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News from GMP area

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Content

The new Annex 1 draft of the EU GMP guideline, 28th of February 2018

The new Annex 1 draft of the EU GMP guideline "Manufacture of Sterile Medicinal Products" was published on 20th of December 2017 and is still under discussion until 20th of March 2018. An Annex 1 conference is scheduled on 8/9 May 2018 in Berlin.

Annex 1 has been completely revised in cooperation with the EMA, WHO and PIC/S.

Quality risk management (ICH Q9) is included now and the following changes are made: Completion of new chapters (scope, utilities, environmental and process monitoring sections and glossary), integration of new technologies as well as a restructuring for a better understanding and increased detail level. Valicare GmbH employers are experts for qualification and validation of aseptic lines and processes. They will support you in analyzing and implementing the new requirements.

 

Further information


 
Dr Claudia Papewalis is giving a GMP for ATMP training

GMP for ATMPs

If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".