The current good manufacturing practices (GMP) for pharmaceutical products of the World Health Organisation (WHO) are going to be updated. WHO's GMP main principles are published as Annex 3 in the WHO Technical Report Series, No. 961, from 2011.
When looking at the proposed changes, it seems that the changes reflect another step towards harmonisation in global GMP standards. Especially the proposed WHO text for chapter 1 on Quality Assurance defines comparable expectations to the new chapter 1 of the EU-GMP Guideline. Both are now having the same title: Pharmaceutical Quality System. The current title of the WHO document is "Quality Assurance". The new document now 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 exactly the same statement which can be found in the EU-GMP chapter 1.
Also the emphasis of the senior management's responsibility has been pointed out: "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 organization to the PQS." These can be found in exactly the same words in EU-GMP chapter 1.
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.
Also chapter 7 on contract production and analysis is obviously 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.
Chapter 6 on Quality Control contains only some minor amendments. Here the current draft for a revised chapter 6 of the EU-GMP Guide seems to be a little more precise, providing new requirements on the transfer of analytical methods as well as new regulations about the handling of out-of-specification results.
ECA members can download the WHO Working document QAS/13.517 and the form for comments in the members' area of the ECA website.