The API Compliance Institute
The API Compliance Institute was founded on 19 December 2002. The basis for the activities of the API Compliance Institute is constituted by a contractual agreement between APIC, a sector group of CEFIC, and CONCEPT HEIDELBERG. It is the mission of the API Compliance Institute to standardise GMP audits of API manufacturers and to minimise the costs of compliance audits.
The Active Pharmaceutical Ingredients Committee (APIC) is a sector group of CEFIC. CEFIC, the European Chemical Industry Council, is both the forum and the voice of the European chemical industry. It represents, directly or indirectly, about 40,000 large, medium and small chemical companies, which employ about two million people and account for more than 30% of world chemical production.
APIC's mission is:
To represent the interests of that part of the industry engaged in the manufacture of pharmacologically active ingredients and intermediates. To be the recognised forum for the industry to address issues of relevance.
To be the recognised voice of this sector with the competent authorities.
CONCEPT HEIDELBERG was founded on 1 April 1978. Since then, its services have been focussing on the fields of pharmaceutical industry (incl. API manufacture), cosmetics industry, medical device and biotechnology. In these branches, compliance with strict quality standards is a legal requirement supervised by national and international authorities. CONCEPT HEIDELBERG offers services for putting these regulatory requirements into practice in the fields of development, manufacture and registration.
For more information about CONCEPT HEIDELBERG, please visit http://www.concept-heidelberg.de/.
APIC Audit Programme Starts in 2003!
On 19 December 2002, the APIC Auditing Programme was launched. Dr L. Hartmann from F Hoffmann-La Roche, Vice Chairman of APIC, and O. Schmidt, managing director of CONCEPT HEIDELBERG, signed an agreement of co-operation.
The APIC Audit Programme is a standardised "Third Party Auditing" model. Its aim is to offer an independent and recognised GMP compliance audit of API manufacturers and/or distributors, including organisation, conduct and evaluation of the audit. The resulting audit reports can be used by Qualified Persons of pharmaceutical enterprises within the framework of supplier qualifications. In this way, API manufacturers and pharmaceutical companies can reduce their auditing costs. At the same time, they can rely on standardised audits of high quality.
The necessary co-ordination is provided by the API Compliance Institute (www.api-compliance.org), which was founded on 1 January 2003. For further information on the APIC Auditing Programme, please contact:
Mr Pieter van der Hoeven
CEFIC Active Pharmaceutical Ingredients Committee (APIC)
Av. E. Van Nieuwenhuyse 4 / box 2
1160 Brussels, Belgium
Phone +32 2 676 72 02
Fax +32 2 676 73 01
Dr Gerhard Becker
API Compliance Institute
P.O. Box 10 17 64
69007 Heidelberg, Germany
Phone +49-(0) 6221 - 84 44 0
Fax +49-(0) 6221 - 84 44 34