SQA SQA Validation and Qualification

Question 1

What are the three stages of FDA's current process validation lifecycle framework (2011 Guidance)?

Accepted Answer

Process Design, Process Qualification, and Continued Process Verification

Answer

Installation, Operational, and Performance Qualification

Answer

Phase I, Phase II, and Phase III validation studies

Answer

Prospective, Concurrent, and Retrospective Validation

Question 2

What is Installation Qualification (IQ) for a piece of equipment?

Accepted Answer

Documented verification that equipment is installed correctly according to manufacturer specifications and design intent

Answer

Testing that the equipment operates within its full operational range

Answer

Confirming the equipment consistently produces output within specifications

Answer

Training operators on how to use the equipment safely and correctly

Question 3

What is Operational Qualification (OQ) in equipment qualification?

Accepted Answer

Documented testing that equipment operates within its defined operating ranges across all intended operating conditions

Answer

Verifying that equipment is physically installed correctly per manufacturer specifications

Answer

Confirming the equipment produces product consistently within acceptance criteria

Answer

Ensuring operators are fully trained before they begin using the equipment

Question 4

What is Performance Qualification (PQ)?

Accepted Answer

Documented evidence that equipment consistently performs in accordance with specifications under actual or simulated production conditions

Answer

Testing equipment performance using non-product surrogate materials before IQ begins

Answer

A vendor review of qualification documentation to verify completeness

Answer

Annual recalibration of critical instruments to confirm continued accuracy

Question 5

What is the purpose of a Validation Master Plan (VMP)?

Accepted Answer

To provide a high-level overview of the validation program, scope, responsibilities, approach, and schedule for a facility

Answer

To list every individual test case for a specific validation study

Answer

To document the results of all completed validation activities in one place

Answer

To submit validation plans to the FDA for pre-approval before execution

Question 6

What is 'prospective validation' in pharmaceutical manufacturing?

Accepted Answer

Validation completed before a new process is used for commercial production

Answer

Validation performed during actual commercial production of product batches

Answer

Validation based entirely on historical data from previously manufactured batches

Answer

Validation required specifically after a significant process deviation has occurred