Professional Documents
Culture Documents
QUESTIONS
Ankur Choudhary
Pharmaguideline | New Delhi, India
Pharmaceutical Interview Questions & Answers
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e.g: The protocol for manufacturing process identifies process equipments, critical process
parameters, and / or operating range, product characteristics, sampling, test data to be collected,
number of validations runs and acceptance test results.
Contents:
Protocol Approval
Table of contents
Objective
Scope
Responsibility
Accountability
Validation team
Brief manufacturing process (Description, Flow chart, Reaction scheme)
Selection of batches
List of equipments used in the manufacturing process
List of raw materials used in the manufacturing process
Critical operations with justification
In-process controls with acceptance criteria
Sampling & testing plan with frequency
Stability programm
Data to be complied
Acceptance criteria
Intermediate & final products quality & yield
Stability specification
Document review
Conclusion
Revalidation criteria
21. What is the definition of the procedure?
A documented description of the operation to be performed, the precautions to be taken, and
measures to be applied directly or indirectly related to the manufacture of an intermediate / API
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Investigating problems
Continual improvement of performance
Assessing for Registration
Reducing cost of operation
Legal requirement
Types: 1. Study/test-based inspection
2. Facility based inspection
3. Process based inspection
40. Why nitrogen gas used in the manufacturing area at room temperature and why not
other gas? Because of nitrogen is chemically less reactive and does not react with other
elements at ordinary temperature. It is due to strong bonding in its molecule.
41. What are the different types of cleanings?
There are three types of cleanings:
Batch to Batch cleaning
Periodically cleaning
Product change over cleaning
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standards or specifications, back into the process and repeating a crystallization step or other
appropriate chemical or physical manipulation steps (e.g., distillation, filtration,
chromatography, and milling) that are part of the established manufacturing process.
Continuation of a process step after an in-process control test has shown that the step is
incomplete, is considered to be part of the normal process, and is not reprocessing.
Reworking: Subjecting an intermediate or API that does not conform to standards or
specifications to one or more processing steps that are different from the established
manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with
a different solvent).
45. What is deviation & its types?
Deviation is departure from the approved instructions /established standards.
There are two types of deviation and given below:
Controlled / planned deviation: Any deviation from documented procedure opted deliberately
for temporary period to manage unavoidable situation or improving the performance of the
operations, without affecting the quality & yield of drug substance and safety of the operations
shall be termed as controlled / planned deviation.
Uncontrolled / unplanned deviation: Any deviation occurred in unplanned or uncontrolled manner
such as system failure or equipment breakdown or manual error shall be termed as uncontrolled
/ unplanned deviation.
46. What is change control and its types?
Change control is a system that control change by
iii. Preventing changes that could adversely affect product quality or conflict with
registration or regulatory requirement.
iv. Providing an assessment of change and monitors the impact of change.
Level 1 (Minor): Are those that are unlikely to have any detectable impact on the quality
attributes of the product.
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Level 2 (Major): Are those that are likely to have a significant impact on the
quality attributes of the product.
The type of reasons for change control:
- Regulatory requirement
- GMP implementation / enhancement
- Quality improvement
- Capacity enhancement
- Introduction of new product in existing facility
- Cost reduction
- Automation
- Aging of facility
- To manage the unavoidable situation
- Market requirement
47. What is contamination and cross-contamination?
Contamination: The undesired introduction of impurities of a chemical or Microbiological nature,
or of foreign matter, in to or onto a raw material, intermediate, or API during production, sampling,
packaging or repackaging, storage or transport.
Cross-contamination: Contamination of a material or of a product with another material or
product.
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A process parameter whose variability has an impact on a critical quality attribute and
therefore, should be monitored or controlled to ensure the process produces the desired quality.
51. What is mother liquor?
The residual liquid which remains after the crystallization or isolation processes. Mother liquor
may contain un-reacted materials, intermediates, levels of the API and/or impurities. It may be
used for further processing.
52. What is the difference between theoretical and expected yield?
Theoretical yield: The quantity that would be produced at any appropriate phase of production,
based upon the quantity of material to be used, in the absence of any loss or error in actual
production.
Expected yield: The quantity of material or the percentage of theoretical yield anticipated at any
appropriate phase of production based on previous laboratory, pilot scale, or manufacturing
data.
