What is GMP?
Good Manufacturing Practice (GMP) is «that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use» (1).
GMP covers all aspects of our production from the donor horses, laboratories, product testing, equipment and vials to the training and personal hygiene of staff.
Why is GST GMP approved?
GST aims to obtain all standards set in human cell therapy and necessary for veterinary medicinal products development. The GMP certification was attributed to GST because of our standardised and good documented production process, our high production capacity, our semi-automated filling device, our European Pharmacopoeia compliant vials, our full traceability from ingoing to outgoing data, our badge release process and our independent Quality Control.(2)
What does GMP mean to the users/veterinarians?
GMP compliance guarantees the reproducibility of the quality of the production process and batch release test, thus standardised quality and sterility of the final product. Because of this standardised and well controlled production process, standardised products with similar therapeutics effects are expected.
Are all veterinary stem cell companies GMP approved?
No, GST is the only GMP approved veterinary stem cell company in Belgium and Europe for orthopaedic applications. Ask your supplier for the GMP number.
Production & GMP
Different aspects of GMP required monitoring & testing
2) EUDRAGMP VOLUME 4 ANNEX 1