

1 Cover Page 01
2 Index 02
3 General Detail 03
4 Plant Location 04&05
5 General Information 06&07
6 Process Approach 08&09
7 Personal 10 To 12
8 Premises 13 To 15
9 Ventilation system & Utilities 16 To 19
10 Equipments 20 To 25
11 Sanitation & Documentation 26 & 27
12 Production 28 & 29
13 Quality Control 30 To 32
14 Distribution, Complaints and Product Recall 33
15 Self Inspection 34
16 Quality policy 35
REVISION INDEX

Sr. Date Document Change Details Checked

No. No. By

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 TITLE: General Detail
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General Detail

3.1 Type of Industries : Pharmaceuticals Industry.

3.2 Name of Dosage Forms : General Tablet, Hormonal Tablet

3.3 Works (Factory) : Solitaire Pharmacia Pvt.Ltd

Plot No. 25 Ext-1 HPSIDC Area,
Baddi, Tehsil Nalagarh ,
Dist solan.(H.P) -173 205.
Tel.: 09815777744
E-mail : radixbiotech@rediffmail.com
: radixbiotech@yahoo.com

3.4 Marketing Office : Solitaire Pharmacia Pvt.Ltd

PLOT NO. 73,INDUSTRIAL AREA,
PHASE II, CHANDIGARH.

Tel.: 0172-5000477,5000478
Fax:5000477,2653293

3.5 Contact Persons : Mr. Sanjeev Kumar Sethi (Managing Director)

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 TITLE: Site Location Plan
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A
M
Annexure:4.1
A
R
A
Road No. 3 V
A
T
SOLITAIRE
PHARMACIA
Plot no.19 PVT. LTD. Plot no. I
Plot no.25
Plot no26. Plot no.

R
Plot no. O
Plot no.18 Plot no 27 A
D
Plot no.28 Plot no.

Plot no.29 Plot no.

Road Road Road

Spray Eng.

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 TITLE: Site Location Plan
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DRAW SCATCH OF PLANT LOCATION FROM RAILWAY STATION

Amaravati
Appt. N.R.I KALKA
Hospital RAILWAY

SHIMLA
STATION

Solitaire
Pharmacia
Pvt. Ltd.

BADDI
BUS STOP BADDI PINJOR
NALAGARH

CHA NDIGARH

Annexure:4.2

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5.0 GENERAL INFORMATION

INTRODUCTION:
SOLITAIRE PHARMACIA PVT LTD., a Baddi (H.P.) based company established by Mr.Sanjeev
Kumar Sethi, who has deep knowledge and vast experience of pharmaceutical business .He has
now ventured in setting up state of the art pharma manufacturing facility of WHO,cGMP
standards.

LOCATION :-

The plant is located at Baddi (Himachal Pradesh) in well connected industrial belt at a distance of
40 kms from Chandigarh on Pinjore – Nalagarh Highway and is engaged in the manufacturing of
solid dosage forms. The location is well connected with roads & railway station is about 20 kms at
Kalka.
The plant is located on 997 square meter plot. The factory is constructed and designed to meet the
WHO, cGMP standards in consultation with highly qualified and experienced technical
personnel’s approved by FDA for manufacturing and testing. The plant has AHU systems i.e., Air
conditioning and Control humidity for all manufacturing departments to avoid cross
contamination.
Solitaire Pharmacia Pvt. Ltd has established a modern facility as per GMP standards to
manufacture tablets (Non ß-Lactam) & Hormonal tablets . The unit is managed by experienced
technical staff for production & quality control along with a team of expert technicians.
The company has a pharmaceutical formulation plant located on the Ground floor for hormonal
product & first floor for Non ß-Lactam respectively

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SALIENT FEATURES

SOLITAIRE PHARMACIA PVT LTD. has observed and will practice the following:-
Factory designed and constructed as per GMP specification.
Code of ethics in production and quality.
Training to the personnel as per new guidelines.
Electrification is done for easy energy audit.
Illumination level 300 lux in all manufacturing areas.
Water proofing of entire terrace slab.
HPLC. UV-spectrophotometer under one roof.
Pre-Construction Anti-Termite Pest Control treatment for entire factory building
The company has full fledged Quality Assurance, Purchase, Store, Production, Administration
Engineering Dept., headed by very experienced personnel’s.
All standard operating procedure (work instruction) related with above production process are
available with QA department & individual department.
Facilities & list of equipment are available in site master file.

List of Proposed products and other technical details are available in site master file.

