EMA issues new annexes and guidances

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: Services|