10 free, exam-style Certified Pharmaceutical GMP Professional (CPGP) practice questions with answers and explanations. No signup required. Work through them below, then take the full free CPGP practice test to study every exam domain.
During a deviation investigation, a firm finds that an out-of-specification assay result was caused by a balance whose calibration had lapsed. The firm reweighs and reprocesses the affected batch, recalibrates the balance, and then revises its SOP to add automated calibration-due alerts for all balances on site. Which of these is the CORRECTIVE action?
Correct answer: C - Revising the SOP to add automated calibration-due alerts for all balances
A QC analyst obtains an out-of-specification (OOS) assay result for a finished product batch, and no obvious error was observed during testing. According to FDA guidance on investigating OOS results, what is the appropriate FIRST step?
Correct answer: B - Conduct a laboratory investigation to identify any assignable cause
A new sterile injectable product is both heat-stable and chemically stable at sterilization temperatures. When selecting a sterilization approach, which method should generally be preferred, and why?
Correct answer: A - Terminal sterilization, because the product is sterilized within its final sealed container
A tablet compression process has an upper specification limit (USL) of 520 mg, a lower specification limit (LSL) of 480 mg, a process mean of 505 mg, and a standard deviation of 5 mg. What is the process capability index (Cpk)?
Correct answer: B - 1.00
During a data integrity review, an auditor finds that a QC analyst recorded several test results at the end of the shift - hours after the tests were actually performed - rather than at the time each test was completed. Which ALCOA+ principle is MOST directly violated?
Correct answer: C - Contemporaneous
A newly installed lyophilizer has passed its installation checks and has been verified to operate correctly across its full range of settings. Before routine use, the firm runs the unit with actual product loads under defined production conditions to confirm it consistently performs as intended. This final activity is BEST described as:
Correct answer: D - Performance Qualification (PQ)
A batch of tablets fails content uniformity testing, and the investigation traces the cause to under-mixed granulation. The firm proposes to re-mill and re-blend the granulation using a step that is already part of the approved, validated manufacturing process. This activity is BEST classified as:
Correct answer: D - Reprocessing, since the step is part of the established process
At the end of a packaging run, label reconciliation shows that the quantity of labels issued does not equal the quantity used plus those returned and destroyed, leaving an unexplained shortfall of 250 labels. What is the MOST appropriate action?
Correct answer: A - Investigate the discrepancy before releasing the batch for distribution
A firm discovers that a distributed lot of an oral tablet has a labeling error that could cause temporary, medically reversible harm, with only a remote probability of serious adverse consequences. Under FDA recall classifications, this is MOST likely:
Correct answer: B - Class II
During pharmaceutical development of a tablet, the dissolution rate is identified as a property that must remain within a defined range to ensure the product is safe and effective. In Quality by Design (QbD) terminology, the dissolution rate is BEST described as a:
Correct answer: C - Critical Quality Attribute (CQA)
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