53. What is OOS?
Out of Specification (OOS) results are those results, generated during testing that do not
comply with the relevant specification or standards or with the defined acceptance criteria.
54. What is CAPA?
CAPA is the Corrective Action & Preventive Action.
Corrective Action: Action taken to eliminate the causes of an existing non-conformity, defect or
other undesirable situation to prevent recurrence. [Actions taken after the occurrence of a defect
or problem to stop the same from recurrence].
Preventive Action: Action taken to eliminate the causes of potential non-conformity, defect or
other undesirable situation to prevent occurrence. [Actions initiated before the occurrence of a
defect or problem to prevent the same occurrence].
55. What is the ICH? Write its aim/purpose and names of the different parties & different
regions?
ICH means “International conference on harmonization”.
Aim/Purpose: “Ensure good quality, safety and effective medicines are developed and
registered in the most effective manner, through harmonization of technical requirements”
Different Parties:
1. European commission – European Union (EMEA)
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its
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To achieve this objective, electrical, mechanical & electronic components are arranged in
several configurations such that they produce the expected results.
63. What is the meaning of Q, S, E, M in the ICH?
“Q” stands for Quality; “S” stands for Safety, “E” stands for Efficacy and “M” stands for Multi
dispensary
64. How many guidelines are present in Q & what are those, describe in detail?
In Quality (Q), total 10 guidelines are present. Those are as follows:
1. Q1 - Stability
2. Q2 - Analytical Method validation
3. Q3 - Impurities
4. Q4 - Pharmacopoeia
5. Q5 - Biotechnological quality
6. Q6 - Specification
7. Q7 - Good Manufacturing Practice (GMP)
8. Q8 - Pharmaceutical Development
9. Q9 - Quality Risk Management
10. Q10 - Pharmaceutical Quality System
65. How many types of raw material and packing material?
Raw materials are classified into two types. Those are as follows:
1. Key raw material
2. Other raw material
Packing materials are classified into two types. Those are as follows:
1. Primary Packing material
2. Secondary Packing material
66. Define the Key raw material/ starting material & primary packing material?
Key raw material/starting material:
Starting material shall be defined as that which is
Incorporated as a significant structural fragment of the API / Drug Intermediate and
Having significant effect on the Quality and Yield of the product.
Starting material shall be identified in TDP.
Primary Packing material: Packing material, which come in direct contact with the
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Pathogens :
E. coli Absent
Salmonella Absent
Pseudomonas Absent
Staphalococcus aureus Absent
79. Write the different storage conditions as per any guidelines (specify the name of
guideline)?
The different storage conditions are given below as per USP:
Freezer : -25°C to -10°C
Cold : Any temperature not exceeding 8°C
Refrigerator : Between 2°C and 8°C
Cool : 8°C to 15°C
Room temp. : The temperature at prevailing working area.
CRT : 20°C to 25°C
Warm : 30°C to 40°C
Excessive heat :Above 40°C
80. What is Fumigation?
Fumigation is the act of killing insects, bacteria, and fungi through the use of fumigants.
Fumigants are chemicals that can be used to kill small insects, bacteria, and fungi. They are
used in many industries like pharmaceuticals, cleaning products, heavy machinery, and food
canning. Fumigation is a form of treatment which address issues related to pests or pathogens
that might be present in a building or object.
81. Write the names of some fumigation agents?
The most commonly used fumigation agents are: Hydrogen Peroxide, Aldrin,
Hexachlorobenzene and Benzene. These agents are very toxic to humans as they can cause
irritation of the mucus membranes in the nose, eyes and throat. Sometimes they also cause
headaches and nausea or dizziness.
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82. Write the different types of fires, which are generally used in the pharmaceutical industry?
a) Chemical fire
b) Electrical fire
c) Metal fire
d) General fire
e) Gaseous fire
83. What is ISO 9001, ISO 14001, ISO 18001, ISO 22001?
ISO 9001 : Quality Standard Management
ISO 14001 : Environmental Standard Management
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92. Do you have any idea about schematic diagram of HVAC system?
Fresh Air
Filtering of Air with Pre filter
Cooling & Heating coil
Filtering of Air with Fine filter
Filtering of air with HEPA filter, If required
Suction of air through return ducts from the process area using some pre filters as per
requirements
Air is exhausted to atmosphere after filtration wherever required
Portion of air then passes through a dehumidifier wherever dehumidifier is required
In the mixing chamber, return Air & Fresh air get mixed
Process repeats from
93. If two different products are manufacturing in two modules of one production block, then
will you accept the common air handling unit for both pharma area? Write “Yes” or “No”
with reason?
