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WHO, EU, PIC/S and global harmonisation of GMP - 14 Feb 2013

The current good manufacturing practices (GMP) for pharmaceutical products of the World Health Organisation (WHO) will be updated soon.  The proposed changes strongly suggest a further step towards the global harmonisation of GMP standards.  The main GMP principles of the WHO are published as Annex 3 in the WHO Technical Report Series, No. 961, 2011.  The proposed changes to chapters 1, 6 and 7 give clearer indication of the alignment to EU GMP guide.

For instance, the proposed WHO text for chapter 1 on Quality Assurance has similar expectations to the Chapter 1 of the EU-GMP guide.  When finalised, both chapters will have the same title: Pharmaceutical Quality System.  In addition, the WHO document states that the "pharmaceutical quality system (PQS) can extend to the pharmaceutical development life-cycle stage and should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities".  This is almost the same statement on PQS in the EU-GMP chapter 1.

Furthermore, the WHO revised chapter 1 emphasises senior management's responsibility with respect to Quality: "senior management has the ultimate responsibility to ensure an effective PQS is in place (…) senior management's leadership and active participation in the PQS is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the PQS." The statement on senior management responsibility is exactly the same as contained in chapter 1 of the EU-GMP.  Other comparable requirements are those on the documentation of the QM System.  For the first time, there is a requirement in both documents for a Quality Manual, describing the quality management system and the associated responsibilities.

Chapter 6 on Quality Control contains only some minor amendments.  However, the current draft for a revised chapter 6 of the EU-GMP guide provides more specifics, for instance it provides new requirements on the transfer of analytical methods as well as new regulations about the handling of out-of-specification results.

Also chapter 7 on contract production and analysis is designed to intensify the control of Contract Acceptors by the Contract Giver and to extend those controls to subcontractors.  This is in line with the new EU-GMP chapter 7 on Outsourcing Activities.

Currently, the PIC/S GMP guide mirrors the EU GMP guide. With the proposed changes to the WHO GMP guide, all regions overseen by these guides will have a harmonised GMP standard.  Although the US continues to maintain the 21CFR210 & 211, the US FDA is a member of the PIC/S further suggesting a global harmonised GMP standard.

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