Quality Assurance and Good Manufacturing Practice
What this domain tests
Quality Assurance and Good Manufacturing Practice tests whether you can operate a quality system that prevents contamination, mix-ups, and false release. Questions cover documentation, validation, deviations, CAPA, change control, audits, and data integrity.
Core rules
- QA is not QC. QC performs testing; QA oversees the system, approves procedures, investigates deviations, and ensures release decisions are defensible.
- GMP essentials: qualified facilities and equipment, trained personnel, approved procedures, validated processes, reliable documentation, and traceability from raw material to batch.
- Qualification and validation: DQ, IQ, OQ, PQ for equipment; process validation for manufacturing; cleaning validation; computer system validation. Validation is lifecycle-based, not a one-time report.
- Data integrity: ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available). Electronic records need audit trails, access control, and backup.
- Deviations and CAPA: contain the problem, investigate root cause, assess impact, implement corrective and preventive actions, and verify effectiveness before release.
- Change control evaluates proposed changes for regulatory and quality impact. Supplier qualification and audits extend control to the supply chain.
Worked example
A media fill shows contaminated units in a sterile filling simulation. The batch cannot be released merely because the final sterility test is negative. The investigation must review operator technique, airflow, equipment, and environmental monitoring; corrective actions may include retraining, HVAC repair, or line revalidation. Release waits until the root cause is addressed and the process is requalified. The reasoning is that a negative test does not prove sterility assurance.
Traps that cost marks
- Treating QA as a testing laboratory.
- Backdating or completing records after the fact.
- Validating once and never reviewing changes.
- Closing deviations without root cause.
- Releasing product during an open critical investigation.