Free Certified Pharmaceutical GMP Professional Practice Questions

Sample Practice Questions

Try these 10 sample questions from the Certified Pharmaceutical GMP Professional practice bank. Each includes the answer and explanation. Continue with the interactive practice above to review the full question set.

1. 1Which U.S. statute established FDA authority in 1938 to require evidence of safety for new drugs?

   1. A. The Federal Food, Drug, and Cosmetic Act
   2. B. The Public Health Service Act
   3. C. The Controlled Substances Act
   4. D. The Federal Anti-Tampering Act

   Answer: A

   Explanation: FDA states, "Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections." The passage identifies the 1938 FD&C Act. The other statutes address different statutory authorities rather than this 1938 requirement.

   Reference: Laws Enforced by FDA — Congressional milestones

2. 2An ICH Q10 quality-system proposal contains procedures and an organization chart but no way to monitor whether its processes work. Which addition addresses this design gap?

   1. A. Count the controlled procedures issued during each quarter
   2. B. Track attendance at scheduled quality-system training sessions
   3. C. Record whether each department has an approved written procedure
   4. D. Monitor quality-system process outcome and effectiveness indicators

   Answer: D

   Explanation: ICH Q10 states, "Performance indicators, as described in section V (4), should be identified and used to monitor the effectiveness of processes within the pharmaceutical quality system." Procedure counts, attendance, and procedure existence document activities or implementation. Outcome and effectiveness indicators address whether those processes work.

   Reference: Q10 Pharmaceutical Quality System — Printed page 5, Design and Content Considerations, performance-indicator paragraph

3. 3A laboratory adopts an unmodified method from the current USP for testing a drug product. What must still be verified under 21 CFR 211.194(a)(2)?

   1. A. Suitability of the method under actual conditions of use
   2. B. Only that the cited compendial revision is the current one
   3. C. Only that one reference-standard injection passes system suitability
   4. D. That every original validation experiment has been repeated in full

   Answer: A

   Explanation: Section 211.194(a)(2) states, "The suitability of all testing methods used shall be verified under actual conditions of use." Checking the edition or one standard response alone does not establish suitability for actual samples and conditions. The provision permits a method reference for an unmodified compendial method; it does not impose blanket repetition of every original validation experiment.

   Reference: 21 CFR Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals — 21 CFR 211.194(a)(2), printed p. 180

4. 4Under 21 CFR 211.42(d), how must facilities for manufacturing, processing, and packing penicillin relate to facilities for other human drug products?

   1. A. They may share the same facilities if final-product testing passes
   2. B. They may share the same facilities if campaigns occur on different days
   3. C. They must be separate from facilities used for the other human drugs
   4. D. They must be separate only for packing, while manufacturing may be shared

   Answer: C

   Explanation: Section 211.42(d) states that penicillin operations "shall be performed in facilities separate from those used for other drug products for human use." Scheduling or passing final tests does not replace the required separation of the listed operations.

   Reference: 21 CFR Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals — 21 CFR 211.42(d), printed p. 163

5. 5A warehouse receives containers of a drug component. Before accepting them under 21 CFR 211.82(a), what visual examination is required?

   1. A. Confirm the shipment quantity without examining the containers
   2. B. Check labeling, container damage or broken seals, and contamination
   3. C. Check the shipping invoice and defer container examination until dispensing
   4. D. Inspect only containers whose supplier has previously failed an audit

   Answer: B

   Explanation: Section 211.82(a) requires visual examination for "appropriate labeling as to contents, container damage or broken seals, and contamination." Counting units or relying on supplier history does not replace examining the received containers or groupings before acceptance.

   Reference: 21 CFR Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals — 21 CFR 211.82(a), printed p. 166

6. 6Under 21 CFR 211.186(a), which preparation and checking arrangement is required for master production and control records?

   1. A. One person prepares and signs; a second independently checks and signs
   2. B. One person prepares and signs; the same person independently rechecks
   3. C. Production prepares an unsigned master; operators approve it during use
   4. D. A second person checks only after the first batch has been distributed

   Answer: A

   Explanation: Section 211.186(a) requires masters to be prepared, dated, and signed by one person and "independently checked, dated, and signed by a second person." Self-review, unsigned authorization, or review after distribution does not provide that independent master-record control.

   Reference: 21 CFR Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals — 21 CFR 211.186(a), printed p. 178

7. 7An aseptic filling line needs to maintain weight monitoring during filling while reducing repeated manual activity in the critical area. Which design change does FDA identify for this objective?

   1. A. Add more manually performed weight checks within the critical area
   2. B. Integrate an online weight-check device into the filling line
   3. C. Move the manual weighing station to another point inside the critical area
   4. D. Require a second operator to repeat each manual critical-area weight check

   Answer: B

   Explanation: FDA states, "personnel intervention can be reduced by integrating an on-line weight check device, thus eliminating a repeated manual activity within the critical area." The online device retains weight monitoring while reducing manual intervention. More checks, another critical-area location, or duplicate manual checks do not eliminate that repeated activity.

   Reference: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice — Section IV.E, Design

8. 8Development studies show that a drug product's impurity concentration must remain below an established limit to ensure the desired quality. How is that concentration classified in ICH Q8(R2)?

   1. A. A critical process parameter
   2. B. A quality target product profile
   3. C. A critical quality attribute
   4. D. A manufacturing design space

   Answer: C

   Explanation: ICH Q8(R2) states, "A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality." The impurity concentration is a chemical quality property. A process parameter is an input to processing, a target product profile summarizes intended product characteristics, and design space describes demonstrated combinations of inputs.

   Reference: Q8(R2) Pharmaceutical Development — Printed page 12, Annex—Critical Quality Attributes, definition paragraph

9. 9Which amendments required drug manufacturers to demonstrate effectiveness, strengthening the earlier U.S. drug safety framework?

   1. A. The Durham-Humphrey Amendments
   2. B. The Kefauver-Harris Amendments
   3. C. The Hatch-Waxman Amendments
   4. D. The Medical Device Amendments

   Answer: B

   Explanation: FDA explains that the Kefauver-Harris Amendments "strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness." This distinguishes the efficacy requirement from prescription classification, generic-drug approval pathways, and device regulation.

   Reference: Laws Enforced by FDA — Congressional milestones: Kefauver-Harris Amendments

10. 10Under ICH Q10, who has ultimate responsibility for ensuring that an effective pharmaceutical quality system is in place?

    1. A. The company's senior management
    2. B. The external contract laboratory director
    3. C. The assigned regulatory inspection team
    4. D. The site's independent quality-unit head

    Answer: A

    Explanation: ICH Q10 states, "Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives". The site quality unit has important operating responsibilities, and inspectors and contractors have their own roles, but those roles do not replace senior management’s ultimate accountability.

    Reference: Q10 Pharmaceutical Quality System — Printed page 5, Management Commitment, senior-management responsibility paragraph