Our First GMP Facility - Delivered
We are delighted to announce that - last week - we delivered our first ever Good Manufacturing Practice / GMP facility design for a clinical stage biotechnology company.
Based in Greater London, the facility was designed to meet global regulatory requirements, including the correct good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S Food and Drug Administration (FDA).
While the facility awaits MHRA approval in the next few weeks, we look forward to working in the pharmaceutical industry and delivering many more such projects.
What is GMP?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product.
There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
Souce: ISPE