Plant is fully equipped with:

5.1 Exhaustive pest control system to ensure total freedom from insects and rodents.
5.2 Wall, floor and ceiling painted, free from crack, dust and dirt.
5.3 Full Fledged water system i.e.(a) Raw water system equipped with sand filter to ensure
free from Insoluble and gaseous impurities (b) R.O water plant for Purified water
Core team of HOD’s of Quality assurance/Quality Control, Engineering, Production & Adm.
Working under Managing Director ensures effective quality system, planning and
Implementation.

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TYPE OF PRODUCTS LICENSED FOR MANUFACTURE WITH FLOWCHART

MENTIONING PROCEDURE AND PROCESS FLOW :
(i) Soltaire Pharmacia Pvt.Ltd manufactures wide range of pharmaceuticals formulations in
General Categories of General Tablet & Hormonal tablets as per the approved Product List
enclosed
(ii) For process flow & procedure flow chart as per following.
Tablets
Weighting Sieving Mixing Wet or dry Drying
Granulation

Q.A.-2 Q.A-1
Visual Inspection Compression Lubrication Sizing / Milling

Q.A. - 4

Coating Tablet packing

Q.A.-3

Visual Inspection Final Release

Q.A.- 4
Sampling --- Testing
Tablet packing
QA1 --- Water content, Bulk density
Q.A.- 5 QA2 --- Weight variation, Appearance, Colour
Shape, D.T, Hardness, Friability
Final Release QA3 --- D.T. Appearance
QA4 --- D.T, Appearance, Pathogen and
QA5 --- In process labeling, packing details
Dispatch

Annexure:6.1

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Solitaire Pharmacia Pvt.Ltd has facility to carry out Chemical Physico-chemical, Instrumental
Analysis
Solitaire Pharmacia Pvt.Ltd takes assistance from outside institution for testing its samples
Samples are sent for getting testing done where sophisticated instruments like IR, GC & Bio-
Assay are required.

.
PROCESS APPROACH: there will be basically four type of process in the organization
a. Core process (customer related process) Dispatch
b. Management process (process carried out by top management /MR)
c. Supporting process (process to help core /management process)
d. Work process (process flow as per individual department wise Customer
Satisfaction
Quality Policy &
Quality Objective Production
(Business Plan)
Marketing
Budgeting
(Resource Plan) Core
Management Management Process
Process Material / Production
Review / Audit / Service / testing
Customer
Order

Resource Production / Material service

Allotment Service procurement /
Planning storage

Annexure:6.1

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7.0 PERSONNEL
(a) ORGANISATIONAL CHART SHOWING THE ARRANGEMENTS FOR QUALITY ASSURANCE INCLUDING
PRODUCTION & QUALITY CONTROL :
HIERACHICAL CHART
Managing Director

Plant Head

Q.C In Charge Q.A In Charge / Production

Management In Charge
Representative

Engineering Store In Charge

In Charge

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(b) QUALIFICATION, EXPERIENCE & RESPONSIBILITIES OF KEY PERSONNEL :

Sr. Name of Person Qualification Experience Department Approval /

No. Unapproved
(A) MANUFACTURING SECTION
1 Mr. Rajesh B.Pharm 8 yrs Mfg. Section Approved
Makanwal
2 Mr Ram lal B.Sc. 18 yrs Mfg. Section Approved
Prajapati
(B) QUALITY CONTROL SECTION
3 Mrs. Jahanvi Rao M.Sc. 16 yrs Chemical and Approved
Physicochemical
Section

Number of employees to be engaged in production, quality control, storage and

distribution.
Production Dept. : 10
Quality control & Assurance Dept. : 06
Store ( RM, PM & FG) : 04
P & A Dept. : 03
Maintenance Dept. : 03
Account Dept. : 02
Total : 28

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(c) OUTLINE FOR ARRANGEMENT FOR BASIC AND IN SERVICE TRAINING AND HOW
RECORDS ARE MAINTAINED :

All employees will have to go through training as per annual training plan. Training on GMP will be
on-going process and all the employees will be regularly trained to increase their awareness of
current requirements. Immediate outside experts & superior impart through training for all
departmental. The employees are subjected to oral & written quarries. The training records will be
maintained for all employees.

(d) HEALTH REQUIREMENT FOR PERSONNEL ENGAGED IN PRODUCTION :

 Administrative head is responsible for arranging the medical checking of employees
through a qualified physician.
 Medical examination is carried out by company approved physician every year or in
between if required.
 For any unusual findings during the check up physician advises the person affected.
During the treatment period suitable reallocation of job is done. Rechecking is done
following approved guidance & frequently, and after the person is certified medically fit,
he is put on his original job.

