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.
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