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News about GMP/cGMP

2017-12-21

EC: Draft to Annex 1 on Sterile Manufacturing Published

On 20 December 2017 the European Commission has published the long awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products”. The public consultation period is open from 20 December until 20 March 2018.

 

Since then, Annex 1 on sterile manufacturing has undergone a number of targeted updates. But the multitude of regulatory changes finally required the most extensive and thorough revision since the first publication took place in 1971.

This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow.

The key changes in short:

  • Introduction of new sections: scope, utilities, Environmental and process monitoring sections and glossary
  • Introduction of QRM Principles
  • Introduction of new technologies such as closed single-use and disposable systems
  • Restructured to give more logical flow
  • Added detail to a number of the previous sections to provide further clarity.

The proposed revised version was prepared in cooperation with WHO and PIC/S. If you are interested in taking part in the public consultation you will find detailed information here.

We will shortly provide you with a detailed analysis of the Draft Annex 1 in our Newsletter Logfile.

Source: EC: Public Consultation

Comments
How we will provide our comment for Annex 1 EMA?
Dr. Ashfaq Khan 2018-03-07
 
Thank you very much for your comment/question on our news on the new draft of Annex 1 of the EU GMP Guide. Please refer to the Webpage of the European Commission concerning the targeted stakeholders consultation. Here you can find the template for comments as well as the email address where you can send your comments to: https://ec.europa.eu/health/human-use/quality/developments/pc_2017_12_sterile_medicinal_products_en
Editorial Office GMP Publishing 2018-03-08
 
In paragraph 8.18 100% integrity test is defined for containers closed by fusion, while in paragraph 8.90 is written „….simultaneously filling the formed bags with product and sealing the filled bags in a continuous process. All such containers are considered to be sealed by fusion and, as such, fall under the requirement to perform 100% integrity testing….“ Do the terms closed by fusion and sealed by fusion have the same meaning?
Ivona Capjak 2018-03-22
 
Thank you very much for your interest in our news/newsletter and for your interesting question regarding 8.18 and 8.90 of the draft of Annex 1 EU GMP Guide. To my understanding the terms “closed by fusion” and “sealed by fusion” have the same meaning. Thus, all such containers (closed or sealed by fusion) fall under the requirement to perform 100% integrity testing.
Editorial Office GMP Publishing 2018-03-23