No, because of cross-contamination (if re-circulation of return air)
Yes, if 100% of fresh air is circulated through the respective area.
94. Why blending validation is required? What quality parameters of product are
considered for validation and what parameters of equipment are to be considered
during validation? Because of to provide sufficient documented evidence to assure that the
blending operation of product is capable of repeatedly and reliably producing a
homogeneous material to meet established specifications when operated under defined
standard conditions.
The following Quality parameters are to be considered, but not limited:
a) Loss on Drying / Water content
b) Bulk density / tapped density
c) Residual solvent
d) Particle size
The following parameters are to be considered for the equipment during validation, but not
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limited:
a) Blender capacity
b) RPM of the blender
c) Occupancy of the blender
d) Number of individual batches to be taken for each blend
e) Mixing time
95. What is the formula for calculation of “Air changes per hour” during HVAC validation?
Total CFM of the blower/Filter x 60
Air changes per hour= ---------------------------------------------------
96. During the performance qualification in the vacuum tray dryer, how many temperature
probs used?
Total 16 to 24 temperature probes are to be kept during the performance qualification of the
vacuum tray dryer (or number of probes specified in the protocol)
97. What is the formula for the calculation of “MACO” while cleaning between one API to
another API?
Minimum therapeutic dosage of previous product X Minimum batch size of next
product
MACO
= Safety factor X Maximum therapeutic dosage of the next product
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98. What is the limit for “Individual unknown Impurity” in API as per ICH Q2A?
The limit of the “Any individual unknown Impurity” is not more than 0.1%
99. What are the class-I solvents as per ICH Q3C?
Benzene - 2 ppm Carbon tetrachloride - 4 ppm 1,2-
Dichloroethane - 5 ppm 1,1-Dichloroethene - 8 ppm 1,1,1-
Trichloroethane - 1500 ppm
100. What is the abbreviation of CAS Number?
CAS Number : Chemical Abstract Service Number
101. What is the specific gravity of Methylene chloride?
Specific gravity of Methylene chloride is 1.308 g/ml
102. If equipment is cleaned with water, then finally it should be rinse with suitable solvent
as per guidelines, why?
Because of the last step of the cleaning procedures involve drying with solvent or flushing with
nitrogen, thus ensuring that there is no opportunity for microbial growth.
103. What is mean by “4M”?
“4M” means Man, Machine, Method and Material
104. If supposed your pharma area is class 100000, then what is the maximum light
and sound level as per guidelines?
The light & sound level limits are given below for class 100,000 / ISO 8:
Light Level : Not less than 300 Lux
Sound Level : Not more than 80 decibels
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permanent location. Generally, in a configuration very similar to that in which it is utilized for
production. This procedure widely known as Clean-in-Place (CIP)
Clean-out-Place: The smaller items are frequently transported to a designated cleaning or
washing area where the cleaning procedures is performed. This practice is known as clean-out
-place (COP)
107. What is the name of the instrument, which is used for measuring of vacuum (in
Tars) during high vacuum distillation?
Macleod gauge
- Warehouse Personnel
-
- Safety & Environment
- Engineering
- Estate Management
- Info tech
111. Why do we conduct trainings?
It brings awareness and helps us in becoming competent.
112. What is personal hygiene?
Each personal should:
- Wear clean uniform
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to be authentic material that should be of high purity. This standard may be obtained from an
officially recognized source or may be prepared by independent synthesis or by further
purification of existing production material.
Working Standard: A substance of established quality and purity, as shown by comparison to a
primary reference standard, used as a reference standard for routine laboratory analysis
125. What is abbreviation of CTD?
“CTD” means Common Technical Document. This is addressed in the ICH guidelines in the
section of “M” and in the part of “M4”
126. What do you mean by market complaint?
Any communication, written or verbal, received regarding the quality, packing directly from any
traders or product manufacturer and marketing staff or any other such complaints shall be
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Minor: Those findings that require corrective action plan as agreed between the Auditee
department Head and Quality Assurance.
130. How many phases are divided the performance qualification of purified water
system and write the duration of each phase?
