Shared Audits: How Can You Find Partners in Order to Share Audit Costs?

'Shared audits' are on everyone's lips. The term describes the fact that several firms hold a joint audit of the same supplier. Such a procedure can reduce the costs considerably. Above all pharmaceutical enterprises with a large number of suppliers face a genuine challenge. Here, the costs resulting from the large number of audits are not the only problem.

Some API (active pharmaceutical ingredients) manufacturers have no free capacities due to the large number of enquiries. Now, the pharmaceutical enterprise is in a difficult situation. On the one hand, the audit must be performed in order to be able to furnish the corresponding proof within the framework of the GMP inspection, on the other hand, the enterprise does not get an appointment for performing the audit, since the API manufacturer is already being audited by other companies. Thus, shared audits can reduce the investment of time and money both on the part of the pharmaceutical company and on the part of the API manufacturer. Often, the sheer number of required audits poses a problem. Not every pharmaceutical company can conduct all audits itself and with its own resources. Admittedly, there is the possibility to charge external consultants/service providers with this task. However, in case of a major number of audits, this is certainly not the most budget-friendly solution. Apart from this, the pharmaceutical enterprise has to make sure (e.g. by means of a contractual agreement) that the consultant has not worked for the supplier to be audited, since this situation would confront him with a conflict of interests. Such a conflict of interest renders an audit, and thus the audit report, useless.

The European QP Association has now developed a system enabling QPs to find out quickly and informally if other firms are also interested in a certain API or excipient manufacturer. By this time, the organisation has 1,300 members. Each member has access to a database in which one can see within seconds if and - if so - how many QPs are interested in an audit of a certain supplier. Furthermore, each member can enter further potential suppliers into the database. In this way, the database grows virtually on a daily basis through the organisation's members. The QP Association is not involved itself in the performance of the audits. The organisation merely offers a procedure for establishing the first contact between the firms or the QPs. Then it is up to the QPs involved if e.g. one of the pharmaceutical companies conducts the audit and shares the costs with the others or if a third party is charged with the task.

Very few programmes available on the market fulfil EMA's (formally known as EMEA) requirements. The EMA requirements on third-party audits can be found here). For APIs, there is currently the APIC Third Party Audit Programme. For excipients, the IPEC/EFCG Audit Programme (EXCIPACT) is soon to be introduced.

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