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

The FDA's 2011 Process Validation Guidance describes three stages: Stage 1 (Process Design), Stage 2 (Process Qualification), and Stage 3 (Continued Process Verification).

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

IQ documents that equipment is properly installed including utilities, safety features, and compliance with design specifications before operational testing begins.

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

OQ tests and documents that equipment functions as intended across its full operating range, often including worst-case conditions, before process-specific performance testing.

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

PQ demonstrates that equipment performs reliably under actual or simulated production conditions using the real process, product, and personnel — the final qualification phase.

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

A VMP is a planning document that describes the overall strategy, organization, scope, and priorities for the validation program of a facility or company.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA SQA Validation and Qualification