Finished Medicinal Product Audits

As the name already says, finished medicinal products are not mere active substances or intermediates, but fully completed products ready for dispensing to the consumer.

Manufacturers of finished medicinal products are subject to strict certification requirements and must ensure that the manufacturing, packaging, labelling, storage, transport and control of both the finished medicinal products and their starting materials used comply with the standards of Good Manufacturing Practice (GMP).

Regardless of whether the manufacturers produce solid, liquid, semi-solid, sterile or non-sterile finished medicinal products, our audits at your finished medicinal product manufacturers verify the conformity of the entire system with the corresponding GMP guidelines. This includes, for example, the EU-GMP Part I guidelines with all associated annexes for the European market. Our aim is to help you provide high-quality and safe products for your customers.

Our tailored audits for finished medicinal products enable us to shed light on individual aspects of your business. We produce detailed and high-quality reports for you. Our experienced experts are guided by your questions and priorities that are to be addressed during an audit.

Finished medicinal product audit worldwide

Our worldwide available team of qualified and experienced auditors adapts flexibly to your requirements and guarantees straightforward and efficient handling. Our experts in the audit field are familiar with the common guidelines and conduct audits for various markets, be it in Europe, the USA, Japan or China.

For each audit at finished medicinal product manufacturers, we provide you with a team of at least one experienced lead auditor with the appropriate expertise. Our proven standard process provides that both a lead auditor and a co-auditor are scheduled for each audit. All our auditors go through a strict qualification process including a witness audit.

Special focus: sterile manufacturing

Naturally, there are also manufacturing areas that must withstand special requirements. These include products derived from human blood or plasma (Annex 14), radiopharmaceuticals (Annex 3) and, above all, all sterile manufacturers (Annex 1). In these cases, the auditors are selected with special attention to experience and knowledge in the relevant areas. In this way we ensure that, in the example of sterile products, the topics of staff qualification, media fill and microbiological analyses are considered in a particularly qualified manner.

If you find an audit report in our database that does not exactly match your finished medicinal product, no worries! We carry out a supplementary audit (remote or on site) at this manufacturer for you. The result is a complete, individual and detailed finished medicinal product audit report that helps you ensure the quality and safety of your product and to pass regulatory inspections with confidence.