CPGP Practice Questions
Prepare for CPGP with more than an answer.
- Level
- Professional
- Valid for
- 3 years
Domains covered on the exam 8
- Regulatory Agency Governance11.33%
- Quality Systems17.33%
- Laboratory Systems13.33%
- Infrastructure: Facilities, Utilities, and Equipment11.33%
- Materials and Supply Chain Management11.33%
- Sterile and Nonsterile Manufacturing Systems14.67%
- Filling, Packaging, and Labeling12%
- Product Development and Technology Transfer8.67%
- 1
Company Alpha, an innovator pharmaceutical firm, outsources the manufacturing and release testing of its commercial biologic to Company Beta (a CMO). An out-of-specification (OOS) result occurs during the final release testing at Beta's laboratory.
Beta performs a Phase I laboratory investigation, finds no assignable root cause, and initiates a Phase II manufacturing investigation. Beta subsequently determines the batch must be rejected. Alpha disputes this, claiming Beta's lab equipment was faulty, and demands the batch be released.
According to GMP principles regarding outsource processes and quality agreements, how should this dispute be resolved?
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Correct answer: B
In outsourced manufacturing, the Quality Agreement is the critical document that delineates the responsibilities of the Contract Giver (Alpha) and Contract Acceptor (Beta). It must explicitly detail procedures for handling OOS results, conducting investigations, dispute resolution, and final batch disposition. While the Contract Giver usually retains ultimate responsibility for the product on the market, the Quality Agreement dictates how such technical and quality disputes are managed, often requiring mutual agreement or independent third-party testing before disposition, but never allowing one party to simply overrule the other's validated OOS finding without proper scientific justification outlined in the agreement.
- 2
While both the US Annual Product Review (APR) and the EU Product Quality Review (PQR) serve to verify the consistency of existing processes and the appropriateness of current specifications, there are distinct differences between them. Which of the following is a specific requirement of the EU PQR that is NOT explicitly mandated by the US APR?
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Correct answer: B
The EU Product Quality Review (PQR) per EudraLex Volume 4, Chapter 1 explicitly requires a review of the qualification status of relevant equipment and utilities, e.g., HVAC, water, compressed gases, etc., as well as a review of technical agreements. The US FDA Annual Product Review (APR) per 21 CFR 211.180(e) focuses more strictly on product data (complaints, recalls, returns, OOS, and process changes) and does not explicitly mandate reviewing equipment/utility qualification status within the APR report itself.
- 3
After a manufacturer upgrades the firmware on a critical tablet press, the change control process dictates a post-change analysis phase. What is the primary purpose of this post-change analysis?
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Correct answer: B
The post-change analysis (often called an effectiveness check) is a critical component of the change management lifecycle. Its purpose is to review data after the change has been implemented to verify that the change achieved its intended goal (e.g., improved reliability) and to ensure that no new, unintended risks or adverse effects on product quality or process performance were introduced.
- 4
A multinational pharmaceutical manufacturer is exporting an active pharmaceutical ingredient (API) from a facility in France to the United States. During a recent system-based inspection by the ANSM (French regulatory agency), the facility received a GMP certificate. Under the US-EU Mutual Recognition Agreement (MRA), how will the FDA treat this inspection outcome?
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Correct answer: B
Under the US-EU MRA, the FDA and EU recognize each other's GMP inspections of pharmaceutical manufacturing facilities. However, the regulatory authority retains the right to make its own final determination regarding compliance with its specific market requirements. The FDA relies on the factual findings of the recognized authority (ANSM) but does not blindly accept the certification without reserving the right to review the inspection report if needed.
- 5
Following a highly critical FDA inspection, a pharmaceutical company receives a formal notification indicating that the agency intends to seek an injunction if severe GMP violations are not immediately corrected. Which TWO of the following enforcement actions or documents are associated with this level of escalation? (Select TWO)
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Correct answer: B, C
A Warning Letter is a formal notification from the FDA that identifies serious regulatory violations. It warns the company that failure to take immediate corrective action may result in further enforcement actions, such as an injunction or seizure. A Consent Decree is a legal agreement (often following an injunction) overseen by a federal court that forces a company to commit to GMP compliance. Form 483 is merely a list of inspectional observations, not a formal enforcement escalation. EIR is an Establishment Inspection Report.
A Warning Letter is a formal notification from the FDA that identifies serious regulatory violations. It warns the company that failure to take immediate corrective action may result in further enforcement actions, such as an injunction or seizure. A Consent Decree is a legal agreement (often following an injunction) overseen by a federal court that forces a company to commit to GMP compliance. Form 483 is merely a list of inspectional observations, not a formal enforcement escalation. EIR is an Establishment Inspection Report.
- 6
Company X manufactures a modified-release solid oral dosage form. The company plans to move the manufacturing of this product to a newly constructed facility located 50 miles away. At the same time, they will be scaling up the batch size by 15x and changing the operating principles of the fluid bed granulator.
Based on SUPAC (Scale-Up and Post-Approval Changes) guidances, how must the regulatory affairs specialist categorize this post-marketing change, and what is the required reporting method?
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Correct answer: C
Under FDA SUPAC guidelines, changing the manufacturing site to a different campus, scaling up beyond a 10x factor, and changing the operating principle of critical equipment (like a fluid bed granulator for a modified-release product) all independently qualify as Level 3 changes. Level 3 changes have a significant potential to impact product quality and require a Prior Approval Supplement (PAS). The company must wait for FDA approval before distributing the product manufactured under the new conditions.
