Pharmaceutical Interview Questions

Pharmaceutical Interview Questions - 1

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Pharmaceutical interview Questions

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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? List SOPs required in QA department

2. What is the Batch production and control record (BPCR) & Master Production & control record (MPCR)?

3. What is the difference between intermediate and drug substance (API)? What is the difference between drug substance and drug product?

4. What is the difference between GMP & cGMP?

5. What is the clean room? What are the classifications of clean rooms?

6. What is the difference between Qualification and Validation? What is the definition of Validation & Qualification? What are the types of validation?

7. What do you mean by validation protocol and its contents of process validation?

8. What is the definition of the procedure?

9. What is the master document?

10. What is documentation?

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?
List SOPs required in QA department

· SOPs are detailed written instructions for the operations routinely performed in the course of any activities associated with pharmaceutical manufacturing.

· A written authorized procedure which gives instructions for performing operations not necessarily specific to a given product / material, but of a more general nature the equipment preventive maintenance and cleaning; recall of products; 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 a “TELL and 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 of 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 signatures

SOPs required for equipment

Operation
Cleaning
Preventive maintenance/ Calibration
Sampling procedure

List SOPs required in QA department

· SOP for SOP

· SOP for format preparation,

· Change control

· Deviation

· Non-conformance products,

· Market complaints

· Product recall

· Returned goods

· Vendor qualification

· Preparation of BPCR & MPCR

· Assigning of 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 signatures

· Reprocess & rework of intermediates / API

· Job responsibilities

· Technology transfer

· Measurable quality objectives etc.

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2. What is the Batch production and control record (BPCR) & Master Production & control record (MPCR)?

Batch production and control record (BPCR)

BPCR are prepared for each intermediate and API and include the complete information relating to the completion of each significant step in the Batch production.

Master production & control record (MPCR)

To ensure the uniformity from batch to batch, master production instructions for each intermediate and API are prepared, dated and signed by one person, immediately checked, dated and signed by a person in the quality unit.

Content of the MPCR

The name of the intermediate or API being manufactured and an identifying document reference code, if applicable

A complete list of raw materials and intermediates designated by names or codes sufficiently specific to identify any special quality characteristics

An accurate statement of the quantity 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

The production location and major production equipment to be used

Detailed production instructions, including the:

o Sequences to be followed

o Ranges of process parameters to be used

o sampling instructions and in-process controls with their acceptance criteria, where appropriate

o Time limits for completion of individual processing steps and/or the total process, where appropriate

o Expected yield ranges at appropriate phases of processing or time

o Where appropriate, special notations and precautions to be followed, or cross references to these

· The instructions for storage of the intermediate or API to ensure its suitability for use, including the labeling and packaging materials and special storage conditions with time limits, where appropriate.

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3. What is the difference between intermediate and drug substance (API)? What is the difference between drug substance and drug product?

· Intermediate: A material produced during steps of the processing of an API that undergoes further molecular change or purifications before it become an API (Reference: ICH Q7A).

· API: Any substance or mixture of substances intended to be used in the manufacturing of a drug (medicinal) product and 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 prevention of disease or to affect the structure & function of the body (Reference: ICH Q7A).

· Drug substance (API): Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and 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 or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body (Reference: ICH Q7A).

· Drug product: The dosage form in the final immediate packaging intended for marketing (Reference: ICH Q7A).

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4. What is the difference between GMP & cGMP?

· GMP: GMP is the part of Quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

· GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.

Such risks are essentially of two types:

1. Cross-contamination (in particular of unexpected contamination)

2. Mix-ups (confusion)

· cGMP: Current Good Manufacturing Practices. This means any procedure / system adopted by the manufacturer which proves to be necessary and important for identity, strength and purity of a product.

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5. What is the clean room? What are the classifications of clean rooms?

· Clean rooms are defined as especially constructed, environmentally controlled enclosed spaces with respect to airborne particulates, temperature, humidity, air pressure, air low patterns, air motion, vibration, noise, viable (living organisms) and lighting.

· Particulate control includes:

o Particulate & microbial contamination

o Particulate concentration & dispersion

Ø Generally clean rooms are classified in to the following types as per different guidelines:

· Schedule M: Grade A, Grade B, Grade C, Grade D
· USFDA (US 209E): Class 1, Class 10, Class 100, Class 1000, Class 10000, Class 100,000
· WHO 2002: Grade A, Grade B, Grade C, Grade D
· EU GMP: Grade A, Grade B, Grade C, Grade D
· ISO 14644-1: ISO-3, ISO-4, ISO-5, ISO-6, ISO-7, ISO-8, ISO-9
· Britain (BS 5295): Class C, Class D, Class E or F, Class G or H, Class J, Class K
· Australia (AS 1386): 0.035, 0.35, 3.5, 35, 350, 3500
· Germany (VDI 2083): 1, 2, 3, 4, 5, 6

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6. What is the difference between Qualification and Validation? What is the definition of Validation & Qualification? What are the types of validation?

· Qualification is equipment / instrument oriented but validation is process oriented.

· Validation is the documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria.

· Qualification is the action of proving and documenting that any equipment or ancillary systems are properly installed, work correctly, actually leads the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.

Types of validation

Process validation
Analytical method validation
Cleaning validation
Facility validation
Utility validation & software validation

Process validation and types of process validation

Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducible to produce an intermediate / API meeting its pre-determined specifications and quality attributes.

Process validation is three types:

1. Prospective process validation

2. Concurrent process validation

3. Retrospective process validation

Prospective process validation:

Prospective Process validation shall be carried out for all the intermediate stages and Active Pharmaceutical Ingredients prior to the distribution of a new product. [ICH: GMP, EU: GMP, PIC/S: GMP]

Concurrent process validation:

Any validated process undergoes a change either for the equipment or addition, deletion of a critical manufacturing process step, scale up or scale down, the same needs to be validated concurrently.

The validation is carried out only after a change of an existing validated process to support the change made or involve with the requirements.

A subset 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

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 and control data. [ICH: GMP, EU: GMP, PIC/S: GMP]

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7. What do you mean by validation protocol and its contents of process validation?

A written plan stating, how validation will be conducted and defining acceptance criteria

e.g.: The protocol for manufacturing process identifies process equipment, 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 equipment’s 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 program

· Data to be complied

· Acceptance criteria

· Intermediate & final products quality & yield

· Stability specification

· Document review

· Conclusion

· Revalidation criteria

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8. 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 (Reference: ICH Q7A).

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.

· Documents required describing the quality system requirements in the organization.

· Documents required describing the process or product characteristics.

· Documents required by various regulatory agencies as part of compliance to GMP requirements.

· Documents 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 production procedures, instructions and records, quality control procedures and recorded test results involved in the manufacturing of a medicinal product

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Pharmaceutical Interview Questions - 1