These resource requirements are based on a standard auditing methodology that involves the assessment of the service providers compliance to international and local regulations and guidance, standard operating procedures (SOPs), and contracts; reviewing/verifying data and evaluating control documentation; interviewing key personnel; presenting observations according to a root cause approach; and following up after receipt of a corrective action plan and audit closure.

Table 2. The type of time commitment service providers can expect to make when they host an audit.

It is the intent of the inter company audit collaboration initiative described here to avoid such duplication of efforts and achieve greater efficiencies for both pharma and service providers in the quality management oversight of routinely used and cyclically audited service providers.

The basic concept of this initiative is the pre-agreed (with service provider) sharing of objective and nonproprietary data in audit reports between clearly identified sponsor companies. These reports are used as one component of each sponsor company's risk management strategy related to their service providers. Each company draws its own conclusions from the report in the context of the scope of the audit performed and their specific needs at the time. The auditing company does not make recommendations to the other sponsor companies receiving the report—an important facet of the program with regard to anti-trust legislation. The initiative is not:

• one of performing joint audits or
• one of performing audits on behalf of another company or partnership.

Nor is it for any collusive discussion to exert commercial leverage. Rather, it is an initiative for the simple sharing of objective information in audit reports. The detailed concept is made clear in the Cooperation Agreement signed between the sponsor companies taking part and in the agreement letter signed by service providers prior to the sharing of the audit reports. Principles embedded in the Cooperation Agreement include mutual recognition of auditor capability, audit conduct, and audit reporting of the different parties; protection of proprietary information; controlling the use and distribution of information obtained during pre-agreed and approved processes; respect for existing confidentiality agreements, especially no sharing of information on commercial matters.

Tools and tactics

Table 3. Standardization plays an important role in successfully managing the collaboration process.

Participating sponsor companies meet at regular quarterly face-to-face meetings and hold monthly teleconferences to share and align selected QA programs related to service providers of mutual interest. Minutes are kept and archived. No participating sponsor company will perform an audit that was not already on their own audit plan. Agreeing upon which company will conduct a particular audit will depend on when each company had intended to conduct it, the particular audit scope, and the priority of the audit for the individual members.

The overriding principle is to maximize the efficient use of the participating sponsor companies' resources in performing quality audits of service providers normally audited in a routine cyclical fashion by group members. The aim is to avoid the duplication of time and effort required by these service providers in facilitating multiple audits of similar scope.