Considerations for multi-product manufacturing facilities
Trishul Shah, Associate Director Business Development at PolyPeptide Laboratories Inc, reviews the considerations for the manufacture of active pharmaceutical ingredients at a multi-product facility.
The regulatory standards for approval of new drugs have increased as companies and agencies raise the bar and their expectations. In particular, regulatory agencies have become more stringent as more information and understanding on the impact of drugs and their interaction with biological systems becomes available. With the increased hurdles to approval and the necessity to extend the product knowledge base, more focus is being placed on specific areas of the drug approval process.
Speciality Chemicals Magazine 37.01 January 2017