|
At the second GMP Conference, held in Heidelberg, Germany, at the end of June,
David Cockburn, Principal Scientific Administrator of EMEA's Inspections Sector,
presented the timetable of the European Medicines Agency (EMEA) for the near
future.
Through the Guideline ICH Q9 "Quality Risk Management", the
principles of risk management will be embedded in the regulations in Europe,
too. In detail, the plans are as follows:
- Chapter 1 of the EC GMP Guide will be amended by Quality
Risk Management.
- ICH Q9 is planned to become the - optional (!) - Annex 20.
- Within the framework of the next revision, Quality Risk
Management is also meant to be included into Part II (ICH Q7[a]) and into
the other parts of the EC Guide.
- Risk Management is planned to be integrated into the
Compilation of Community Procedures Quality. Thus, there will be more
risk-based inspections in GMP supervision.
Apart from this, Chapter 5 of the EC GMP Guide is currently
under revision. This includes:
Supplier qualification (with an indication that only APIs
manufactured in compliance with the GMP rules can be used)
"Dedicated facilities" (with a reference also to
Chapter 3 of the Guide)
Testing of raw materials (aiming at a harmonisation among
all member states)
The most interesting changes will probably be those planned for
Chapters 5.18/5.19 and 3.6 on "Dedicated Facilities".
In addition to the above revisions of the EC GMP Guide, many of
the annexes will be reviewed, too. The following changes are to be expected:
- Annex 1 (sterile products) is meant to be modified again.
Among other things, a closer connection to EN/ISO 14644 and to the FDA
Aseptic Guide is meant to be created.
- Changes to the Annex 2 (biological products) as an
adaptation due to the revision of the EC GMP Guide in Parts I and II.
Moreover, tissues are planned to be included.
- Changes in Annex 3 (radiopharmaceuticals), Annex 6
(medicinal gases) and Annex 7 (herbal medicinal products) also as an
adaptation due to the revision of the EC GMP Guide in Parts I and II.
- Update of Annex 11 (computerised systems), here, the PIC/S
document PI 011-2 will determine the basic contents.
- Changes in Annex 13 (investigational medicinal products)
regarding the storage of reference and retention samples. Clarification
concerning the division between production and QC and clarification
concerning release.
- Changes are also planned for Annex 14 (blood products) in
view of the EC Guideline 2002/98/EC.
Some of the above-mentioned documents already exist as drafts
for commenting by the public or are meant to be published by the end of this
year. A highly ambitious undertaking.
Author:
Sven Pommeranz
On behalf of the European Compliance Academy (ECA)
|
