The Calcott Consulting Blog:


Compounding Centers get new and more regulations

October 25th, 2016 by

I just had an article describing the Compounding industry and what the FDA is doing about it. Here is the link.

EMA issues new annexes and guidances

June 21st, 2016 by

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

Pharmaceutical on line  and

Bioprocess on line

 

How is Process Validation progressing now that guidances have been issued?

March 1st, 2016 by

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 in biopharm – a regulatory perspective

February 4th, 2016 by

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

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.