APIC Revises Third-Party Auditing Programme for APIs

GMP News No. 843

GMP News
21 November 2006

APIC Revises Third-Party Auditing Programme for APIs

The Active Pharmaceutical Ingredients Committee (APIC) has revised its Third Party Auditing Programme. As announced in a current press release by the sector group of the European Chemical Industry Council (CEFIC), the revision was necessary to fully comply with the revised EU legislation, EMEA guidances and Q&A documents recently published. As a result of the changes in legislation, the Qualified Person assumes a key function for initiating a third party audit within the revised programme.

The new programme was developed after intensive review by the CEFIC/APIC quality working group and approval by the CEFIC/APIC general assembly. It was first introduced in 2002 to create independent and harmonised audit reports. The revised APIC Auditing Programme will minimize the costs e.g. by offering shared third-party audits on behalf of more than one QP. The audits are conducted on the basis of the ICH Q7A (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and with regards to the APIC Auditing Guide. Participation is voluntary and not limited to APIC members.

The programme is implemented by the "API Compliance Institute" which was also founded in 2002.

The complete release can be found on the Institute's website at www.api-compliance.org.

Get to know the requirements of ICH Q7A in detail and step by step – in the ECA "ICH Q7A Training Courses", 5-9 February 2007 in Prague, Czech Republic.

Choose between the two 3-day GMP education courses – ICH Q7A Compliance for APIs Manufactured by Chemical Synthesis or ICH Q7A Compliance for APIs Manufactured by Cell Culture/ Fermentation – and take advantage of combining them with the ICH Q7A Auditor Training Course.

Prepared by:
Wolfgang Heimes
On behalf of ECA

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