The European Commission has adopted the new Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMP)
Accordingly with Health and Food Safety Directorate General , this new Guidelines, adapt the GMP requirements to the specific characteristics of ATMPs and address novel scenarios such as decentralised manufacturing, automated production, and reconstitution of ATMPs. The Guidelines take a risk-based approach, allowing manufacturers some flexibility in their processes and control systems, depending on the level of risk. In addition, the Guidelines describe the traceability data that ATMP manufacturers should keep for 30 years in accordance with Article 15 of ATMP Regulation (EC/1394/2007).
The adaptations introduced in the GMP framework for ATMPs continue ensuring a high level of quality for ATMPs and a high level of patient protection.
Find the entire document (published date: 2017-Nov-22) here
