Question:medium

Manufacturing Specification for tooling has been standardized by?

Show Hint

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} $
Show Solution

The Correct Option is C

Solution and Explanation

Step 1: Understanding the Question.
We need to identify which body standardizes manufacturing specifications for tooling, the punches and dies used in tablet compression.

Step 2: Key Approach.
Separate bodies that regulate drug approval and quality policy from the one body that actually publishes physical tooling dimensions for tablet manufacture.

Step 3: Detailed Explanation.
USFDA and CDSCO both work at the level of drug approval, licensing and compliance, not equipment dimensions. WHO sets broad international quality guidance rather than manufacturing-level detail. The Indian Pharmacopoeial Commission, alongside publishing the Indian Pharmacopoeia, standardizes punch and die tooling specifications, which keeps tooling from different makers interchangeable on compression machines.

Step 4: Final Answer.
Manufacturing specification for tooling has been standardized by the Indian Pharmacopoeial Commission.
Was this answer helpful?
2