(e) PERSONNEL HYGINE REQUIRMENTS, INCLUDING CLOTHING :

 The company provides change rooms for changing company uniforms including shoes.
 The employees working in production area change their shoes and wear factory
footwear, along with factory uniforms & cap.
 The employees in other areas like Quality control will wear aprons and laboratory
slippers. The employees in engineering department wear suitable shoes and factory
uniforms.
 All the employees have been instructed about dress code and to change the dress
every other day.
 Other aspects of personnel’s hygiene like daily bath, hair & nail cut.

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 TITLE: Premises
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8.0 PREMISES
(a) LAYOUT PLAN OR DESCRIPTION OF MANUFACUTRING AREA :

Sr. Area Type of area finishing

No.
1. Ground floor RCC Roof, Kota Stone & Flush doors.
2. First floor RCC Roof, Kota Stone & Flush doors.
3 Second floor Vetrified tiles in Q.C Area
4 Service Area RCC roofs & Covered with fancy hood
3. Utility Block RCC Floor
4. D.G.Set Area RCC Floor

Ground floor First floor Second floor

Sr. Area Sr. Area Sr. Area
No. No. No.
1. MD & Adm. Office 1. GeneralProduction 1. Incubator
2. Warehouse 2. General Packing 2. Chemical section
3. Change room 3. Approved R.M Store 3. Retain sample
4. Toilet 4. Approved P.M Store 4. Record room
5. R.M.Store 5. Stability chamber
6 HormonalProduction 6. Q.C.Office
7 Security office 7. Micro testing
8 Visitors Rooms 8. Media prepn Room
9 Hormonal Packing 9. Instrument Room
10 Utility Block
11 D.G & Pannel Area

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Canteen & toilet is not directly attached with production area. Plant layout design & equipment is
as per the revised schedule-M requirement.

(b) NATURE OF CONSTRUCTION & FIXTURES / FITTINGS :

 Building: The building is made up of RCC construction and all the processing areas
from inside are having smooth wall painted with oil paint/oil bound emulsion paint.
 Utility: Manufacturing equipments are provided power supply back up with DG set,
which is bale to restore DG power within 2 minutes. The critical QC instruments are also
provided with stabilizer.
 Aluminum doors & Windows: The doors and windows are designed very carefully to
have a minimum number of horizontal surfaces. The sills of the windows are sloping.
The windows are kept flush with the plaster inside manufacturing areas and gap
between aluminum and masonry are sealed with scaling.
 Floor: Flooring is made up of mirror polished Kota stone.
 Coving: Coving is provided in all production areas at the junction of wall to floor, wall to
wall to ceiling and are painted with washable paint.
 Fall ceiling: Fall ceiling in the air-conditioned areas is of plaster of paris sheets. The
sheets is fixed with double layered arrangement and the joints of the upper layer and
lower layer of the board are so arranged (staggered) that there is no leakages of air.
 All entrances and major doors are provided with air lock and air curtains wherever
required.
 The sanitary fittings are connected and drainage system is under ground and provided
with trapped gullies.
 S.S Light
 S.S-304 riser
 Both Side Stair & Well Equipped Lift provision

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(d) SPECIFIAL AREAS FOR THE HANDLING OF HIGHLY TOXIC, HAZARDOUS &
SENSITIZING MATERIALS:

Not Applicable, as presently we do not use such type of materials.

(e) BRIEF DESCRIPTION OF WATER SYSTEMS (schematic drawings of systems) :

Copy attached

Total 4 sampling points are provided for water system monitoring, cleaning, sanitation and
validation plan is followed as per standard operating procedures, water log book & water
validation file.

(f) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMMES FOR

PREMISES AND OF THE RECORDING SYSTEM :

More emphasis is given on the preventive maintenance program of plant utility services, machines
etc. Maintenance department is equipped with highly qualified and experienced engineers and
technicians. Maintenance as well as plant operators are provided through training at machine
manufacturing site for knowing its operation, use, accuracy, efficacy etc.

Installation qualification & performance qualification of every new machine is carried out.
Calibrations are done frequently. The logbooks are maintained for all critical equipments.

Whenever necessary, help of outside maintenance consultants is taken to maintain facilities such
as Air handling units, laminar air flow, pest control etc. routines as well as periodical maintenance
are scheduled and documented. For recording system computer validation system is followed.

