EMEA plans the revision of various GMP requirements

• Inspections under the Centralised System
• Mutual Recognition Agreements for GMP Inspections
• Harmonisation Efforts
• Current GMP Initiatives (new and revised GMP requirements)

The EMEA wants to ensure that manufacturing sites outside the EU are re-inspected regularly to determine that these sites fulfil the same requirements as sites inside the EU. The organisation also plans to expand the already existing GMP database with the manufacturers inside and outside of the EU.

Relative to harmonisation the EMEA plans to review the so-called „Compilation of Procedures". Foremost this means to define a process for withdrawing a Certificate of Suitability (CEP) when major violations against GMP requirements are identified during inspections of API manufacturers. In this regard the EMEA also plans to align inspection regulations for API manufacturers with PIC/S. Further, the organisation currently examines how requirements derived from ICH Q9 "Quality Risk Management" can be implemented in GMP guidelines and in GMP inspections. Currently Risk Management is implemented in chapters 3 and 5 of the EG GMP guideline – relative to the question when "dedicated facilities" are required.

As before the GMP requirements will most likely be fundamentally changed in 2006 again. Due to the agreed restructuring of the GMP guideline in 2005 several Annexes will have to be revised. As a result of the new structure the Annex 18 "GMP for the manufacture of APIs" is not an Annex any longer but rather builds part 2 of the EU GMP guideline – side by side with the GMP requirements for the manufacture of medicinal products. Thus all Annexes of the EU GMP guideline are now also valid for API manufacturers. For that reason the EMEA plans to revise the following Annexes:

• Annex 2 (Biologic Substances)
• Annex 3 (Radiopharmaceuticals)
• Annex 6 (Medicinal Gases)
• Annex 7 (Herbal Medicinal Products)

The new guideline structure will lead to an amendment of chapter 5, part 1, defining the requirements for the qualification of suppliers.

In addition the EMEA plans to complete the revision of Annex 1, dealing with sterile production, and to revise or amend the Annexes 14 (Blood Products) and 16 (Qualified Person and Batch Release).

Like in the years before the EMEA plans essential changes of the EU GMP guideline for 2006. That means that both the EMEA and the FDA prepare GMP requirements adaptations, first to take into account new developments (new technology, PAT) and second to emphasise risk management aspects as part of the evaluation.

Author:
Oliver Schmidt
On behalf of the European Compliance Academy

Source: EMEA Website: http://www.emea.eu.int/Inspections/docs/GMPwp2006.pdf