5th European API Conference - Review

GMP News No. 269

GMP News
11 December 2002

5th European API Conference – Review

From 13 - 15 November 2002, the 5th CEFIC/APIC European Conference onActive Pharmaceutical Ingredients took place in Barcelona. More than210 participants and speakers from FDA, EMEA, EDQM, BfArM, AFSSAP aswell as from various API manufacturers discussed topical questionsregarding ICH Q7A GMP compliance and new regulatory requirements.

During the presentation of Dr Chiu

Emer Cooke from EMEA informed about the coordination of the GMPinspections through EMEA. She is Head of Inspections and in this functionresponsible for GMP, GLP and GCP inspections. She gave a report on thecurrent GMP inspection activities since 1999.

Current Coordination
Centralised Statistics since 1999

Active Substances3162111

One of her subjects was the current proposal for the new legislation.She emphasised that it recommends that GMP inspections of APImanufacturers should be conducted on the basis of Annex 18 (ICH Q7A).According to the proposal, it is also planned that EMEA should manage aregister of the results of these inspections (Certification of GMP and ofNon-GMP Compliance).

As to the time frame for the implementation of the new legislation, MrsCooke stated that it would probably not be realisedbefore 2005. The reason for this delay was to be found in thecomprehensive revision of the European pharmaceutical legislation that iscurrently being made.

Afterwards, Dr Lothar Hartmann from Hoffmann-La Roche presented the newAPIC Audit Programme. This programme enables API manufacturers to have astandardised GMP audit conducted by qualified auditors. It is the aim ofthe programme to reduce costs of audits on the one hand and to createan opportunity to have an independent GMP compliance assessment on the other hand.

Olivier Gross of the French supervisory authority informed abouthis experiences with inspections of traders and brokers. During thehitherto conducted inspections, the following major deviations had beenfound:

Deficiencies observed according to the ICH Guide

The third day was dedicated to new regulatory requirements. Dr Bachmannof the German Federal Institute for Drugs and Medical Devices (BfArM)informed about the planned revision of the Variations Regulation, whichhad been published not long ago. As next steps he listed:

  • New Variation Application Form (one for all types) – to be discussedat NtA
  • Proposal for a harmonised numbering system for mutual recognition andcentralised variations – adopted by the MRFG/EMEA – to be discussed atNtA
  • New 'MRFG Best Practice Guides' for Variations – to be discussed atMRFG

Subsequently, FDA's Dr Chiu dealt with 3 current developmentswithin 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 acentral role both in the CMC Review and in the GMP Initiative. FDA intendsto use its resources according to the health risk; this is true of GMPinspections as well as of the CMC Review. In her summary, Dr Chiu itemisedamong other things the revision of 21 CFR Part 210/211 as well as thereassessment 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 inspectionscoordinated by EDQM (inspections of API sites holding CEPs). During thepilot phase from October 1999 to March 2000, 5 API sites in5 countries were inspected. In the second phase, beginning in April2001, sites that are located in other countries, e.g. in Eastern Europe,China and India, and that produce various substances (excipients, TSE riskproducts, sterile APIs) were inspected. For 2003, about 2 inspectionsper month are planned.

The 6th European API Conference, which will take place inautumn 2003, is in preparation. If you are interested in attending it,please send an e-mail to info (at) gmp-compliance (dot) org We will inform you assoon as the programme is ready.

In case you are interested in becoming an APIC member, send an e-mailto pvd@cefic.be or visit the website http://apic.cefic.org/

Oliver Schmidt



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