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 TITLE:VENTILATION SYSTEM & UTILITIES
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SR. NO. DESCRIPTION

1 AIR HANDLING UNITS

HOREMON-Ground Floor
AHU-1-4000CFM-65mm- 8TR[Grenulation]
AHU-2-600CFM-65mm- 1.5 TR[Sampling/Dispensing]
AHU-3-600CFM-65mm- 1.5 TR[TIB]
AHU-4-1200CFM-65mm-3TR[Blister Pack]
AHU-5-800CFM-65mm-2TR[Strip Pack]
AHU-6-800CFM-65mm-2TR[Compression]
AHU-7-1200CFM-65mm- 3TR[Coating]
AHU-8-3200CFM-65mm- 6TR[Corridor & Misc.]
AHU-9-600CFM-65mm-1.5TR[Sampling]
AHU-10-800CFM-65mm- 2TR[Blending]
AHU-11-600CFM-65mm- 1.5TR[Sampling]

General Tablets-First Floor

AHU-12-4800CFM-65mm-10TR[Granulation]
AHU-13-1200CFM-65mm-3TR[Blending]
AHU-14-1200CFM-65mm- 3TR[Coating-1]
AHU-15-1200CFM-65mm- 3TR[Compression-1]

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 AHU-16-800CFM-65mm- 2TR[Compression-2]
AHU-17-600CFM-65mm- 1.5TR [TIB]
AHU-18-600CFM-65mm- 1.5TR[Dispensing]
AHU-19-1200CFM-65mm-3TR[Blister-1]
AHU-20-1200CFM-65mm-3TR[Blister-2]
AHU-21-800CFM-65mm- 2TR[Strip Packing]
AHU-22-3200CFM-65mm-6TR[Corridor & Misc.]
AHU-23-1200CFM-65mm- 3TR[Coating-2]

Quality Control-Second Floor

AHU-24-600CFM-65mm-1.5TR[ Micro Q.C.]

2 Forcd Draft Ventillation Supply Air System[GROUND FLOOR]

FDVS-1:2000-20[Gen.Ch.Room]
FDVS-2:1000-50[Hormon Ch.Room]
FDVS-3:1000-20[Hormon PMS]
FDVS-4:1000-20[General PMS]
FDVS-5:3000-20[Misc. Q.C.Area]

3 Forcd Draft Ventillation Exhaust Air System[GROUND FLOOR]

FDVE-1:1000-20[Gen.Ch.Room-First floor]
[Not Require as Room Exhaust-Hormon]
FDVE-3:1000-20[Hormon PMS]
FDVE-4:1000-20[General PMS]
[Not Require as Room Exhaust-Q.C]

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 4 Refrigeration Type Dehumidifire
1 TR
2 TR

OTHER UTILITIES[GROUND FLOOR]

5 Air Compressor-1
Air Compressor-2

6 Compressed Air Dryer

7 D.M Water Plant

8 D.M Water Plant

9 ETP

Split A.C Misc. Stores[GROUND FLOOR]

R.M.Approved Store
Horemone F.P.S
Secondary Packing Hall
General FP Stores
Director's Office
Reception

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 Manager Office
Staff Office

Split RM Stores[FIRST FLOOR]

A.C Approved RM[14a]
ALU.PVC Store[14b]

Split A.C Misc. Areas[SECOND FLOOR]

Q.C.Manager
Critical Instrument Room
General Instrument Room
Retain Sample Room

Minimum 20 air changes are provided in all production area, supply filter are having 5  porosity & return filter are
having 20  porosity. Minimum 0.5mm pressure difference is kept in different categories of production area with
maximum positive pressure kept in filling & sealing area. Refer plan layout Annexure 1 for more details.

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 TITLE: Equipment
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4.0 EQUIPMENT

(a) BRIEF DESCRIPTION OF MAJOR EQIPMENT USED IN PRODUCTION & CONTROL

LABORATORIES :

General Tablets

NAME OF SUPPLIER CAPACITY ELE. AIR

MACHINE LOAD QTY(CFM) PRESSURE(K
H.P G)

