Pharmaceutical Interview Questions-1

1) What is the definition of SOP? What are contents required for SOP?
Information should master document carry on every page not just one of the
pages to meet GMP? SOPs required for equipment’s? List SOPs required in
QA department?

 SOPs are detailed written instructions for the operation routinely performed in
the course of any activity associated with pharmaceutical manufacturing.
 A written authorized procedure which gives instructions for performing
operations not necessarily specific to a given product / material, but of more
general nature the equipment’s preventive maintenance and cleaning; recall of
product; purchasing; cleaning of premises and environmental control; sampling
and inspection etc.
 These are guidelines which describe how the activity is to be performed. To
achieve uniformity of results by each individual, it is mandatory to follow these
guidelines.
 SOP is like “TELL & SHOW” concept. TELL- means to establish and teach
how the activity is to be carried out. SHOW- means to provide the documented
proof for the activity carried out.
Contents for SOP:
 Objective/ Purpose.
 Scope
 Responsibility
 Accountability
 List of formats/ Annexure
 Procedure
 Abbreviations
 Reference
 Revision History
Information should master document carry on every page not just one of the pages to
meet GMP.
 Page Number
 Document reference number
 Authorizing signature
SOPs required for equipment
 Operation
 Cleaning
 Preventive maintenance/ Calibration

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  Sampling procedure
List of SOPs required in QA department
 SOP for SOP
 SOP for format preparation
 Change control
 Deviation
 Non- conformance products
 Market complaints
 Product recall
 Returned good
 Vendor qualification
 Preparation of BPCR & MPCR
 Assigning pf Mfg. date & Expiry date
 Annual product review
 Corrective action & preventive action
 Process validation, cleaning validation
 Equipment qualification
 Glossary of terms, document control
 Review of BPCR & Analytical test report
 Batch numbering system
 Labeling practice
 Personnel training
 BPCR issue and retrieval
 Batch release
 Self- inspection (internal audit)
 File numbering system
 Preparation of organo- gram
 Preparation of COA
 Specimen signature
 Reprocess & rework of intermediates/ API
 Job responsibilities
 Technology transfer
 Measurable quality objective etc.
2) What is the batch production and control record (BPCR) & master
production & control record (MPCR)
a) Batch production & control record (BPCR)
 BPCR are prepared for each intermediate & API & include the complete
information relating to the completion of each significant step in the batch
production.
b) Master production & control record (MPCR)

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  To ensure the uniformity from batch to batch, master production instruction
for each intermediate & API are prepared, dated & signed by one person,
immediately checked, dated and signed by a person in the quality unit.
c) Content of the MPCR
 The name of the intermediate or API being manufactured & an identifying
document reference code, if applicable.
 A complete list of raw materials & intermediates designated by names or
code sufficiently specific to identify any special quality characteristics
 An accurate statement of quality or ratio of each raw material or
intermediate to be used, including the unit of measure.
 Where the quantity is not fixed, the calculation for each batch size or rate of
production should be included. Variations to quantities should be included
where they are justified.
d) The production location & major production equipment to be used:
 Detailed production instructions, including the:
 Sequences to be followed
 Range of process parameters to be used
 Sampling instruction & in-process controls with their acceptance
criteria, where appropriate
 Time limits for completion of individual processing steps &/or the total
process, where appropriate.
 Expected yield ranges at appropriate phases of processing or time.
 Where appropriate, special notations & precautions to be followed, or
cross references to these.
 The instructions for storage of the intermediated or API to ensure its
suitability for use, including the labeling & packaging materials &
special storage conditions with time limits, where appropriate.
3) What is the difference between intermediated & drug substance (API)? what
is the diff. between drug substance & drug product?
 Intermediate: A material product during steps of the processing of an API
that undergoes further molecular change or purifications before it became
an API (Ref.: ICHQ7A)
 API: Any substance or mixture of substance intended to be used in the
manufacturing of a drug (medicinal) product & that when used in the
production of a drug, becomes an API of the drug product.
 Such substances are intended to furnish pharmacological activity or other
direct effect in the diagnosis, cure, mitigation, treatment or preventive of
disease or to affect the structure & function of the body (Ref.: ICHQ7A)
 Drug substance (API): Any substance or mixture of substance intended to
be used in the manufacture of a drug (medicinal product & that, when used
in the production of a drug becomes an active ingredient of the drug
product. Such substances are intended to furnish pharmacological activity

