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WHO revises GMP Guide - 14 Aug 2013

The WHO GMP guide was initially published in the late 1960’s and has since undergone several revisions since then as expected.  The current version published in 2011 as Annex 3 of the Technical Report Series (TRS) 961 was revised in late 2012.  It has now been re-circulated as a new draft of working document for comments after discussion and approval of subgroup with expert inspectors.

The main changes addressed in this document affect the following sections;

1. Pharmaceutical Quality System (formerly Quality Assurance)

By replacing the Quality Assurance with Pharmaceutical Quality System (PQS) similar to changes in ICH Q10, the involvement of senior management within the quality system is now explicitly required.  Furthermore, the term CAPA has been added therefore requiring deviations to be investigated and preventive measures implemented and monitored for effectiveness.

2. Good Manufacturing Practices for pharmaceutical products

In Chapter 2, the GMP was previously described as a means to reduce risks in pharmaceutical production. However with the revision, the expectation is that in addition to minimising the risks, these should also be managed.  Also, the term GDP (Good Distribution Practice) makes its debut in the WHO GMP guide.

3. Contract Production & Analysis

Chapter 7 of the GMP guide addressing Contract Production & Analysis has also been revised.  The main change is the requirement for the contract giver to audit the premises of contract acceptors and sub-contractors.

4. Good Practices in Quality Control

Only minor editorial changes are presented in section 17 dealing with Quality Control.  The principle & fundamental requirements for an independent QC from production is given more clarity with the editorial changes.

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