The Calcott Consulting Blog:

   Articles on Process Validation:


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

 

Posted in Clinical Manufacturing, Commercial Manufacturing, FDA Guidance, GMP, News, Process Validation, Quality by Design, Quality Management Systems, Risk Management| Tags: |Leave a comment

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

Posted in Commercial Manufacturing, FDA Guidance, GMP, Process Validation, Quality Management Systems, Risk Management| Leave a comment

The new EU Process Validation Guidance and what it says

February 28th, 2013 by

The initial draft of the EU Guidance for Process Validation was released for comment and the comment period closed in October. So what has the thoughts on the new guidance since it was released? Read the linked article in Master Control on line journal for some insights.

Posted in Commercial Manufacturing, News, Process Validation, Quality by Design, Risk Management| Tags: |Leave a comment

Quality by Design in the Vaccines world

February 18th, 2013 by

In February I published an article on the topic of Quality by Design as it applies to the Vaccines World. This was based on a presentation at an IBC conference on vaccine development. As you might imagine, QbD has been slow in development of biologics but even slower in Vaccines. Check out the article on the IBC website

Posted in Clinical Manufacturing, GMP, Process Validation, Quality by Design, Risk Management| Tags: |Leave a comment

Quality by Design: is it only for the big guys?

June 6th, 2012 by

There has been a lot of discussion at conferences and on LinkedIn as to whether QbD is just for big Pharma and Biotech and whether smaller companies are being discriminated against.  This triggered me to write an article for Metric Streams, GXP Lifeline.  Enjoy

Posted in Clinical Manufacturing, Commercial Manufacturing, News, Process Validation, Quality by Design, Risk Management| Tags: |1 Comment