Industry news
Aug
11
Reflection paper on the use of interactive response technologies (interactive voice / web response systems) in clinical trials
Public consultation opens
Aug
05
Reflection paper on risk based quality management in clinical trials
Public consultation opens
Jul
18
Revision of GDP guidelines
Public consultation opens on the revised guideline on good distribution practice of medicinal products for human use
Jun
14
Concept paper on Revising Chapter 8 of the EC guide to GMP to introduce risk-based concepts and to provide for more effective investigations and CAPA actions
The proposed guideline will replace the current version of Chapter 8. Deadline for comments 30 June 2011.
Aug
05
Q&A: Good Manufacturing Practice (GMP)
A new section added: EU GMP guide annexes - Supplementary requirements: Annex 11 Computerised Systems
Aug
05
Q&A: Good Manufacturing Practice (GMP)
"How can GMP compliance for active substance manufacturers be demonstrated?" has been updated.
"Which kind of GMP documentation is needed for an active substance manufacturer who performs sterilisation of an active substance?" has been added.