Performance qualification of purified water system is divided into the three phases and
described below:
Phase-I: (a) Develop & finalize operating, preventive maintenance, sanitization procedures.
(b) Demonstrate production & delivery of water of required quality.
(c) To finalize SOP on sanitization, Alert & Action limits.
(d) Phase – I shall be conducted for 30 days.
Phase-II: (a) Demonstrate consistent operation within established ranges.
(b) Demonstrate consistent production & delivery of water of required quality.
(c) Phase – II shall be conducted for 30 days.
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132. What are the QA activities during the vendor qualification for Key starting raw material,
give flow chart?
New Vendor
Quality
Evaluate minimum 3 Complies/
Starting consignments as per Approved
specifications
Vendor Quality
evaluated at Request purchase of
samples of three complies?
R&D?
distinct lots
Receive Vendor
Questionnaire/ TDP
Lab/Plant
trial/stability Ok?
Reject Vendor
Information
Approve Vendor Update approved
adequate?
vendor List
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134. What are the QA activities during the vendor qualification for Primary packing
material, give flow chart?
New
Vendor Data shall be
available for 3
consignments
Vendor
Polymeri samples
quality OK?
Approved
Reject vendor
Vendor
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sampled or directly extracted by solvent. The areas which are not reasonably accessible for
direct surface sampling have to be rinsed with suitable solvent.
When more than one equipment is involved (equipment chain) for rinsing, suitable
quantity of solvent shall be used and the rinse volume shall be measured.
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As per EU GMP:
Maximum permitted number of particles/m3 equal or above
Grade At Rest In Operation
> 0.5 μm >5.0 μm > 0.5 μm >5.0 μm
A 3500 0 3500 0
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of the DMF.
152. What are the types of DMF?
There are four types of DMF. They are referred to by their numbers in Roman numerals:
Type-II: DMF is for companies who supply drug substances, drug products, intermediates &
material used in their manufacture.
Type-III: DMF is for companies who supply packaging (container closure system) for human
drugs & biologics.
Type-IV: DMF is for companies who supply excipients
Type-V: DMF is for companies who supply clinical services, sterile manufacturing etc.
Type-I: Is an obsolete number once used for a category that no longer exists because it was
found to easily fit into and overlap with the other four categories.
153. What are the possible reasons for the non-conformities?
The following are the possible reasons, but not limited:
- Management attitude
- Ineffective documentation
- Lack of trained personnel
- Lack of co-ordination / co-operation within or among departments.
154. What do you mean by Critical Quality Attributes?
A critical quality attributes is a physical, chemical, biological or microbiological property or
characteristic that should be within an appropriate limit, range, or distribution to ensure the
desired product quality.
155. What are the test parameters in the nitrogen gas validation?
Test parameters during validation and its frequency are given below:
a) Test for oil mists - Every 6 months once
b) Test for moisture content - Every 6 months once
c) Particulate count (Non-viable) - Every 6 months once
d) Sterility test (Aseptic area locations) - Every 6 months once
e) Bio burden test (Controlled area locations) - Every 6 months once
* Perform the nitrogen gas sampling & testing for three consecutive days.
f) Purity of nitrogen gas (Based on manufacturer COA)
156. What do you mean by Non-conformity?
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162. What are the different types of safety factors used in the pharmaceutical industries?
1/10 to 1/100th of normal daily dose = Topical products
1/100 to 1/1000th of normal daily dose = Oral products
1/1000 to 1/10000th of normal daily dose = Inject able & Ophthalmic products
1/10000 to 1/100000th of normal daily dose = Research, investigational
products.
163. What do you mean by reconciliation?
A comparison, making due allowance for normal variation, between the amount of product or
material theoretically & actually produced/used.
164. What are the contents of Annual product quality review (APQR)?
1) Introduction
4) Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products
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5) Summary of changes made during the year with respect to equipment, Process,
Specifications, and Methods, Raw materials and others.
7) List of customer complaints; Return goods and Recalled goods along with description and
actions taken
8) Number of Reprocessed and Reworks batches in all stages during the year-2009
9) Review of Key starting materials and Primary packing materials and Rejections.
