In spring 2024, the new VDI expert recommendation “3rd Party GMP Audits – Supplier Audits in the Pharmaceutical Industry” was published.
The document provides a structured and professional method for evaluating and improving 3rd party audit processes. The expert recommendation method helps to increase the quality, efficiency and compliance of a company.
The benefits of 3rd party audits outweigh the risks. The implementation by external auditors enables an objective assessment of compliance with standards and regulations. However, this practice has not yet been sufficiently described in the regulations. On the initiative and with the active participation of Heacon Service GmbH, an expert committee was formed in 2022 under the umbrella of the Association of German Engineers (VDI) with representatives from the BPI, APV and the industry, among others. For the first time, the committee presented the principles for conducting 3rd party GMP audits. In the VDI expert recommendation “VDI EE 6306 3rd Party GMP Audits – Supplier Audits in the Pharmaceutical Industry” you will find information on:
– Service contract and commissioning for 3rd party audits
– Qualification of auditors
– Different types of audits (on-site, remote, hybrid, shared audits)
– Preparation, implementation and follow-up of audits
– Completion of audits
– including an appendix with further practical tips.
Our audits and quality management at pharma-audit naturally comply with all the requirements set out and thus differentiate themselves from many 3rd party GMP audits available on the market.
