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 (http://www.api-compliance.org/)
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?'
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