Quality Assurance and Regulatory Compliance
What the domain tests
Quality Assurance and Regulatory Compliance tests the systems that keep product release defensible: GMP regulations, ICH guidance, deviation and CAPA management, change control, batch record review, and data integrity. The exam rewards knowing which requirement is mandatory and which is guidance, and how to write an investigation that stands up to inspection.
Core rules
- ICH Q7 governs active pharmaceutical ingredients; ICH Q10 describes the pharmaceutical quality system; 21 CFR 210/211 and EU GMP Chapters 1–9 govern finished products. Annex 1 adds aseptic requirements.
- A deviation is a departure from an approved procedure or specification. It needs immediate containment, impact assessment, root-cause investigation, CAPA, and an effectiveness check. “Retrain operator” is not a root cause.
- Change control must assess impact on regulatory filings, validation state, stability, and other products. Like-for-like equipment replacement may still require qualification if materials or dimensions change.
- Data integrity follows ALCOA+: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available. Audit trails must be reviewed.
- Batch record review must be independent and complete before release; unresolved deviations block release.
Worked example
A tablet batch has assay 94.0% against a 95.0–105.0% specification. The analyst repeats the test and gets 94.2%. The correct sequence is a laboratory investigation first: check standard preparation, dilution, instrument suitability, and sample handling. If no lab error is found, escalate to a manufacturing investigation covering blend uniformity, granulation endpoint, compression weight, and assay method transfer. Do not average results or retest until passing. If the root cause is a verified weighing error, the batch may be rejected or reworked only under an approved protocol with impact assessment. The reasoning is that an out-of-specification result is a decision point, not a nuisance.
Traps
- Treating “human error” as a root cause without identifying the system failure.
- Closing a CAPA without an effectiveness check.
- Changing a specification to match results.
- Assuming electronic records are compliant without audit-trail review.