Stability tests on finished medicinal products and their components, active ingredients and excipients, are an essential part of GMP-compliant manufacturing. Please read more here
Every change to an entry in a document should be signed and dated. Despite the change, the original information should remain legible. Please read more here
On 31 January 2025, the transition from the Clinical Trial Directive 2001/20/EC (CTD) to the Clinical Trial Regulation (EU) No 536/2014 (CTR) will end. Read more about the consequences for Qualified Persons (QPs)
