GMP and Regulatory Expectations for Early IND Products

 What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. These new guidelines appear to […]

GMP Compliance for Pharmaceutical Laboratories

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory’s activities. Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various regulatory bodies. The aim of GMP compliance for a pharmaceutical laboratory is to ensure that Products must […]