The European Commission has recently adopted two new good manufacturing practice (GMP) guidelines, one fit with a deadline for compliance in May next year.
Manufacturers of Advanced Therapy Medicinal Products (ATMPs) have exactly five months to comply to the GMP guidance adopted by the Commission on the 22nd of November.
The new document provides guidance tailored to the challenging manufacturing issues associated with ATMPs which feature gene or cell based materials for medicinal applications. These requirements relate to approved products and those in clinical trials.
The commission details that manufacturers need to take a quality focused, risk based approach to protect the integrity of finished products.
Quality reviews should be conducted annually to verify the consistency of processes and identify areas for improvement. More extensive reviews need to be conducted for product lines manufactured at higher volumes.
“The risk-based approach permits the manufacturer to design the organisational, technical and structural measures that are put in place to comply with GMP -and thus to ensure quality according to the specific risks of the product and the manufacturing process. “
Considerations must be made for the fact that the academic/ hospital settings that these products are developed in are very different to those sites used to produce conventional medical products.
Flexibility
The commission is aware that because of the complexity and diversity of ATMPs, the risks to quality are likely to differ from product to product. Also, each batch may contain variability due to the biological materials used and the manipulation steps in the manufacturing process, for example the cultivation of cells.
The authority continues: “In laying down the GMP requirements applicable to ATMPs, it is necessary to recognize a certain level of flexibility so that the ATMP manufacturer can implement the measures that are most appropriate having regard to specific characteristics of the manufacturing process and of the product.”
The field of ATMPs is progressing rapidly with new manufacturing models emerging to combat challenges and, as the commission notes, these products are at the forefront of scientific innovation.
Access the GMPs for ATMPs guideline here
The GMP guidelines for the manufacture or import of investigational medicinal products for human use were also published earlier this month.
Access that GMP guideline here