The EMEA published its „Work Plan for Ad hoc
GMP Inspection Services 2006". In this plan the EMEA documents the
planned and already started activities in the GMP environment. Part of
these activities are:
- 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
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