FLUID BED TECHX 60 KG 14.0 100 6.0 kg

DRIER
VIBRO SIFTER TECHX 36” 1.0
R.M.G TECHX 150 LTR 28.0 10 6.0 kg
PASTE KETTLE TECHX 100 LTR 5.0
MULTIMILL TECHX 250 KG/HR 3.0
LUBRICATION
OCTAGONAL TECHX 300 LTR 3.0
BLENDER
COATING-1
COATING PAN TECHX 36” 7.0
SOLUTION TECHX 50 LTR 0.7
PREPARATION
TANK
COLLOID MILL TECHX 3.0
COATING-2
COATING PAN TECHX 36” 7.0
COMPRESSION
ACRA-B4-27-D FLUIDPACK 27 STN (D – 5 .0
TOOLING)
ACRA-B4-27-D FLUIDPACK 27 STN (D – 5 .0
TOOLING)
DUST FLUIDPACK 150 CFM 1.50 150
EXTRACTOR-1

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DUST FLUIDPACK 150 CFM 1.50 150
EXTRACTOT-2
DE- F.P 2.0
BURRING&DED MACHINERIES
USTING UNIT 4
NO.
PACKING
BLISTER KULBINDRA 9.0 150 6.0 kg
ALU-ALU P.G 9.0 150 5.0 kg
CONVEYOR 1.0
BELT-1
CONVEYOR 1.0
BELT-2

HORMONAL SECTION
GRANULATION SECTION
FLUID BED TECHX 10 KG 8.0
DRIER
VIBRO SIFTER TECHX 12” 0.5
R.M.G TECHX 25 LTR 5.0
MULTIMILL TECHX 2.0
LUBRICATION
OCTAGONAL TECHX 50 LTR 1.5
BLENDER
COATING-1
COATING PAN TECHX 24” 5.0
SOLUTION TECHX 50 LTR 0.7
PREPARATION
TANK
COMPRESSION
ACRA-B4-27-D FLUIDPACK 27 STN (D 5.0
–
TOOLING
DE- F.P 1.0
BURRING&DED MACHINERIES
USTING UNIT 4
NO.
DUST FLUIDPACK 150 CFM
EXTRACTOR-1
PACKING
BLISTER KULBINDRA 8.80 150 4.0 kg
STRIP KULBINDRA 3.5
CONVEYOR 1.0
BELT-1
CONVEYOR 1.0
BELT-2
D.G. SET SUDHIR GENSET 200 KVA

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AIR KAILA ENGIN 10.0
COMPRESSOR
AIR DRIER KAILA ENGIN 2.0
R.O.PLANT ARYATECH 1000 7.0
LTR/HR
E.T.P PLANT MAINSA ENGG. 3000-5000 7.0
WORKS LTR
A.H.U DYNAFLOW 250.0

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 TITLE: Equipment
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SR.NO. NAME MAKE MODEL NO, SPECIFICATION

1 HPLC Waters 515 Isocratic system
2 UV spectrophotometer Shimadzu UV-1800 Std.
3 Analytical Balance
4 pH meter
5 Abbe refractometer
6 Polarimeter
7 KF apparatus
8 UV cabinet
9 Melting point apparatus(digital)
10 Potentiometer/Autotitrator

CHEMICAL SECTION
NAME OF LABORATORY
SR.NO. INSTR. MAKE MODEL NO, SPECIFICATION
1 Vaccum oven
2 Sonicator
3 Mechanical flak shaker
4 Water bath
5 Universal oven
6 Muffle furnace
7 Heating mantle
8 Hot plate with stirrer
Dist. Water app. (wall
9 mounted)s.s
10 TLC kit
11 Bulk density appa.(Tapping type)
12 Dissolution test appa. 8 baskets
13 Leak test appa.
Friability appa.(digital rpm
14 counter)
15 Hardness tester
16 IR moisture balance
17 Centrifuge machine
18 Vortex mixer

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 NAME OF LABORATORY
SR.NO. INSTR. MAKE MODEL NO, SPECIFICATION
1 Microscope
2 Autoclave
3 Bacteriological incubator
4 BOD incubator
5 Colony counter(digital)
6 Laminar Air Flow bench Popular Horizontal

(b) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMS FOR

EQUIPMENT & OF THE RECORDING SYSTEM :

As mentioned in point planned preventive maintenance exists and the records are maintained for
preventive maintenance and major breakdown of equipment and machine.

(c) QUALIFICATION & CALIBRATION INCLUDING THE RECORDING SYSTEM AND

ARRANGEMENT FOR COMPUTERIZED SYSTEMS VALIDATION :

Periodic calibration / validation of equipments / process / Utilities / system / personnel are carried
out and records are maintained. For certain equipments and utilities validation is carried out
periodically by the standard external agencies. Calibration / validation schedule protocol is as per
calibration / validation Index .
It is audited in self-inspection.

