News from GMP area

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Medical cannabis is a medicinal product, 30th of July 2019

Its precursors (cannabis flowers and flower extracts) are starting materials and/or active substances in the sense of a legal pharmaceutical interpretation. For the cultivation and harvesting of the medicinal plants and the harvesting of cannabis flowers, the requirements of Good Agriculture and Collection Practices (GACP) apply. For further processing and manufacturing steps, the requirements of Good Manufacturing Practices (GMP) apply. Implementation and documentation of the resulting quality requirements are fundamental prerequisites for the distribution and, if necessary, import of the corresponding raw materials, intermediates and final products in Europe. Otherwise, there is no access to the European pharmaceutical market.

Valicare supports pharmaceutical manufacturers in the implementation of quality requirements. Due to the large number and the spectrum of the inquiries, we offer every level of support requested by the customer, from the basic package of services for ensuring GACP and (above all) GMP compliance of the manufacturing steps to "full service" project consulting and support.

Take a look at our concept for "GMP production and packaging of cannabis flowers" and decide to what extent we should support you.

 

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".