History

The expediency of joint audits in view of qualitative and economic aspects has already been common knowledge for many years. In 1998, a working group of Quality Control managers from distinguished pharmaceutical companies developed a first approach for auditing excipient manufacturers applying the principle "Two for all". In 2000, a project was started under the umbrella of the vfa (research based pharmaceutical companies) - "Joint Audit Procedure for Excipient manufacturers". The date of its foundation was Nov 15th, 2000. Founders were member companies of the vfa and the working group of Quality Control managers, respectively. After signing an agreement which defined the basic principles and after the implementation of an administrative body, the first joint audits were performed in 2001.

Since the beginning the following principles were applied:
  • The responsibility for the acknowledgement of audits remains with every individual member company;
  • The administration overhead was to be reduced to an absolutely essential minimum;
  • A maximum of autonomy for each member company should be maintained;
  • Implementation of common standards was to be restricted to the absolutely necessary minimum.


These values are still upheld today and continue to be the guarantee for our success.

The joint audit concept was later on extended to some manufacturers of generic APIs, to manufacturers of packaging materials and logistics services.

Nowadays, every year about 40 joint Audits are performed resulting in more than 500 audit documentations in our archives (mid 2015). On average, the ratio of member companies participating in a joint audit to members requesting audit documentations is one to five.