CPGP · Question #352
Quality unit (site) management responsibilities include: Response:
The correct answer is C. Ensuring proper batch release. Quality unit (site) management is responsible for ensuring that all products released to the market meet established quality standards - making C (Ensuring proper batch release) correct. Batch release is a core GMP (Good Manufacturing Practice) function where the quality unit…
Question
Quality unit (site) management responsibilities include:
Response:
Options
- AOrganizing team-building events
- BDesigning product packaging
- CEnsuring proper batch release
- DSetting sales targets
How the community answered
(23 responses)- A4% (1)
- B9% (2)
- C83% (19)
- D4% (1)
Explanation
Quality unit (site) management is responsible for ensuring that all products released to the market meet established quality standards - making C (Ensuring proper batch release) correct. Batch release is a core GMP (Good Manufacturing Practice) function where the quality unit reviews batch records, test results, and deviations before authorizing product distribution.
Why the distractors are wrong:
- A (Team-building events) falls under HR or management, not quality oversight functions.
- B (Designing product packaging) is a marketing or R&D responsibility, not a quality unit function (though QA reviews packaging for compliance, it doesn't design it).
- D (Setting sales targets) belongs to commercial/sales leadership - entirely outside the quality unit's remit.
Memory tip: Think of the quality unit as the "gatekeeper" - its job is to say yes or no to releasing a batch, not to plan events, create designs, or drive revenue. If a responsibility sounds like it belongs to HR, Marketing, or Sales, it's not the quality unit.
Community Discussion
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