15) Status of Drug Master File (if any), Drug Master File new updates
165. Which solvents are categorized in the organic volatile impurities (OVI)?
Methylene chloride - 600 ppm
Chloroform - 60 ppm
1,1,2-Tri chloro ethylene - 80 ppm
1,4-Dioxane - 380 ppm
166. What do you mean by customer satisfaction?
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Customer’s perception of the degree to which the customer’s requirements have been fulfilled
Any customer wants three things:
- Good product
- Timely feedback
- Timely supply
167. What is the QMS?
It is the quality management system to direct and control an organization with regard to quality.
168. What do you mean by pre-determined acceptance criteria?
The criteria assigned, before undertaking testing to allow evaluation of test results to
demonstrate compliance with a test phase of delivery requirement.
169. What is Master validation Plan (VMP)?
A document providing information on the company’s validation work program. It should define
details of and timescales for the validation work to be performed. Responsibilities relating to
the plan should be stated.
170. What do you mean by product recall?
Products recall means removal or withdraw of marketed material due to violation in laws &
regulations as per regulatory authorities or not conforming to the customers’ specifications.
171. What do you mean by residual solvent?
These are the traces of the solvents left during the manufacturing of drug substances or drug
products. Residual solvents are not completely removed by practical manufacturing techniques.
172. How can we avoid contaminations in warehouse?
Contamination can be avoided by:
- Proper segregation / identification of different RMs
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- Hand gloves
- Training on safety rules and use of safety equipment.
176. Would you like to recommend any precautions while operating the equipment?
Following precautions are recommended:
- Make sure that each equipment is numbered and its log is maintained.
- Check whether the equipment is cleaned as per SOP
- Always follow product changeover procedure during product changeover
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paragraph
Annexure: Environmental Risk Assessment
Module-2 (QOS):
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Module-3 (Quality):
Table of Contents
Body of Data
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3.2.S.1.1 Nomenclature
3.2.S.1.2 Structure
3.2.S.1.3 General Properties
3.2. S.2 Manufacture
3.2.S.2.1 Manufacturers
3.2.S.2.2 Description of Manufacturing Process and Process Controls
3.2.S.2.3 Control of Materials
3.2.S.2.4 Controls of Critical Steps and Intermediates
3.2.S.2.5 Process Validation and/or Evaluation
3.2.S.2.6 Manufacturing Process Development
3.2. S.3 Characterization
3.2.S.3.1 Elucidation of Structure and other Characteristics
3.2.S.3.2 Impurities
3.2. S.4 Control of Drug substance
3.2.S.4.1 Specification
3.2.S.4.2 Analytical Procedures
3.2.S.4.3 Validation of Analytical Procedures
3.2.S.4.4 Batch Analyses
3.2.S.4.5 Justification of Specification
3.2. S.5 Reference standards or materials
3.2. S.6 Container Closure system
3.2. S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions
3.2.S.7.2 Post approval Stability Protocol and Stability Commitment
3.2.S.7.3 Stability Data
179. What annexure are to be submitted while submitting the Drug Master File?
The following annexure are to be submitted during the initial submission wherever applicable:
Annexure- 1 : Letter of Authorization
Annexure-2 : Letter of Agreement (Where the manufacturer is not intended holder of a
certificate of suitability)
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180. Write the different parts of 21 CFR and details of different subparts of 21 CFR 211?
21 CFR Part 11 : Electronic records, electronic signatures, electronic copies of electronic
record
21 CFR Part 58 : GLP for Non-clinical Laboratory studies regulation
21 CFR Part 210 : cGMP in manufacturing, processing, packing / holding of drug
21 CFR Part 211 : cGMP regulations for finished pharmaceuticals
21 CFR Part 820 : GMP regulations for medical
devices Subpart A (General Provisions):
21 CFR Section 211.1 : Scope
21 CFR Section 211.3 : Definitions
Subpart B (Organization and Personnel):
21 CFR Section 211.22 : Responsibilities of Quality unit
21 CFR Section 211.25 : Personnel Qualification
21 CFR Section 211.28 : Personnel
Responsibilities 21 CFR Section 211.34 :
Consultants
Subpart C (Building and Facilities):
21 CFR Section 211.42 : Design & construction features
21 CFR Section 211.44 : Lighting
21 CFR Section 211.46 : Ventilation, Air filtration, Air heating & cooling
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181. What parameters are to be considered during the analytical method validation of
related substance or Residual solvents?
