Most Frequently Asked Question In Pharmacy Interview

1. What is the definition of SOP ?

Ans; 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 equipments 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.

2 What are the contents of the SOP ?
Ans; Objective/Purpose, Scope, Responsibility, Accountability, Procedure, List of formats/Annexure, Abbreviations, Reference, Revision History

Which information should master document carry on every page not just one of the pages to meet GMP?
Ans; Page number, document reference number and authorizing signatures

4 How many SOPs required for equipment and what are those ?
Ans; Operation, Cleaning, Preventive maintenance/ Calibration, Sampling procedure.

5 What is the Batch production and control record (BPCR)?
Ans; 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.

6 What is the Master production & control record (MPCR)?
Ans; 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.

7 What are the 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:
  -Sequences to be followed
 – ranges of process parameters to be used
 –sampling instructions and in-process controls with their acceptance criteria, where appropriate

8 What is the list SOPs required in QA department?
Ans; 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.

What is the difference between intermediate and drug substance (API)?
Ans; 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).

10 What is the difference between drug substance and drug product?
Ans; 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).

11 What is the clean room?
Ans; Clean rooms are defined as especially constructed, environmentally controlled enclosed spaces with respect to airborne particulates, temperature, humidity, air pressure, air flow patterns, air motion, vibration, noise, viable (living organisms) and lighting. Particulate control includes:
  • Particulate & microbial contamination
  • Particulate concentration & dispersion

12 What are the classifications of clean rooms?

 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
Britian (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

13. 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.
14. What is the difference between Qualification and Validation?
Qualification is equipment / instrument oriented but validation is process oriented
15. What is the definition of Validation?
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.
16. What is the definition of Qualification?
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.
17. What are the types of validation?
Process validation, Analytical method validation, cleaning validation, facility validation, Utility validation & software validation.
18. Definition of process validation and types of process validation?
Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly 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
19. What is the prospective, concurrent and retrospective 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.
20. 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 equipments, critical process parameters, and / or operating range, product characteristics, sampling, test data to be collected, number of validations runs and acceptance test results.
 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 (Reference: ICH Q7A).
22. 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
* Documents required for legal/ regulatory supports of the organization to meet the local regulations.
* Any other documents required by government / regulatory agency.
23. 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.
24. What is the Technology Transfer?
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to fullscale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the technology.
To assure the drug quality, it is desire to make sure 5 W’s and 1 H, that is what1, when2, and why3 information should be transferred to where4 and by whom5 and how to transfer, then share knowledge and information of the technology transfer each other between stake holders related to drug manufacturing.
25. What are the names of different countries of GMP guidelines for manufacturing of API?
WHO GMP – Geneva
ICH Q7A – Europe, Japan & US
EU GMP – Europe
MCC – South Africa
APIC GMP – Active Pharmaceutical Ingredient Committee (A sector group of CEFIC)
USFDA GMP – United States of America
PIC/S GMP- Germany
Schedule M – Indian
26. What is preventive maintenance?
It is periodic inspection and minor repairs of equipment as per schedule given in the SOP. This enables smooth operation and long life of the equipment. It also avoids major breakdown of the equipment during manufacturing of the product.
There are two types of maintenance.
Preventive maintenance: Schedule maintenance before any break down of machinery which prevents the machine break down.
Breakdown maintenance: Maintenance was done after stopping machine breakdown. Weekly, Monthly, Quarterly, Half yearly and Yearly preventive maintenance
27. What do you mean by “Quality Assurance”?
The sum total of the organized arrangements made with the objects of ensuring that all APIs are of the quality required for their intended use and the quality systems are maintained.
28. What are the types of different training programs?
1. Induction training
2. Job oriented training
3. cGMP training
4. On-going training
29. What is 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.
30. What are the requirements for the equipment used in the manufacturing of process of API?
Material of construction used for equipment should not
  •  React with component
  •  Get corroded, cause rusting
  •  Impart any impurities, absord
  • Should be of appropriate design, adequate size and have smooth surface
31. How are cGMP implemented?
Training, compliance to SOPs, control on operations, following procedures / systems, monitoring through compliance audits.
32. What is solvent?
An organic or inorganic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacturing of an intermediate / API.
33. What are the classifications of residual solvents?
Residual solvents are classified into three class based on the possible risk to human health:
Class-I (Solvents to be avoided)
Class-II (Solvents to be limited)
Class-III (Solvents with low toxic potential)
34. What is the difference between Responsibility and Accountability?
Responsibility: Personnel directly associated with the implementation of the procedure
Accountability: Person directly associated with the implementation of the system under which the procedure falls.
35. Write the names of the different countries regulatory body (Like for India, USA, UK, Australia, South Africa, Brazil, Hungary, Germany, Philippines etc.)
United Status of America – USFDA (United state Food and Drug Administration)
Australia – TGA (Therapeutic Goods Administration)
United Kingdom – MHRA (Medicines & Health care products Regulatory Agency)
South Africa – MCC (Medicine Control Council)
Brazil – ANVISA (Brazilian Health Surveillance Agency or National Sanitary Surveillance Agency)
Hungary – PIC/S (Pharmaceutical Inspection Convention or Pharmaceutical Inspection Cooperation Scheme)
Germany – NIP (National Institute of Pharmacy)
Philippines – BFAD (Beaureu of Food & Drug)
36. What is the abbreviation of MSDS and how many contents are mentioned & what are those?
MSDS means Material Safety Data Sheet and it contains 16 contents. Those are given below:
1. Product Identification
2. Composition / Information on Ingredients
3. Hazards identification
4. First Aid measures
5. Fire fighting measures
6. Accidental release measures
7. Handling & storage
8. Exposure controls / Personal protection
9. Physical & Chemical properties
10. Stability & Reactivity
11. Toxicological information
12. Ecological information
13. Disposal consideration
14. Transport information
15. Regulatory information
16. Other information
37. What is the static electricity?
Denoting / pertaining to electricity which is at rest. The electricity which is present on surface of a non-conductive body, where it is trapped from escaping, is called static electricity.
38. What is the different types of Qualifications and write its flow?
Qualifications are as follows: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.
39. What is audit/inspection and Why quality audit? Write different types of audits/inspection?
A planned and systematic examination and check of a system, procedure or operation in order to monitor compliance with and the effectiveness of established standards and to allow for improvement and corrective measures where required.
Quality audit because of:
  • To assess the effectiveness of the quality management system
  • Assessing conformance
  • 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.

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