Question:
Which guideline integrates GMP, GLP and GCP principles globally?
Which guideline integrates GMP, GLP and GCP principles globally?
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The International Council for Harmonisation (ICH) was created to bring together the regulatory authorities and pharmaceutical industry of different regions so that drug development and approval follow common, harmonised
Updated On: Jun 24, 2026
- ISO 9001
- WHO guidelines
- ICH guidelines
- Schedule M
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The Correct Option is C
Solution and Explanation
Concept:
The International Council for Harmonisation (ICH) was created to bring together the regulatory authorities and pharmaceutical industry of different regions so that drug development and approval follow common, harmonised standards worldwide. ICH provides guidelines that cover Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) under one global framework.
Step 1: Let us check the other options. ISO 9001 is a general quality management standard for any industry, not specific to pharma practices. Schedule M is an Indian regulation that deals only with GMP requirements within India. WHO guidelines provide recommendations but the question asks specifically about the body that integrates GMP, GLP and GCP globally in a harmonised way.
Step 2: ICH is exactly the international harmonisation effort that unifies these good-practice principles across regions like Europe, USA and Japan, making it the correct global integrating guideline.
Answer: Option (3) — ICH guidelines integrate GMP, GLP and GCP principles globally. (3)
The International Council for Harmonisation (ICH) was created to bring together the regulatory authorities and pharmaceutical industry of different regions so that drug development and approval follow common, harmonised standards worldwide. ICH provides guidelines that cover Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) under one global framework.
Step 1: Let us check the other options. ISO 9001 is a general quality management standard for any industry, not specific to pharma practices. Schedule M is an Indian regulation that deals only with GMP requirements within India. WHO guidelines provide recommendations but the question asks specifically about the body that integrates GMP, GLP and GCP globally in a harmonised way.
Step 2: ICH is exactly the international harmonisation effort that unifies these good-practice principles across regions like Europe, USA and Japan, making it the correct global integrating guideline.
Answer: Option (3) — ICH guidelines integrate GMP, GLP and GCP principles globally. (3)
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