The following parameters are considered during the analytical method validation of related
substances or Residual solvents:
S. No. PARAMETERS
1.0 Demonstration of precision
1.1 System precision / System suitability
1.2 Sample precision
2.0 Solution stability
6.0 Linearity
7.0 Ruggedness
182. What parameters are to be considered during the analytical method validation of Assay?
S. No. PARAMETERS
1.0
System suitability
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2. 0 System precision
3. 0 Sample precision
5. 0 Assay Content
6. 0 Accuracy
7. 0 Linearity
8. 0 Ruggedness
183. What are the different conditions conducted during the forced degradation study?
The following conditions are conducted during forced degradation study:
a) Thermal degradation
b) Photo degradation (Direct sunlight)
c) Acid hydrolysis
d) Base hydrolysis
e) Oxidation
f) Ultra-violet exposure
184. What is clean zone and clean room?
Clean zone: A defined space in which the concentration of air borne particles is controlled to
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190. What are the contents of South Africa (MCC) GMP Guidelines?
Chapter 1: Quality Management
Principles
Quality Assurance
Good Manufacturing Practice
Quality Control
Audits
Quality Evaluation Audits
Critical Procedures
quipment
Chapter 5: Manufacturing
Principle
Validation
Dispensing
Manufacturing Operations
In-process Control
Contamination
Reprocessing
Chapter 6: Packaging
Principles
Component Issue
Packaging Operations
In-process Control
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Contamination
Finished Product Release
Chapter 7: Quality Control
Principles
Responsibilities
Equipment
Personnel
Sampling
Testing
Standards, reagents
Documentation
Stability
Chapter 8: Documentation
Principles
Preparation, Issue and Use of Documents
Master Specifications
Master Manufacturing Instructions
Master Packaging Instructions
Batch Records (Starting Materials)
Batch Records (Packaging Materials)
Batch Records (Manufacturing)
Batch Records (Packaging)
Other Procedures and Records
Analytical Records
Other Documentation Required
Chapter 9: Validation
Principles
Validation Master Plan
Validation Protocol
Validation Report
Qualification
Process Validation
Analytical Method Validation
Cleaning Validation
Computer System Validation
Validation of specific dosage forms
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Complaints
Adverse Events
Recalls
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Documentation
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191. What are the contents of Korean Drug Master File (KDMF)?
Section Contents
1.0 Facilities of Manufacturing site
1.1 Drawings of the whole site plan (each production, laboratory, storage area and
other accessory facilities for production should be labeled for area names, gates,
and corridor)
1.2 A simple plan showing the classification of the rooms (e.g. Class I, II, III, IV) using
different colors according to cleanliness
1.3 Schematic Drawings of air-ventilation system
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2.1.1 Origin, finding and developmental history (including when, where, from
what and who extracted, isolated or synthesized the drug, what became the
fundamental source of such finding and when and where the non-clinical
studies and the clinical trial started)
2.1.2 Data on structure elucidation, physico-chemical properties and biological
properties
2.1.3 In case any patent has been acquired in Korea or foreign countries, data
including a copy of the patent register, etc.
2.2 Data on stability
2.2.1 As data in conformity with the "Guidance on Stability Test of Drugs, etc." as
stipulated by the FDA Commissioner, specific analytical methods shall be
described and raw data shall be attached.
2.2.2 Test Methods
Section Contents
3. Data on the manufacturing processes, packaging, containers, cautions in handling, etc.
3.1 Manufacturing processes
3.1.1 The overall manufacturing process flow shall be described in detail, and such
description shall include matters relating to in-process controls by each
manufacturing step. And data on starting materials, solvents, reagents, etc.
used in each manufacturing process, such as synthesis (fermentation),
isolation, purification, etc. shall be attached.
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The Site Master File provides information on the manufacturer’s operations and procedures that
can be useful in the efficient planning and undertaking of a GMP inspection.
S. No. Contents
C.1 General Information
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C.1.1 Brief information on the firm (including name and address), relation to other sites and,
particularly, any information relevant to understand the manufacturing operations
C.1.2
Pharmaceutical manufacturing activities as licensed by the Competent Authorities
C.1.3
Any other manufacturing activities carried out on the site
C.1.4Name and exact address of the site, including telephone, fax and 24 hrs
telephone
numbers
Type of actual products manufactured on the site and information about specifically
C.1.5
toxic or hazardous substances handled, mentioning the way they are
manufactured (in
dedicated facilities or on a campaign basis).
