Audit of API manufacturing is a key skill requirement for every Qualified Person
The Qualified Person (QP) Declaration makes it clear that the manufacturers of pharmaceutical and medicinal products have the prime responsibility for ensuring the quality of active substances in terms of GMP compliance and prevention of falsification. Hence the audit of API manufacturing is a key skill requirement for every Qualified Person.
RSSL is launching a new training course for QPs and auditors covering the specific requirements for auditing APIs, and is for those assigned to complete API audits and those QPs responsible for signing the declaration of GMP for APIs as part of the release to market of medicinal products. While some auditing training and experience would be preferable, it is not a requirement of attendance.
This course will provide the basic knowledge and skills to enable effective auditing/reporting of suppliers of APIs. It will focus on the requirements of ICH Q7 and EU GMP and the expectations of regulatory bodies both in the USA and Europe.
It will ultimately help auditors to verify the GMP compliance of all parties in the supply chain, to take steps to shorten the supply chain wherever possible, and to clearly demonstrate that each batch of active substance accepted by them for use in the manufacture of medicinal products has been sourced through this supply chain.