Question:
Which of the following is NOT a part of GMP?
Which of the following is NOT a part of GMP?
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Good Manufacturing Practice (GMP) is the set of rules that ensures medicines are produced and controlled consistently to quality standards during manufacturing.
Updated On: Jun 24, 2026
- Personnel hygiene
- Documentation
- Clinical trial protocol
- Equipment validation
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The Correct Option is C
Solution and Explanation
Concept:
Good Manufacturing Practice (GMP) is the set of rules that ensures medicines are produced and controlled consistently to quality standards during manufacturing. It covers things like cleanliness and hygiene of staff, proper documentation, validated equipment, premises, and quality control during production.
Step 1: Go through the options. Personnel hygiene, documentation and equipment validation are all classic pillars of GMP — they all relate to how the product is manufactured.
Step 2: A clinical trial protocol, on the other hand, belongs to Good Clinical Practice (GCP). It deals with how a drug is tested on human subjects during clinical research, not with manufacturing the product. Therefore it is the odd one out and is NOT a part of GMP.
Answer: Option (3) — Clinical trial protocol is NOT a part of GMP. (3)
Good Manufacturing Practice (GMP) is the set of rules that ensures medicines are produced and controlled consistently to quality standards during manufacturing. It covers things like cleanliness and hygiene of staff, proper documentation, validated equipment, premises, and quality control during production.
Step 1: Go through the options. Personnel hygiene, documentation and equipment validation are all classic pillars of GMP — they all relate to how the product is manufactured.
Step 2: A clinical trial protocol, on the other hand, belongs to Good Clinical Practice (GCP). It deals with how a drug is tested on human subjects during clinical research, not with manufacturing the product. Therefore it is the odd one out and is NOT a part of GMP.
Answer: Option (3) — Clinical trial protocol is NOT a part of GMP. (3)
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