20+ Quality Assurance Interview Questions and Answer | Latest QA Interview Questions and Answer | Pharma Grow

20+ Quality Assurance Interview Questions and Answer | Latest QA Interview Questions and Answer | Pharma Grow

Question :- Which is better QC or QA?
Answer :-  Quality Assurance Is Not Quality Control. ... The difference is that QA is process oriented and QC is product oriented. Testing, therefore is product oriented and thus is in the QC domain. Testing for quality isn't assuring quality, it's controlling it.

Question :- What is an SOP?
Answer :-  A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.

Question :- What is 21 CFR part 11?
Answer :-  Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records

Question :- What are user requirements?
Answer :-  User Requirements Specification describes what users require from the System. User requirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.

Question :- What is a validation plan?
Answer :-  Validation plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:

Deliverables (Documents) to be generated during the validation process
Resources / Departments / Personnel to participate in the validation project
Time-Line for completing the validation project

Question :-  What is an IQ document?
Answer :-  Installation Qualifications are a collection of test cases used to verify the proper installation of a System. The requirement to properly install the system was defined in the Design Specification. Installation Qualifications must be performed before completing Operational Qualification or Performance Qualification.

Question :- What is an OQ Document?
Answer :-  Operational qualifications are a collection of test cases used to verify the proper functioning of a system. The operational qualification tests requirements defined in the Functional Requirements. Operational qualifications are usually performed before the system is released for use.

Question :-  What is a PQ Document?
Answer :-  Performance qualifications are a collection of test cases used to verify that a system performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conducted with power users as the system is being released.

Question :-  What is a Validation Summary Report?
Answer :-  Validation summary reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include:

A description of the validation project
All test cases performed, including if those test cases passed without issue
All deviations reported, including how those deviations were resolved

Question :-  What is a Change Request?
Answer :-   Change control is a general term describing the process of managing how changes are introduced into a controlled system. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.



Question :-  How many parts are in 21 CFR?
Answer :-   This database includes a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.




Question :- What is GMP in pharma?
Answer :-  Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.




Question :-  What is the function of quality assurance department?
Answer :-  Quality assurance managers play a crucial role in business by ensuring that products meet certain thresholds of acceptability. They plan, direct or coordinate quality assurance programs and formulate quality control policies. They also work to improve an organization's efficiency and profitability by reducing waste.


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1. Quality Control Interview Questions & Answer | Quality Control Officer | Pharma Grow

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