SQA Validation and Qualification Flashcards

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

Answer: Process Design, Process Qualification, and Continued Process Verification

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

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

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

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

What is Operational Qualification (OQ) in equipment qualification?

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

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

What is Performance Qualification (PQ)?

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

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

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

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

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

What is 'prospective validation' in pharmaceutical manufacturing?

Answer: Validation completed before a new process is used for commercial production

Prospective validation is completed before commercial manufacturing begins, demonstrating through pre-planned studies that the process will consistently produce a product meeting specifications.