Written standard operating procedures are laid for cleaning of manufacturing areas and
equipments. For area cleaning two type disinfectants are used fortnightly alternatively. Review of
standard operating procedure is made at every three years and any correction / deviation is
properly recorded after getting authorization from Q.A. as per procedure of document & data
control.

Pest control of the entire plant is maintained through administration department with the help of
outside agencies.

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List of Calibration of Equipments / Instruments

Sr.No. Item Frequency of Calibration/

Validation
1 Pest Control Yearly
2 Medical Checkup of Employee Yearly
3 Aseptic Filling (Media Fill test) Yearly
4 Filter Integrity Testing Batch wise
5 Manufacturing tank At the time of purchase
6 pH Meter Daily
7 Single Pan Balance Daily/ Yearly
8 Plate form Balance Daily/ Yearly
9 Spectrophotometer Monthly
10 Auto clave Daily/Quarterly
11 Dry heat sterilizer Daily/Quarterly
12 Aseptic Area Daily
13 U.V. Light Quarterly
14 Thermometer At the time of use
15 Glass equipment At the time of purchase
16 Normality Testing At the time of use
17 Pressure/Temp.gauges/Hygrometer Yearly
18 Hepa filters Yearly
19 Product Stability studies As per individual product
20 Inter Department Audit Quarterly
21 Melting point Apparatus Monthly
22 Karl Fischer apparatus At the time of use

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 TITLE: Sanitation / Documentation
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11.0 SANITATION
(a) AVAILABILITY OF WRITTEN SPECIFICATION & PROCEDURE FOR CLEANING
MANUFACTURING AREA & EQUIPMENT :
Sanitation of entire plant, surrounding and manufacturing area is being done as per area cleaning
SOP’s
Efficacy of Disinfectant solutions is validated microbiologically.
HVAC system & water system is also continuously sanitized and the same is recorded in utility
logbook.
Validation of the equipment cleaning will be done as per master validation plan.
11.A DOCUMENTATION
(a) ARRANGEMENT FOR THE PREPARATION, REVISION & DISTRIBUTION OF
NECESSARY DOCUMENTATION FOR MANUFACTURE:
a. Well-defined system exists for in warding, storage and issue of raw & packing
materials.
b. Raw & packing materials are sampled and approved by Quality Control department.
c. Batch manufacturing records (BMR) for every product and every batch is issued by
quality assurance to production department.
d. In process checks at regular intervals are carried out with proper documentation by Q.A.
e. All manufacturing operation is followed as per instructions given in BMR and entail
heads before submission to Q.A. for final approval of the batch.
f. Before final dispatch of every batch, Quality assurance department verifies BMR along
with certificate of analysis and release slip is issued.
Solitaire Pharmacia Pvt. Ltd. maintains documents regarding:
 Standard Operating Procedure & its related records.
 Site Master file
 Specification of all Materials & Finish products
 Test procedure & protocol
 Master formula card
 Batch production & control records
 Disposal records
 Release records & distribution records
 Calibration / Validation records
 Quality management system related documents

Management representative Q.A.Incharge Managing Director

Prepared by Checked by Approved by
 TITLE: SANITATION & Documentation
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Standard operating procedure are prepared for each and every operation and are authorized
for all the departmental activities and strictly followed.

All minor changes in the documents are recorded in the same records by recalling copies from
all departments for authorization by QA head with date of correction. For major changes entire
documents are replaced with amendment copy and old copies are destroyed except one kept
with QA department with cancellation.

A detail of documents withdrawal / distribution will be kept with QA department under

document and data control index.

Necessary document related to manufacturing such as Master formula card and Batch
manufacturing & its associated record are maintained and issued by Q.A.department.

(b) ANY COPY OTHER DOCUMENTS RELATED TO PRODUCT QUALITY THAT IS NOT
MENTIONED ELSEWHERE :
(E.G. MICROBIOLOGICAL CONTROLS IN AIR & WATER)

Following methods are followed as per well-defined schedule:

 Microbial counts and limit tests for bore well, DM water and finished products.
 Manufacturing, filing & sealing areas environmental monitoring by setting plat count.

Management representative Q.A.Incharge Managing Director

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 TITLE: Production
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7.0 PRODUCTION
(a) BRIEF DESCRIPTION OF PRODUCTION OPERATIONS :

Production operation is explained by way of flow chart describing movement of material &
movement of batch manufacturing record. Refer Annexure 6.1 attached.

