News from GMP Area

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European Commission, EC, adopts GMP for ATMP Guideline, 22th of November 2017

Today, the guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products was released by the EC. The new guidelines, developed after extensive consultation with stakeholders, EMA and competent national authorities, adapt the GMP requirements to the specific characteristics of ATMPs and address novel scenarios such as decentralised manufacturing, automated production, and reconstitution of ATMPs.

Guidelines on good manufacturing practice specific to advanced therapy medicinal products

 

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".