The principles of Good Manufacturing Practice (GMP) govern the manufacture of medicinal products. It is critical that medicinal products are suitable for their intended purpose, comply with the approval documents, and that no patient is endangered by a lack of safety, quality or effectiveness of a medicinal product.
Any contract manufacturers, contract laboratories and warehouses as well as traders (supply chain) involved in production must also be monitored for GMP compliance.
A particular challenge in light of the complexity of the increasingly fragmented drug manufacturing process is ensuring that the manufacturing and test documentation used matches the approval documents. This regulatory compliance must also be monitored in a suitable manner.
In the area of GMP we offer the following audit types:
- on study, on process
- pre-qualification audit
- qualification audit
- master cell bank, working cell bank
We would be happy to support and advise you individually as part of the implementation of your audit/audit program.