Internal Audits of the Information Officer - Dispensable or Added Value?

In the pharmaceutical industry, particularlly in the GMP and GDP area, internal audits are a fundamental and indispensable part of quality management. However, the activities and processes involving the Information Officer (IO) in accordance with Section 74a of the Medicinal Products Act are rarely independently audited, even though this role is governed by strict legal regulations and personal accountability.

Perhaps the supposedly clear legal regulation of responsibilities leads to inactivity. Or companies may refrain from taking regular quality assurance measures due to the infrequent official IM inspections in Germany. We can only speculate about the reasons. Nevertheless, essential, business-relevant processes should be integrated into an effective quality management system, as the responsibility of the IM potentially harbors considerable financial and possibly also legal risks, be it through recalls of obsolete materials or attacks by competitors.

A recent IO audit conducted by Saidia at a client’s site highlighted the importance of such evaluations. The audit critically assessed existing processes and provided valuable recommendations for optimization, which are now being incorporated into SOPs and business processes. Key focus areas included the efficient use of digitalized material approval processes and improved structured collaboration within cross-functional teams. Moreover, the audit the crucial role of a competent IO, who should proactively see his/ her work as a driver of quality, thus adding significant value to the pharmaceutical company.

A detailed analysis of advertising materials during the audit not only reinforced the robustness of marketing claims but also minimized potential risks, such as future disputes with competitors. Ensuring compliance with product claims generally enhances marketing efforts. The creative pressure that arises from maintaining compliance often inspires innovative solutions, providing a competitive edge and driving product success.

Therefore, it is essential to implement a quality management system that includes regular internal IO audits. In the end, every pharmaceutical company benefits from a comprehensive and well-developed quality management system - even if the benefits are not immediately apparent.