ASQ Certified Pharmaceutical GMP Professional

QUESTION NO: 1
When assessing controls over supplier selection, what is considered a best practice?
Response:

A. Selecting suppliers based solely on cost B. Choosing suppliers based on geographic proximity only C. Relying on supplier self-assessment reports without verification D. Ensuring there are formal contracts or quality agreements in place

Correct Answer: D

QUESTION NO: 2
The Quality Unit should be independent from operations to avoid any _____.
Response:

A. cost reductions B. conflicts of interest C. efficiency improvements D. team collaborations

Correct Answer: B

QUESTION NO: 3
The outcome of the laboratory portion of an investigation into atypical results should determine the _______ for further investigation.
Response:

A. criteria B. team members C. timeline D. budget

Correct Answer: A

QUESTION NO: 4
Which of the following actions is typically NOT considered appropriate in response to an adverse event report?
Response:

A. Reviewing and updating product information to include the adverse event. B. Reporting the event to regulatory authorities within the required timeframe. C. Waiting for multiple reports of a similar event before taking any action. D. Immediate recall of all products potentially affected.

Correct Answer: C

QUESTION NO: 5
In the evaluation of atypical results, if initial investigations confirm the atypicality, the next step is to conduct a _______.
Response:

A. celebratory meeting B. staff reassignment C. cost analysis D. root cause analysis

Correct Answer: D

QUESTION NO: 6
How should a pharmaceutical company prepare for a remote evaluation?
Response:

A. By training staff on remote communication tools and digital documentation practices. B. By increasing the security around their physical facilities. C. By revising their product pricing strategy. D. By organizing a public relations campaign.

Correct Answer: A

QUESTION NO: 7
Which term means documented evidence that a system meets design requirements?

A. Commissioning B. Qualification C. Calibration D. Verification

Correct Answer: B

QUESTION NO: 8
Equipment used in packaging operations must be __________ and maintained.
Response:

A. decorated B. qualified C. outsourced D. manually operated

Correct Answer: B

QUESTION NO: 9
Which of the following statements is true about marketing requirements and compendia?
Response:

A. Marketing authorization in Europe requires compliance with the JP. B. Marketing authorization in Japan does not require compliance with any pharmacopoeia. C. The USP is the only compendium recognized worldwide. D. The EP is a requirement for marketing authorization within European countries.

Correct Answer: D

QUESTION NO: 10
Why is the analysis of data trends important in periodic product assessments like APR and PQR?
Response:

A. To plan future marketing campaigns B. To identify areas for cost reduction C. To calculate the product's market share D. To ensure continuous product improvement and compliance

Correct Answer: D

QUESTION NO: 11
In the context of APR and PQR, what is the significance of reviewing product complaints?
Response:

A. To assess the product's packaging design B. To adjust the product price C. To measure consumer brand loyalty D. To evaluate and improve product quality and safety

Correct Answer: D

QUESTION NO: 12
What is the primary goal of developing an audit schedule?
Response:

A. To determine employee vacation schedules B. To plan corporate events C. To allocate annual bonuses D. To ensure regular assessment of compliance and performance

Correct Answer: D

ASQ Certified Pharmaceutical GMP Professional - CPGP Exam Questions