Question:
Manufacturing Specification for tooling has been standardized by?
Manufacturing Specification for tooling has been standardized by?
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IPC not only sets monographs but also standardizes equipment specs like punches, dies, and tooling in tablet manufacturing.
Updated On: Jul 14, 2026
- $ \text{USFDA} $
- $ \text{CDSCO} $
- $ \text{Indian Pharmacopoeial Commission} $
- $ \text{WHO} $
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The Correct Option is C
Approach Solution - 1
- The Indian Pharmacopoeial Commission (IPC) is the official body responsible for setting standards of drugs in India under the Ministry of Health and Family Welfare.
- It also standardizes manufacturing specifications for tooling — particularly the punches and dies used in tablet compression.
- This ensures interchangeability, efficiency, and quality control across different tablet manufacturing lines.
- It also standardizes manufacturing specifications for tooling — particularly the punches and dies used in tablet compression.
- This ensures interchangeability, efficiency, and quality control across different tablet manufacturing lines.
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Approach Solution -2
The question asks which body has standardized manufacturing specifications for tooling, meaning the punches and dies used in tablet compression. Let's check each body against this specific role.
- USFDA: The US Food and Drug Administration regulates drug approval and manufacturing practice in the United States, but it does not publish the dimensional tooling specifications Indian tablet manufacturers work to.
- CDSCO: The Central Drugs Standard Control Organisation is India's national drug regulatory authority, responsible for approvals, licensing and enforcement, not for fixing the physical tooling dimensions used on compression machines.
- Indian Pharmacopoeial Commission: The IPC is the body that publishes the Indian Pharmacopoeia and, alongside it, the standardized tooling specifications for punches and dies, covering dimensions, cup depth and related parameters. This standardization lets tooling from different manufacturers stay interchangeable across compression machines, which is exactly the role the question describes.
- WHO: The World Health Organization sets broad international health and quality guidelines, but tablet tooling specification is a manufacturing detail handled at the national pharmacopoeial level, not by WHO.
Only the Indian Pharmacopoeial Commission is tasked with fixing tooling dimensions as part of its pharmacopoeial standard-setting role, the other three bodies work at the level of drug approval and broader quality policy instead.
Therefore, the correct answer is Indian Pharmacopoeial Commission.
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