Test your knowledge of Good Manufacturing Practice and pharmaceutical quality assurance: data integrity (ALCOA+), ICH Q9 and Q10, CAPA, change control, OOS investigations and process validation. There are 15 questions. Click an answer to see whether you are right, with a short explanation.
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1.What does the data integrity acronym ALCOA stand for?
Answer: C. ALCOA means Attributable, Legible, Contemporaneous, Original and Accurate. ALCOA+ adds Complete, Consistent, Enduring and Available.
2.Which of these is NOT one of the four attributes added in ALCOA+?
Answer: C. The '+' adds Complete, Consistent, Enduring and Available. 'Approved' is not part of ALCOA+.
3.Which ICH guideline covers Quality Risk Management?
Answer: C. ICH Q9 (revised as Q9(R1)) describes quality risk management principles and tools such as FMEA and HACCP.
4.ICH Q10 describes which of the following?
Answer: A. ICH Q10 is the Pharmaceutical Quality System model, covering management responsibility, CAPA, change management and management review across the product lifecycle.
5.A preventive action in CAPA is taken to:
Answer: C. Corrective action eliminates the cause of an existing nonconformity. Preventive action addresses the cause of a potential nonconformity before it occurs. CAPA guide →
6.What is the main purpose of change control?
Answer: A. Change control makes sure proposed changes are assessed for their impact on quality, regulatory status and validation, and are approved before implementation.
7.Line clearance is performed:
Answer: A. Line clearance prevents mix-ups and cross-contamination by confirming that the line is free of the previous product's materials before the next operation starts.
8.Phase I of an OOS investigation mainly looks for:
Answer: D. Phase I is the laboratory investigation: analyst error, instrument problems, calculations and the standard/sample preparation. If no lab error is found, the investigation moves to a full-scale (Phase II) review. OOS guide →
9.'Testing into compliance' refers to:
Answer: D. Retesting until a passing result appears, and discarding the OOS result without a justified cause, is unacceptable. Regulators specifically criticise it. OOS guide →
10.Material under 'quarantine' status is:
Answer: A. Quarantine means the material is physically or systematically isolated pending a QC/QA decision to release or reject.
11.Which US regulation requires an annual review of the quality standards of each drug product?
Answer: B. 21 CFR 211.180(e) requires written records to be reviewed at least annually to evaluate the quality standards of each drug product. The EU equivalent is the Product Quality Review (EU GMP Chapter 1).
12.A planned deviation is:
Answer: D. Planned deviations are assessed and approved by QA before they happen and are limited in time or number of batches. Permanent changes go through change control.
13.In the EU, who certifies each batch before release for sale?
Answer: B. Under EU legislation and EU GMP Annex 16, a Qualified Person must certify each batch before it is released for sale or supply.
14.Stage 3 of the FDA 2011 process validation guidance is:
Answer: D. The three stages are 1 Process Design, 2 Process Qualification and 3 Continued Process Verification, which is ongoing assurance during routine production.
15.Which statement about good documentation practice is correct?
Answer: B. Entries must be contemporaneous and permanent. Corrections must leave the original legible, be signed and dated, and give a reason when required. Scrap-paper transcription and correction fluid breach data integrity.