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These 10 free cGMP Problem-Solving questions are organized by exam domain, so you can see how each part of the BCSI cGMP Problem-Solving blueprint is tested. Reveal the answer and explanation under each question.
Bottle leaks began after a cap-lot change and servicing of capping head B. An approved off-line comparison uses the same technician, matched settings, and 40 bottles for each head/lot combination. Leak-test controls pass. Old cap lot: head A, 0 leaks; head B, 8 leaks. New cap lot: head A, 0 leaks; head B, 9 leaks. The evidence points most strongly to:
Correct answer: C - A condition specific to head B is contributing to the seal failures.
Balance B-6 passes its daily check at 07:00. It is then used to dispense components for lots R21 at 08:30, R22 at 10:40, and R23 at 13:15. At 15:00, the balance fails the same check and is removed from use. There were no intervening checks, and the time the error began is unknown. No other lots used B-6 that day. What is the defensible initial scope of the product-impact investigation?
Correct answer: B - All three lots, assessing their potential exposure without declaring them defective.
A pH meter repeatedly reads 7.21, 7.22, and 7.21 when checking a fresh certified buffer whose assigned value is 7.00 at the test temperature. An independently verified meter reads 7.00 for the same buffer. The approved check tolerance is plus or minus 0.05 pH unit. What do these observations show about the first meter?
Correct answer: B - Good repeatability with an unacceptable positive bias; investigate the system before routine use.
At 14:20, a technician notices that a required pH field in the paper batch record is blank. The retained instrument record identifies the correct batch, the technician, a 09:10 acquisition time, and an acceptable result. Only the required transcription was missed. How should the technician complete the paper record?
Correct answer: A - Enter the result as a signed, dated 14:20 late entry referencing the 09:10 record and explaining the omission.
A laboratory is retiring a chromatography system while its records are still within their retention period. The proposed archive contains PDF chromatograms and final results, but no processing history, audit trails, or files that allow the original analyses to be reconstructed. A visual check confirms that every PDF matches its displayed report. What must be addressed before the original system is decommissioned?
Correct answer: A - Retain retrievable electronic records with the raw data, processing history, and audit trails.
An unknown liquid leaks from a drum in a dispensing room. A technician develops throat irritation while an unobstructed exit remains available. The technician is not trained for hazardous-spill response, and the batch record is still on a bench beside the drum. Which action takes priority?
Correct answer: B - Leave the room, warn others away, and activate the site emergency-response procedure.
During shift handover, the outgoing lead says, "Lots T14 and T15 are on hold. Quality must authorize either release." The incoming lead replies, "Understood: T14 stays on hold, and T15 can ship once its assay passes." Both holds are currently active in the inventory system. What should the outgoing lead say next?
Correct answer: A - "T15 also requires quality authorization. Please repeat what must happen before either lot can ship."
A filling process has a target of 100.0 g and an approved individual-fill specification of 98.0-102.0 g. All current samples comply, and the established control charts show no signals or drift. The latest readings fluctuate narrowly above and below target. A colleague proposes adjusting the filler after every reading so each subsequent fill lands exactly on 100.0 g. Which operating response is justified?
Correct answer: D - Maintain the established settings and continue approved sampling and process monitoring.
A finished-drug assay is 93.8% against an approved specification of 95.0-105.0%. The laboratory review finds no causative analytical error. Two retests performed under an authorized investigation plan give 98.6% and 99.0%. All results are retained, and the batch remains on hold. What is the next quality action?
Correct answer: C - Extend the investigation to production, sampling, and associated batches; retain the original OOS for the quality assessment.
A corrective action targets at least a 50% relative reduction in the percentage of changeovers with a label-selection error. Comparable observations show: Before implementation: 8 affected changeovers out of 200. Completed follow-up: 4 affected changeovers out of 50. The error definition and observation method are unchanged. The owner cites the lower error count as evidence of success. Which effectiveness finding is supported?
Correct answer: D - The rate doubled, from 4% to 8%; the effectiveness target was not met.
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