Que 1: What is the definition of Qualification?
Answer: Qualification is the action of proving and documenting that any equipment or ancillary systems are properly installed, work correctly, actually show the expected results.
Qualification is part of validation, but the individual qualification steps alone do not
constitute process validation.
Que 2: Definition of process validation and types of process validation?
Answer: 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:
Retrospective process validation
Prospective process validation
Concurrent process validation
Que 3: What is the prospective, concurrent and retrospective validation?
Answer:
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. This validation is carried out
only after a change of an existing validated process to support the change made or
involve with the requirements.
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]
Que 4: What do you mean by validation protocol and its contents of process
validation?
Answer: 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.
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
Training record
Conclusion
Revalidation criteria
Que 5: What is the master document?
Answer: 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.
Que 6: What are the types of different training programs?
Answer:
Induction training
Job oriented training
cGMP training
On-going training
Que 7: What are the classifications of residual solvents?
Answer: Residual solvents are classified into three class based on the possible risk to human
health:
Class-III (Solvents with low toxic potential)
Class-I (Solvents to be avoided)
Class-II (Solvents to be limited)
Que 8: Write the names of the different countries regulatory body.
Answer:
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)
Bangladesh – DGDA
Philippines – BFAD (Beaureu of Food & Drug)
Que 9: What is the different types of Qualifications and write its flow?
Answer: Qualifications are as follows: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.
URS/DS —–FAT—–SAT—–DQ—–IQ—–OQ—–PQ
Que 10: What is audit/inspection and Why quality audit? Write different
types of audits/inspection?
Answer: 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:
Process based inspection
Study/test-based inspection
Facility based inspection
You Can Also Read:
Interview Questions and Answers for Pharmaceutical (Part 1)
Interview Questions and Answers for Pharmaceutical (Part 2)
Interview Questions and Answers for Pharmaceutical (Part 3)
Interview Questions and Answers for Pharmaceutical (Part 4)
Interview Questions and Answers for Pharmaceutical (Part 5)
Interview Questions and Answers for Pharmaceutical (Part 6)
