WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Close this folder6. Quality assurance - good manufacturing practices
View the document6.1 Specific GMP guidelines for radiopharmaceutical products
View the document6.2 GMP guidelines for active pharmaceutical ingredients
View the document6.3 WHO GMP: main principles for pharmaceutical products
View the document6.4 WHO basic training modules on GMP
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

6.2 GMP guidelines for active pharmaceutical ingredients

The Committee was informed of the background to the development of the ICH GMP guidelines for active pharmaceutical ingredients (APIs), including the earlier involvement of the Pharmaceutical Inspection Cooperation Scheme in initiating the preparation of this guide.

The Committee recognized the difficulty that countries would have in implementing the ICH GMP guide in a short period of time. The Committee was informed that, from a legal standpoint, WHO cannot simply take over any GMP document from another source. The Committee therefore considered that it would be best for the current WHO GMP for APIs to be revised to reflect current GMP requirements.

The Committee agreed that WHO should review the current WHO GMP for APIs, taking into account other published guidelines, including the ICH document, and also consider current practices. The Committee endorsed the step-wise approach to the implementation of GMP for APIs.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: November 5, 2014