11. 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
12.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. 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]
13.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.
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 product quality & yield
Stability specification
Document review
Training record
Conclusion
Revalidation criteria
14.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).
15.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.
16.What are the types of different training programs?
1. Induction training
2. Job oriented training
3. cGMP training
4. On-going training
17. Write the names of the different countries regulatory body.
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)
18. 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. Firefighting 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
19.What is the different types of Qualifications and write its flow?
Qualifications are as follows: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.
URS/DS-FAT-SAT-DQ-IQ-OQ-PQ
20. 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
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