Free CPGP sample questions

Correct answer: The FDA will rely on the ANSM's inspection factual findings but retains the authority to determine if the facility meets US specific requirements and may request the full inspection report.

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.

Correct answers: Warning Letter; Consent Decree

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.

Correct answer: Level 3 change; reportable via a Prior Approval Supplement (PAS) because it involves a site change, a massive scale-up, and a change in equipment operating principle for a modified-release product.

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.

Correct answer: False

The statement has the definitions reversed. A Site Master File (SMF) provides a high-level overview of a site's GMP manufacturing operations, quality management system, and facility layout. A Validation Master Plan (VMP) details the specific validation approach, protocols, schedules, and responsibilities for qualifying facilities, utilities, equipment, and processes.

Correct answer: Risk Evaluation and Mitigation Strategy (REMS)

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. It often includes Elements to Assure Safe Use (ETASU), such as requiring prescribers, pharmacies, and patients to be enrolled in a special certification registry.

Correct answer: Severity, Occurrence, and Detection

In a Failure Mode and Effects Analysis (FMEA) under ICH Q9, the Risk Priority Number (RPN) is a quantitative measure calculated by multiplying three factors: Severity (S) of the effect, Occurrence (O) or probability of the cause happening, and Detection (D) or likelihood that current controls will catch the failure before it impacts the patient. RPN = S × O × D.