GMP for ATMPs

GMP training for ATMPs

GMP for ATMPs

If you like to know what kind of GMP compliance services we offer for ATMPs, call +49 69 7909 343.

Our specialists will be happy to support you.

 
Content

ATMPs need special GMP service support

Advanced therapy medicinal products, (ATMPs) need special directives due to the huge heterogeneity of the products and the extreme variable development and manufacturing environments.

ATMPs are produced in small batches for personalized therapies only and even the manufacturing process is mostly still in development.

For this reason european regulating agencies under the hat of the EMA discussed a special GMP for ATMP guideline, which accommodates the features of manufacturing ATMPs.

The „Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products” was adopted by the European Commission at 22th of november 2017.

Valicare GmbH is well versed with the actual directives and offers accompanying consulting at the highest professional stage.

We transfer your specific lab protocol into GMP-compliant manufacturing processes and work out the specifications for your ATMP.

Additionally we prepare or support you with the preparation of the manufacturing documentation and the master documents, offer ATMP trainings and audit & inspection service.