CGMP controlled Raw Materials – Regulations and Best Practices

• By: Staff Editor
• Date: July 17, 2018

CGMP controlled Raw Materials – Regulations and Best Practices

5155 Firms received FDA 483 between 10/1/2016 and 9/30/2017. One of the major reasons for issuing these FDAs was non-compliance with the regulatory requirements of cGMP controlled raw materials.  It is critical for personnel in the Pharmaceutical, Biotechnology, and Medical Device Industries to understand the regulatory requirements and best practices pertaining to cGMP controlled raw materials to gain approvals and make products safe for use.