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 or other direct effect in the diagnosis, cure, mitigation, treatment, or
prevention of disease or to affect the structure and function of the body.
4) What is the diff. GMP & cGMP?
 GMP: is the part of quality assurance which ensure that product is
consistently produced & controlled to the quality standards appropriate to
their intended use & as required by the marketing authorization.
 GMP are aimed primarily at diminishing the risk inherent in any
pharmaceutical production. Such risks are essentially of two types:
 a) Cross- contamination (in particular of unexpected contamination)
 b) Mix-ups (confusion)
 cGMP: Current Good Manufacturing Practices. This mean any procedure/
system adopted by the manufacturer which proves to be necessary &
important for identity, strength & purity of a product.
5) What is the clean room? What is the classification of clean room?
 Clean room are defined as especially constructed, environmentally
controlled enclosed paces with respect to airborne particulates, temperature,
humidity, air pressure, air motion, vibration, noise, viable (living
organisms) & lighting.
 Particulate control includes:
 a) Particulate & microbial contamination
 b) particulate concentration & dispersion
 Generally clean room are classified in to the following types as per different
guidelines:
a) Schedule M: Grade A, Grade B, Grade C, Grade D
b) USFDA (US 209E): Class 1, Class 10, Class 100, Class 1000, Class 10000,
Class 100,000.
c) WHO 2002: Grade A, Grade B, Grade C, Grade D
d) EU GMP: Grade A, Grade B, Grade C, Grade D
e) ISO 146-1: ISO-3, ISO-4, ISO-5, ISO-6, ISO-7, ISO-8, ISO-9
f) Britain (BS 5295): Class C, Class D, Class E or F, Class G or H Class J, Class
K
g) Australia (AS 1386): 0.035, 0.35, 3.5, 35, 350, 3500.
h) Germany (VDI 2083): 1, 2, 3, 4, 5, 6.
6) What is the diff. between qualification & validation?
What is the definition of validation & qualification? What are the types of
validation?
 Process validation is the documented evidence that the process, operated
within established parameters, can perform effectively & reproducible to
produce an intermediate/ API meeting its pre-determined specification &
quality attributes.
 Process validation is three types:
a) Prospective process validation

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 b) Concurrent process validation
c) Retrospective process validation

Prospective process validation:

 Prospective process validation shall be carried out for all the intermediate
stages and active ingredients prior to the distribution of new product. [ICH:
GMP, EU: GMP, PIC/S: GMP]

Concurrent process validation:

 Any validated process undergoes a change either for the equipment or

additional, deletion of a critical manufacturing process step, scale up or scale
down, the same need to be validated concurrently
 The validation is carried out only after a change of an exiting validated process
to support the change made or involve with the requirements. OR
 A substance of prospective validation in which API batches are released for
distribution, based on extensive testing, before completion of process
validation. Once data from additional batches produced under replicated
conditions show uniformity, the process may be considered validated. OR
 Concurrent validation can be conducted when data from replicate production
runs are unavailable because only a limited number of API batches have been
produced, API batches are produced infrequently, or API batches are produced
by a validated process that has been modified. [ICH: GMP, EU: GMP, PIC/S:
GMP]

Retrospective process validation:

 Validation of a process for a product already in distribution based upon

accumulated production, testing & control data. [ICH: GMP, EU: GMP,
PIC/S: GMP]
7) What do you mean by validation protocol & its contents of process
validation?
 A written plan stating, how validation will be conducted and defining
acceptance criteria.
 eg.: The protocol for manufacturing process identifies process equipment,
critical process parameters &/ or operating range, product characteristics,
sampling, test data to be collected, number of validations runs & acceptance
test results.

Contents: Protocol Approval

 Table of contents
 Objective

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  Scope
 Responsibility
 Accountability
 Validation team
 Brief manufacturing process (Description, Flow chart, Reaction scheme)
 Selection of batches
 List of equipment’s used in the manufacturing process
 List of raw material used in manufacturing process
 Critical operations with justification
 In-process controls with acceptance criteria
 Sampling & testing plan with frequency
 Stability program
 Data to be complied
 Acceptance criteria
 Intermediate & final products quality & yield
 Stability specifications
 Document review
 Document review
 Conclusion
 Revalidation criteria
8) What is the definition of the procedure?
 A document description of the operation to be performed, the precautions to
be taken, and measures to be applied directly or in directly related to the
manufacture of an intermediate/ API
9) What is the master document?
 Master document is a formally authorized source document relating to
specifications, and/ or manufacturing/ analytical methods, which is
protected from un-authorized access or amendment.
 Document required describing the quality system requirements in the
organization.
 Document required describing the process the process or product
characteristics.
 Document required by various regulatory agencies as party of compliance
to GMP requirements.
 Document required for legal/ regulatory supports of the organization to
meet the local regulations.
 Any other documents required by government/ regulatory agency.
10) What is documentation?
 All the written procedures, instructions & records, quality control
procedures & recorded test results involved in the manufacturing of a
medicinal product.

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