C.1.6 Short description of the site (size. location and immediate environment and
other
manufacturing activities on the site).
C.1.7 Number of employees engaged in the quality assurance, production, quality
control,
storage and distribution
C.1.8 Use of outside analytical or other technical assistance in relation to
scientific,
manufacture and analysis
C.1.9 Short description of the quality management system of the firm responsible for
manufacture
C.2 Personnel
C.2.1 Organization chart showing the arrangements for quality assurance, including
production
and quality control
C.2.2
Qualification, Experience and Responsibilities of key personnel
C.2.3
Outline of arrangements for basic and in-service training and how records are maintained
S. No. Contents
C.2.
Health Requirements for personnel in the production
4
C.2.
Personnel Hygiene requirements, including clothing
5
C. Premises and Equipment
3
C.3. Simple plan or descriptions of manufacturing areas with indication of scale architectural
1 or engineering drawings are not required).
C.3.
Nature of Construction and finishes
2
C.3.
Heat Ventilation & Air Conditioning System (HVAC)
3
C.3.
Handling of Toxic, Hazardous and Sensitizing Chemicals
4
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C.3. Brief description of water systems (schematic drawings of the systems are desirable)
5 including sanitation
C.3. Maintenance (description of planned preventive maintenance programmes and recording
6 system
C.3.
Brief description of major production and control laboratories equipment
7
C.3. Maintenance (description of planned preventative maintenance programmes and
8 recording system).
C.3. Qualification and calibration, including recording system. Arrangements for computerized
9 systems validation
C.3.1 Availability of written specifications and procedures for cleaning manufacturing areas
0 and equipment
C.
Documentation
4
C.4. Arrangements for the preparation, revision and distribution of necessary documentation
1 for manufacture
C.4. Any other documentation related to product quality which is not mentioned elsewhere
2 (e.g. microbiological controls on air and water)
C.
Production / Manufacturing
5
Brief description of production operations using, wherever possible, flow sheets and
C.5.
charts specifying important parameters (see at Appendix the list of products
1
manufactured)
C.5. Arrangements for the handling of starting materials. Packaging materials, bulk and
2 finished products, including sampling, quarantine, release and storage
C.5.
Arrangements for Reprocessing and Rework
3
C.5.
Arrangements for the Handling of Rejected Materials & Products
4
C.5.
Brief Description of General Policy for Process Validation
5
C.
Quality Control
6
S. No. Contents
C Description of the Quality Control system and of the activities of the Quality Control
. Department Procedures for the release of finished products
6
.
1
C.
Contract Manufacturers and Analytical Laboratories
7
C.
Distribution, Compliance and Product Recall
8
C.8.
Arrangements and Recording System for Distribution
1
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C.8.
Arrangements for handling of Complaints and Recalls
2
C.
Short description of the Self Inspection system
9
EDI, just as in conventional ion exchange, cations and anions in the feed water are exchanged for
hydrogen and hydroxyl ions in the ion exchange resins, producing de-mineralized water. The key
operational difference is that with EDI, the ion exchange resin is regenerated continuously, while with
conventional ion exchange, chemical regeneration is performed intermittently.
Continuous regeneration in EDI is achieved electrochemically by means of ion conducting membranes
and an imposed electric current. The hydrogen and hydroxyl ions necessary for regeneration are
formed in-situ, without the addition of chemical reagents, by means of the familiar water dissociation
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Pre-Treatment Plant
EDI System
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UV TREATMENT
USER POINT
The validation of purified water generation shall be done in three phases. The purpose and sampling plan is
described as below:
The initial phase (phase-I) typically begins only after successfully completion of operational qualification. The
water generated during the second phases will be used for the manufacturing as long as the water meets
the specifications.
PHASE- I
During this phase daily samples were taken and analysed for chemical and microbiological quality. Sampling
should be after each step in the treatment process and from each point of use. The incoming feed water will
also be tested to verify the compliance with the specifications. The phase-I shall be performed for a minimum
period of 30days.
At the end of this phase alert and action limits will be established. These alert and action limits will
be used during phase-II and beyond.
The data obtained during phase-I should be used to develop the SOP and confirm that, the operational SOPs
are adequate.
Alert and Action limits shall be calculated based on the phase-1 study.
PHASE- II
This phase is to demonstrate that the system consistently operates within predetermined operating ranges
and delivers the water of the required quality (as specified) when operated in accordance with the SOPs.
