Third Party Audit as a Part of Shared Audits

GMP News Nr. 98

GMP News
March 1, 2001

 

Third Party Audit as a Part of Shared Audits

A model for the auditing of suppliers of computer hard- and software in the USA; news from the Audit Repository Center

While the performance and acceptance of third party audits as part of the supplier qualification in the purchasing of pharmaceutical starting materials is still the subject of controversial discussion, in the USA progress is already being made with respect to shared audits of computer hard- and software suppliers.

With the aim of reducing the time input caused by supplier audits and the related costs for the pharmaceutical company and the supplier themselves PDA has developed an extensive audit program. A basic concept of this audit program is the forwarding within the framework of an audit of information which appears to pharmaceutical companies without having to reveal confiderntial information about the supplier. For this purpose PDA has founded a separate company, ARC (Audit Repository Center) which, on the one hand, organizes the performance of audits and, on the other hand, manages and exchanges between the pharmaceutical companies the data occurring during audits while respecting confidential supplier-related information (see web page http://www.auditcenter.com).  The auditors are selected by ARC from a pool of qualified and independent auditors, whereby PDA itself qualifies the auditors.

Details on the PDA audit program are published in the PDA Technical Report #32 “Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations”  and can be obtained from PDA on CD-ROM (http.//www.pda.org).

Pharmaceutical companies have various options for taking part in ARC audit programs:

  • the pharmaceutical company conducts the audit themselves and submits the audit information to ARC

  • the pharmaceutical company has the audit carried out by an auditor from the ARC auditor pool as a third party audit and the information is submitted to ARC

  • the pharmaceutical company obtains audit information from the ARC data archive.

The suppliers, i.e. the computer hard- and software companies can for their part commission an audit according to the ARC audit program. The audit will in this case be conducted by an auditor appointed by ARC, the audit information managed by ARC and it can be forwarded to interested pharmaceutical companies.

To date a total of 6 computer companies have been audited within the framework of this PDA model, including QUMAS Ltd., a supplier of Electronic Records Document Management Systems and Applied Biosystems, a supplier of Laboratory Information Management Systems including the QA Stability & Schedule Modules.

It remains to be hoped that this PDA audit model will be a trailblazer for the acceptance of shared audit models also within the framework of supplier qualification in the purchasing of pharmaceutical starting materials.

 

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