. ICH Q7 WEEK .
About 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 "APIC Audit Programme"
The "APIC Audit Programme" is a third party audit programme for auditing API manufacturers, distributors and API contract manufacturers and/or contract laboratories.
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.
An 'APIC Audit' within the framework of the APIC Audit Programme can be initiated by one or more QPs of one or different manufacturing authorisation holders in order to get independent information about the GMP compliance status about the API supplier, e.g. when preparing for authority inspections. It can also be initiated by an API manufacturer himself.
The following chart describes three scenarios where a Third Party Audit can be initiated and shows the corresponding costs.