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The APIC Audit Programme - Objective

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What Is 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.

Click for a larger version

The participation in the "APIC Audit Programme" is on voluntary basis and not limited to members of APIC.
 

How Can GMP Audits Be Standardised?
 

There are three basic principles of the "APIC Audit Programme" for standardizing audits:

  • experienced and trained auditors that are registered as APIC certified auditors
  • standardised process for preparing audits
  • release of audit report by experienced API specialists
The audits are conducted by APIC certified auditors
  • who have the professional experience,
  • who have completed an ICH Q7a compliance education course including an examination and a special APIC Auditor Training
  • who have participated in recognised training courses/conferences on current GMP topics
  • who have signed a contract laying down the obligations as an auditor in the framework of the APIC Audit Programme

The audits are conducted on the basis of the EC GMP Guide Part II/ICH Q7A (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) with regard to the APIC Auditing Guide.

 

Save Money and Optimise the GMP Audit

 

The aims of The "APIC Audit Programme" are:

  • standardised GMP audits of API manufacturers
  • minimised costs by
    • decreasing the frequency of audits when making the audit report available to pharmaceutical companies
    • standardized costs for audits
 

Will Third-Party Audits Be Accepted by the Authorities?

 

An audit is an important tool for evaluating GMP compliance.

A frequently asked question in connection with the APIC Audit Programme is whether a third Party audit will be accepted by the authorities.

According to the draft Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Active Substances used as starting materials' 'it is expected that the holder of the manufacturing authorization 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.'

This clearly states that third party audits are being accepted.

Similar third party programmes have already been established in other areas: ARC (Audit Repository Center), a PDA-associated company, offers auditing programmes for the audit of software suppliers, the IPEC (International Pharmaceutical Excipients Council) provides Third Party Auditing Programmes for excipient suppliers. With regard to the acceptance of Third Party Audits IPEC member Irwin Silverstein said "lawyer with both industry and FDA experience have been involved in developing the program and (that) nobody has raised a concern that the third party audit would present more of a problem than having your own people do the same audit". (Gold Sheet, Vol 34, No. 1, January 2000).

*) A declaration from the manufacturing authorization holder that the active substance(s) concerned has(have) been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting material.

 

Who Coordinates the APIC Audit Programme?

 

The APIC Audit Programme will be coordinated by 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 the API Compliance Institute. It is the mission of the API Compliance Institute to standardize GMP audits of API manufacturers and to minimize the costs.

For further information about the APIC Audit Programme, please download this brochure in PDF format.

 

Experience Report

 

Genzyme Pharmaceuticals was among the first companies who participated in the APIC Audit Programme. The experience report can be found here.