Third-Party GMP Audits of API Manufacturers - EMEA Gives Green Light

GMP News No. 652

GMP News
16 December 2005

Third-Party GMP Audits of API Manufacturers - EMEA Gives Green Light

Directives 2001/83/EC and 2001/82/EC as amended oblige manufacturing authorisation holders (for medicinal products for human and veterinary use) to use as starting materials only active substances that have been manufactured in accordance with the GMP guidelines for APIs.

Furthermore, the applicant for a marketing authorisation will be required to include a declaration from the manufacturing authorisation holder that the active substance(s) concerned has/have been manufactured in accordance. (…) It is expected that the holder of the manufacturing authorisation will base such a declaration on carrying out, or having carried out on his behalf, an audit of the manufacturers/distributors of the active substances concerned.' (see 1).

Audits are one of the major tools of supplier qualification, but there have still been a lot of questions regarding audits of API manufacturers, e.g. the acceptance of third parties performing these API GMP compliance audits.

The EMEA GMP Inspections group took this problem 'on board' and recently published a Q&A paper referring to audits of active substance manufacturers (2).

The question '(…) Is an audit performed by a third party acceptable?' is answered with a clear yes, provided there is no conflict of interest:

'(…) that the results of an audit carried by the third party are credible thus waiving the need for an audit conducted by the manufacturing authorisation holder itself. However, it must also be satisfactorily demonstrated that there is no conflict of interest. Conflicts of interest could arise for example from:

•  A commercial relationship between the organisation performing the audit and the organisation being audited.

•  A personal conflict on the part of the auditor where he/she has been employed by the organisation being audited in the recent past (i.e. within the last 3 years) or has a financial interest in it. (…)' (see (2), Q1/A1).

This clear authority's statement gives green light for the "APIC Audit Programme" , a standardized third party audit programme for auditing API manufacturers, distributors and API contract manufacturers and/or contract laboratories.

This programme was developed by APIC/CEFIC in co-operation with CONCEPT HEIDELBERG. It is the aim of the APIC Audit Programme to offer an independent and 'turnkey' GMP Compliance audit of API manufacturers and/or distributors, including organization, conduct and evaluation of the audit.

The APIC Audit Programme will be coordinated by the API Compliance Institute.

For further information about the APIC Audit Programme, please visit the web page of the API Compliance Institute (

EMEA's agreement on third parties is a first step to relief API- and pharmaceutical companies from the audit burden. Nevertheless there remain still some questions unanswered, e.g. 'Is a third party audit being accepted when initiated by the API manufacturer?'

If you are interested to become an APIC certified ICH Q7a auditor and conduct API GMP audits in the framework of the APIC Audit Programme, please look at the programme of the courses 'Certified ICH Q7A Auditor Training Course' that will be held from 01-03 February 2006 in Barcelona/Spain or contact us directly (



  • see Draft Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Manufacturers of Active Substances used as starting materials;
    Please click here.
  • see EMEA website, 'Inspections', Good Manufacturing Practice: Questions & Answers on audits of active substances manufacturers
    Please click here.
  • Author:
    Dr Barbara Jentges
    on behalf of ECA


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