The PDA Audit Guidance Advisory Board (AGAB) provides governance and oversight to the Audit Resource Center (ARC) as well as maintains the supplier audit process; as published in PDA Technical Report No. 32 “Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations” (Revised 2004).

Additionally, the Board identifies global auditing issues of interest to PDA membership. Once an issue is identified, the Board forms a Task Force to study and to prepare written comments or documents such as Technical Reports or consensus responses to regulatory draft and final guidance and directives.

The AGAB is composed of individuals who have demonstrated history and technical excellence within the scope of PDA activities. Currently, there are 12 members of the board drawn from industry, consultants and suppliers. The Board has a chair and a co-chair, who are approved by the PDA Board of Directors.

The current Task Force is the Standard Audit Criteria Task Force that is charged to develop and implement a Standard set of Audit Criteria intended for the Pharmaceutical and Medical Device industry for use in a variety of supplier audits.

A future Task Force to be formed in early 2010 is the TR-32 Revision Task Force.

For more information about the PDA Audit Guidance Advisory Board or the task forces, contact Iris Rice (rice@PDA.org), Executive Coordinator, Scientific and Regulatory Affairs Department at PDA.