GMP Compliance Services for Pharmaceuticals
Good Manufacturing Practice, or GMP, is a set of regulations issued by the US Food and Drug Administration under the Federal Food, Drug and Cosmetic Act.
They require processors, manufacturers and packagers of medical devices, drugs and foods to take proactive steps towards ensuring the safety, effectiveness and purity of their products. These regulations ensure quality approach and practices to reduce (or remove) errors and contamination, in order to protect consumers.
GMP Inspections – Types and Objectives
To keep inspections relevant, GMP processes are categorized according to several types, each with different objectives:
Pre-Approval Inspection (PAI)
The primary objective is to confirm readiness for commercially manufacturing a product, and investigations include:
• Ma...
