| |
1999 |
2000 |
2001 |
2002 |
| Active Substances |
3 |
16 |
21 |
11 |
| Total |
21 |
48 |
59 |
52 |
| % |
14 |
25 |
35 |
22 |
One of her subjects was the current proposal for the new legislation.
She emphasised that it recommends that GMP inspections of API
manufacturers should be conducted on the basis of Annex 18 (ICH Q7A).
According to the proposal, it is also planned that EMEA should manage a
register of the results of these inspections (Certification of GMP and of
Non-GMP Compliance).
As to the time frame for the implementation of the new legislation, Mrs
Cooke stated that it would probably not be realised
before 2005. The reason for this delay was to be found in the
comprehensive revision of the European pharmaceutical legislation that is
currently being made.
Afterwards, Dr Lothar Hartmann from Hoffmann-La Roche presented the new
APIC Audit Programme. This programme enables API manufacturers to have a
standardised GMP audit conducted by qualified auditors. It is the aim of
the programme to reduce costs of audits on the one hand and to create
an opportunity to have an independent GMP compliance assessment on the other hand.
(Via this
link you can download a brochure with details about the APIC Audit
Programme.)
Olivier Gross of the French supervisory authority informed about
his experiences with inspections of traders and brokers. During the
hitherto conducted inspections, the following major deviations had been
found:
Deficiencies observed according to the ICH Guide
The third day was dedicated to new regulatory requirements. Dr Bachmann
of the German Federal Institute for Drugs and Medical Devices (BfArM)
informed about the planned revision of the Variations Regulation, which
had been published not long ago. As next steps he listed:
-
New Variation Application Form (one for all types) – to be discussed
at NtA
-
Proposal for a harmonised numbering system for mutual recognition and
centralised variations – adopted by the MRFG/EMEA – to be discussed at
NtA
-
New 'MRFG Best Practice Guides' for Variations – to be discussed at
MRFG
Subsequently, FDA's Dr Chiu dealt with 3 current developments
within FDA:
-
Revision of FDA Drug Substance Guideline of 1987
-
Risk-based CMC Review update
-
FDA GMP Initiative
She stressed the fact that FDA's new risk-based approach plays a
central role both in the CMC Review and in the GMP Initiative. FDA intends
to use its resources according to the health risk; this is true of GMP
inspections as well as of the CMC Review. In her summary, Dr Chiu itemised
among other things the revision of 21 CFR Part 210/211 as well as the
reassessment of the requirements on electronic records and signatures
(Part 11) as activities of the new GMP Initiative.
Corinne Pouget from EDQM gave an experience report on the inspections
coordinated by EDQM (inspections of API sites holding CEPs). During the
pilot phase from October 1999 to March 2000, 5 API sites in
5 countries were inspected. In the second phase, beginning in April
2001, sites that are located in other countries, e.g. in Eastern Europe,
China and India, and that produce various substances (excipients, TSE risk
products, sterile APIs) were inspected. For 2003, about 2 inspections
per month are planned.
The 6th European API Conference, which will take place in
autumn 2003, is in preparation. If you are interested in attending it,
please send an e-mail to info@gmp-compliance.org We will inform you as
soon as the programme is ready.
In case you are interested in becoming an APIC member, send an e-mail
to pvd@cefic.be or visit the website http://apic.cefic.org/
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