(b) ARRANGEMENTS FOR THE HANDLING OF STARTING OF STARTING

MATERIALS, PACKAGING MATERIALS & BULK & FINISHED PRODUCTS INCLUDING
SAMPLING, QUARANTINE, RELEASE & STORAGE :

Each consignment of material received is examined visually and damaged goods are kept
separate and inform to quality control person for further instructions for disposal or return goods to
party.

On verification of quantity received and making batch wise segregation identification number is
given serially.

All the containers are labeled “UNDER TEST” with details such as name, inward number, quantity,
no. of containers, manufacture’s name, material code no. and put material in to the quarantine
area.

Samples are drawn as per sampling plan & tested in detail as per specification by quality control.
On completion of tests Q.C. decided whether the material is approved or rejected and accordingly
if material is approved, “APPROVED” label are fixed and material is transferred to approve
material storage area. If material rejected than transfer to rejected area (Flow chart of Movement
of material is enclosed).

All packing materials are stored securely under lock & key and issued in requisite number only. At
various places of operation separate areas are created so that the material or product is held on
“Under Test”, “Approved”, “Rejected” or “Quarantine” area etc. All raw materials are transported in
closed labeled containers or properly labeled sealed plastic bags. The Quality Assurance
instructions are followed for material status. All weighing balance are regularly calibrated.

Management representative Q.A.Incharge Managing Director

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 TITLE: Production
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(c) ARRANGEMENTS FOR THE HANDLING OF REJECTED MATERIALS & PRODUCTS :

For all rejected materials, the materials are separated from other “Approved” or “Under Test” lots
and “Rejected” labels are affixed by the Quality control persons. The rejected material is
transferred to a separate “Rejected materials” area. Quality assurance decides the fate of such
rejected materials as to destroy, reprocess or to refer to the supplier.

(d) BRIEF DESCRIPTION OF GENERAL POLICY FOR PROCESS VALIDATION :

Process validation is as per documented program (master validation plan), which provides a high
degree of assurance that a specific process will consistently produce a product meeting it’s
predetermined specification and quality attributes.

We follow the following systems with regard to process validation:

 Establish specification and performance criteria.

 Select methodology, process & equipment to ensure the product meets with the
specification.
 Test the final product using validated analytical methods in order to meet specification.

Following steps supports the above steps:

 Calibration, verification and maintenance of process equipments.

 Qualification of both process & equipment.
 Challenge, audit, monitor or sample the recognized critical or key steps in the process.
 And finally when there is a significant change in the product or process,
Re-qualify or revalidate the process.

Management representative Q.A.Incharge Managing Director

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 TITLE: Quality Control
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SHORT DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM OF THE FIRM

The company believes in total quality management system and constantly upgrading standards of
specification of its products & services. The quality policy states as under,

We at Solitaire Pharmacia Pvt Ltd are Committed,

To supply Quality medicines at competitive rates & Service to

Satisfy our Customer.

To follow prevailing National & International Standards of Pharmaceutical

Industry.

To continually improve our Quality Management System with Continual

Training & Collective Wisdom.

Management representative Q.A.Incharge Managing Director

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 TITLE: Quality Control
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Quality has been the most prime consideration in recruitment of manpower. Our organization chart
explains the hierarchical levels of the organization.
For strengthening the system, following activities are carried out by Pharma consultants.
 The in-house training programme covers all relevant aspects of cGMP.
 Testing as per well defined specification control the input materials and release
procedures for semi finished and finished products exit. Production as well as Quality
assurance monitors quality by carrying out in process testing during various stages of
manufacturing.
 Standard operating procedures are available for different operations. Products are
manufactured as per procedure given in batch manufacturing records and recorded
accordingly.
 Standard validation/calibration protocols adhered for validation of all critical equipments
processes/instruments/products/system/utilities etc.
 Master formula records, which are prepared for individual products, are adhered in
batch manufacturing & testing processes.
 Maintenance history records are maintained for critical instruments and equipments to
ensure proper preventive maintenance.
 The assessment of effectiveness of QMS is done by periodic self-inspection &
management review meeting.
a. Incoming material Quality
b. Product Quality
c. Compliance with systems / document control
d. Customer complaints
e. Corrective action to avoid non-conformity
f. Internal Quality Audits

Management representative Q.A.Incharge Managing Director

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 TITLE: Quality Control
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QUALITY CONTROL
(a) DESCRIPTION OF QUALITY CONTROL SYSTEM AND OF THE ACTIVITES OF THE
QUALITY CONTROL / QUALITY ASSURANCE DEPARTMENT PROCEDURE FOR THE
RELEASE OF THE FINISHED PRODUCTS :

