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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. The validation of automated or computerized systems should ensure that:
Response:

A) Systems are capable of posting updates to social media automatically
B) Systems are resistant to any form of cyber-attack, even hypothetical future threats
C) Systems require minimal to no maintenance over their operational life
D) Critical parameters are identified, controlled, and monitored

2. A stability-point failure indicates:
Response:

A) The product's success in market competition
B) The need for rebranding the product
C) A potential issue with regulatory compliance due to compromised product stability
D) An immediate need to increase production

3. An adverse event is best described as:
Response:

A) Any unexpected medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
B) A minor complaint about product packaging.
C) A feedback suggesting improvements for product design.
D) Any unsatisfactory customer service experience.

4. The re-evaluation and revalidation of unit processes should be based on:
Response:

A) Changes in product design
B) Significant process changes
C) Global economic conditions
D) New marketing strategies

5. Data archiving in computerized systems is critical for:
Response:

A) Ensuring long-term data retrieval and compliance with regulatory requirements
B) Archiving all emails and communications for entertainment purposes
C) Storing an unlimited amount of irrelevant data
D) Keeping a historical record of the company's social events

Solutions: