I just had an article describing the Compounding industry and what the FDA is doing about it. Here is the link.
The Calcott Consulting Blog:
During the last few months the European Medicines Agency (EMA) has issued a series of revisions to Annexes and Guidances
Specifically, the following
Annex 15 – Validation and Qualification
Annex 16 – Certification by a Qualified Person and Batch Release
Annex 17 – Real Time Release Testing
Guidance to Industry: Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
To understand what they contain and what it means, I refer you to an article I wrote recently in
Guidances have been issued by the FDA and EMA for over three years now. So are companies complying or are they finding it tough? Read an article I wrote in Contract Pharma Article. Happy reading
Single use components have been used in operations for decades but their use is expanding rapidly. The agencies are taking a closer look. Just published an interesting article on the topic in BioPharmaceutical International . Enjoy the read
All articles seen to focus on how to set up successful relationships with CMOs. What do you do if it begins to go south and prevent it happening again?January 14th, 2016 by Peter Calcott
Just published an article in Medicine Maker (Medicine Maker article). The focus is to identify when and if a relationship goes south. It identifies the issues and how to avoid getting trapped. Happy reading.