5th Conference in 2002

11 December 2002

5th European API Conference – Review

From 13 - 15 November 2002, the 5th CEFIC/APIC European Conference on Active Pharmaceutical Ingredients took place in Barcelona. More than 210 participants and speakers from FDA, EMEA, EDQM, BfArM, AFSSAP as well as from various API manufacturers discussed topical questions regarding ICH Q7A GMP compliance and new regulatory requirements.

During the presentation of Dr Chiu Emer Cooke from EMEA informed about the coordination of the GMP inspections through EMEA. She is Head of Inspections and in this function responsible for GMP, GLP and GCP inspections. She gave a report on the current GMP inspection activities since 1999.

Current Coordination
Centralised Statistics since 1999

  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

  1. 7 Materials Management (29%)
  2. 17.2 Traceability of Distributed APIs (19%)
  3. 2 Quality Management (14%)
  4. 15 Complaints and Recalls (14%)
  5. 3 Personnel (12%)
  6. 10 Storage and Distribution (10%)
  7. 4 Building and Facilities (6%)

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:

  1. Revision of FDA Drug Substance Guideline of 1987
  2. Risk-based CMC Review update
  3. 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.

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