CPGP Sample Questions & Answers
Quality systems carry the biggest share, ahead of sterile and nonsterile manufacturing, lab systems, filling and packaging, global GMP regulatory governance tied with facilities, utilities and equipment and materials and supply chain, and product development.
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- Question 1Beginner
Regulatory Agency Governance · Site Master File (SMF), Validation Master Plan (VMP), Drug Master File (DMF), and Site Reference File (SRF)
True or False: A Validation Master Plan (VMP) provides a high-level overview of a specific site's GMP manufacturing operations, whereas a Site Master File (SMF) details the specific validation approach, protocols, and schedules for facilities, utilities, and equipment.
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Correct answer: B
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.
- Question 2Intermediate
Regulatory Agency Governance · Regulatory agency reporting
A pharmaceutical company is launching a new drug with known risks of severe birth defects. The regulatory agency mandates a program to ensure that the benefits of the drug outweigh its risks, requiring prescribers and pharmacies to be specially certified. This requirement is an example of which of the following?
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Correct answer: D
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.
- Question 3Intermediate
Quality Systems · Risk management and assessment
When applying ICH Q9 principles to evaluate the risks associated with implementing a new automated visual inspection machine, a cross-functional team utilizes Failure Mode and Effects Analysis (FMEA). The team calculates a Risk Priority Number (RPN) for each identified failure mode. What are the three factors evaluated to calculate the RPN?
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Correct answer: B
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.
- Question 4Advanced
Quality Systems · Risk management and assessment
The FDA's Quality Management Maturity (QMM) program encourages pharmaceutical manufacturers to move beyond basic cGMP compliance. Which of the following best represents a characteristic of a site operating with high Quality Management Maturity?
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Correct answer: A
Quality Management Maturity (QMM) is the state achieved when a pharmaceutical manufacturer consistently and reliably meets product quality and supply commitments. High QMM is characterized by a strong, proactive quality culture, cross-functional engagement, the use of advanced analytics for predictive modeling, and a focus on continual improvement rather than just reactive compliance to cGMP minimums.
- Question 5IntermediateSelect 2
Quality Systems · Investigations and corrective and preventive action (CAPA)
A pharmaceutical site is analyzing its Quality Management System data to identify trends that should trigger a formal Corrective and Preventive Action (CAPA). According to ICH Q10 and GMP expectations, which TWO of the following scenarios should mandate the initiation of a formal CAPA? (Select TWO)
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Correct answers: A, E
CAPAs should be initiated for systemic issues, significant deviations, or adverse trends that pose a risk to product quality. A gradual drift in dissolution times identified during an APR represents a systemic adverse trend requiring root cause analysis and preventive action. A confirmed critical product complaint regarding lack of efficacy also mandates a formal CAPA to investigate potential manufacturing or formulation defects. Isolated, easily correctable human errors or routine preventive maintenance findings typically do not require a full formal CAPA unless they become recurrent trends.
CAPAs should be initiated for systemic issues, significant deviations, or adverse trends that pose a risk to product quality. A gradual drift in dissolution times identified during an APR represents a systemic adverse trend requiring root cause analysis and preventive action. A confirmed critical product complaint regarding lack of efficacy also mandates a formal CAPA to investigate potential manufacturing or formulation defects. Isolated, easily correctable human errors or routine preventive maintenance findings typically do not require a full formal CAPA unless they become recurrent trends.
- Question 6Beginner
Quality Systems · Documents and records management
During a routine internal audit, a Quality Assurance auditor notices that a manufacturing operator is recording temperature values on a piece of scrap paper and entering them into the official batch record at the end of the shift. Which specific ALCOA+ principle of data integrity is being directly violated in this scenario?
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Correct answer: B
The ALCOA principle of 'Contemporaneous' requires that data be recorded at the exact time the action or observation takes place. Recording data on scrap paper and transcribing it later at the end of a shift violates this principle, as it introduces the risk of memory errors, loss of the original scrap paper, and obscures the true time the event occurred.
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