The sampling plan will be the same as phase -I, and this activity will continue for 30 days after completion of
phase-I.
PHASE- III
This phase will be continued for 10months to verify the extended performance of system procedures on the
quantity and quality of water despite possible seasonal variations of feed water.
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At the end of this phase the performance qualification is considered as completed and on going monitoring
will be established a continuous record of water quality. This activity is under progress. During this phase
purified water samples are collected daily from minimum one point of use, covering all points in a week .
PHAS PRIMARY
E OBJECTIVES
Develop & Finalize operating, preventive maintenance, sanitization
procedures.
I
Demonstrate production and delivery of water of the required quality
To finalize the SOP on sanitization, Alert & Action Limit.
Demonstrate consistent operation within established ranges.
II Demonstrate consistent production and delivery of water of the required
quality.
Demonstrate extended performance.
III
Ensure that potential seasonal variations are evaluated and treated.
Phase-I: samples shall be collected daily from all user points and tested for chemical and Microbiological
parameters. Chemical parameters like pH, TOC, Conductivity, Nitrates and Heavy metals were tested. For
Microbiology use high nutrient and low nutrient media to isolate the stressed organism.
The rationale of being low nutrient agar (R2A) being used during the validation of purified water was to
enumerate and isolate any adverse microorganisms, which are either slow growing or injured during
preliminary stages of water treatment. The bio-flim formed by the endogenous microorganism adsorbed on
to the surface is also indicative of surviving in low nutrient medium.
The samples tested using high nutrient agar were incubated at 30-35°C for 5 days and those tested using
low nutrient agar were incubated at 20-25°C for 7 days
Analyse the sample as per the Standard Operating Procedure. Phase-I will be started and duration of study
is minimum 30 days.
Phase-II: samples shall be collected daily from all user points and tested for Chemical and Microbiological
parameters. Chemical parameters like pH, TOC, Conductivity, Nitrates and Heavy metals were tested. For
Microbiology use high nutrient and low nutrient media to isolate the stressed organism.
The rationale of being low nutrient agar (R2A) being used during the validation of purified water was to
enumerate and isolate any adverse microorganisms, which are either slow growing or are injured during
preliminary stages of water treatment. The bioflim formed by the endogenous microorganism adsorbed on to
the surface are also indicative of surviving in low nutrient medium.
The samples tested using high nutrient agar were incubated at 30-35°C for 5 days and those tested using
low nutrient agar were incubated at 20-25°C for 7 days
For Microbiology use high nutrient and low nutrient media to isolate the stressed organism. Analyse the
sample as per the Standard Operating Procedure. Duration of Phase-II study is minimum 30 days.
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Phase-III: samples are collected daily from minimum one point of use, covering all points in a week for
Chemical and Microbiological parameters. For Microbiology use high nutrient media to isolate the stressed
organism. Analyse the sample as per the Standard Operating Procedure.
The samples tested using high nutrient agar was incubated at 30-35°C for 5 days. Duration of Phase-III
study is 10 months which also includes the seasonal variations .
194. What microbial & chemical parameters are to be considered during the
nitrogen gas validation?
01. Sterility Test should be sterile
02. Particulate Matter
Black White Fibers
Visual Particles NIL NIL NIL
LBPC (In House) 10 - NMT 25/100 mL
25 - NMT 10/100 mL
03. Non-viable particle count
Maximum concentration limits for particles should be 0.5 = 1000/Ft3 & 5 = 70/
Ft 3 (ISO 8)
04. Bio burden Not more than 10cfu /100mL
05. Purity Not less than 99.5% (Based on manufacturer COA)
06. Oil mist Not more than 1.0 mg/m3
07. Moisture content Not more than 80 mg/m 3
[* LBPC means “Liquid Born Particle Count]
195. What microbial & chemical parameters are to be considered during the
compressed air validation?
01. Sterility Test should be sterile
02. Particulate Matter
Black White Fibers
Visual Particles NIL NIL NIL
LBPC (In House) 10 - NMT 25/100 mL
25 - NMT 10/100 mL
03. Non-viable particle count Maximum concentration limits for particles should be 0.5 =
1000/Ft3 & 5 = 70/ Ft 3 (ISO 8)
04. Bio burden Not more than 10cfu /100mL
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