Quality assurance & Quality control department combines activities performed are as follows.
 Specification of raw material, Packing material & Finished products are prepared,
standardized & pharmacopoeia guidelines are followed for the same. Outside help is
procured for developing in-house specification in area where pharmacopiea
specifications do not exist.
 Methods for reagent standardization and instrument calibration / validation are defined
and being followed.
 Procedure for the release of raw material and finished products are defined and being
followed as per the standard procedure and the norms down in pharmacopiea or by
developing in-house specification.
 Company is having well-equipped Quality control laboratory having Physico-chemical
instrumentation and microbial testing. Laboratory facilities with necessary retain sample
and documentation storage area. All well define procedures for finished product
analysis are followed and finished product release for the market after complete testing.
 The store dispenses the materials in presence of Q.A. person against bill of materials
issued. The dispensed materials carry appropriate labeling.
 Manufacturing activities are started as per Batch manufacturing record.
 In-process checks are carried out by production and Q.A. independently.
 Coded packing materials are checked by production and Q.A. for the correctness of
batch coding details.
 The packing department reconciles the printed packing materials.
 Batch production records are reviewed by production and Q.A. and yield data are
reconciled by production and Q.A.
 Q.A.department also approves transfer of finished product to finished product store for
sale.
 Q.A. maintains control samples of raw material and finished products.
 Stability studies are carried out by Q.A.
 SOP compliance and GMP implementation is monitored by Q.A.

Management representative Q.A.Incharge Managing Director

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10.0 DISTRIBUTION, COMPLAINTS & PRODUCT RECALL

(a) ARRANGEMENTS AND RECORDING SYSTEM FOR DISTRIBUTION :

Finished goods will be transferred from packing department to finished goods stores with transfer
note, after getting final release for sale from Q.A. department. For each batch of the final product
distribution records are available with dispatch department inside the factory premises

(b) ARRANGMENTS FOR THE HANDLING OF COMPLAINTS AND PRODUCT RECALLS :

On receipt of quality complaints from the customer, Informed to Q.A. department for the same
Q.A. department will recheck retain samples and records for the same. Q.A. will send investigation
report to customer through M.D. In case of critical complaints decision for recalling the product will
be taken by top management and is communicated to distribution manger. Distribution manager
will recall the products as per product recall SOP.

Suggestion / complain register for all complaints / suggestions of external / internal origin will be
maintained & same is reviewed in management review meeting.

Management representative Q.A.Incharge Managing Director

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11.0 SELF INSPECTION

(a) SHORT DESCRIPTION OF SELF-INSPECTION SYSTEM :

The self inspection system is based on the Standard Operating Procedure on cGMP requirements
covering the following items.

a. Personnel
b. Premises including personnel facilities
c. Maintenance of building & equipments
d. Storage of starting materials 7 finished product
e. Equipments
f. Production & In-process controls
g. Quality control
h. Documentation
i. Sanitation & hygiene
j. Validation & revalidation program
k. Calibration of instruments or measurement systems.
l. Recall procedures.
m. Complaint management
n. Labels control
o. Results of previous self-inspection & corrective steps taken

QA head will appoints a self-inspection team from local staff, who are expert in their own field and
with cGMP & if required,outside expert will be retained by us. This self-inspection will be done
once in six month with the help of outside expert.

A report will be made after compliance of the self-inspection, which includes,

1. Self-inspection results
2. Correction & root cause analysis
3. Recommended corrective actions.

The company management evaluates both the self-inspection report and the corrective action as
necessary.

Management representative Q.A.Incharge Managing Director

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 TITLE: Self Inspection
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QUALITY POLICY

 SOLITAIRE PHARMACIA PVT LTD IS COMMITTED TO ACHIEVE

QUALITY STANDARDS USING NATIONAL & INTERNATIONAL
NORMS WITH CONTINUOUS IMPROVEMENT IN PRODUCTS
AND SERVICES FOR ULTIMATE SATISFACTION OF ALL OUR
VALUED CUSTOMERS.

 SOLITAIRE PHARMACIA PVT LTD IS “DEDICATED TO LIFE” AND

QUALITY IS A WAY OF LIFE AT SOLITAIRE PHARMACIA PVT LTD

MANAGING DIRECTOR

( Sanjeev Kumar Sethi )

Management representative Q.A.Incharge Managing Director

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