FDA Explains the Expectations from cGMP Compliant Facilities
[Thursday, August 29, 2019]
FDA expects all manufacturing facilities, big and small, new and old, to be equally compliant to its GMP requirements, but it is often hard for the new manufacturers to prioritize the various areas of compliance to be meet FDA’s expectations. In a recent conference presentation, FDA’s leaders from the Office of Pharmaceutical Quality presented a list of minimum cGMP expectations which were summarized in a blog. FDA expects cGMP facilities to have good cleaning procedures, process control, well-defined CAPA, well-qualified suppliers, good maintenance of equipment, SOPs for process transfer, good procedures to address customer suggestions and complaints, and established practices to conduct due diligence audits of its suppliers. These suggestions are in line with the regulatory requirements described in 21CFR chapters and various Guidance Documents. However, the emphasis by FDA provides common sense measures that all organizations can implement to reduce risk. FDA has long advocated risk-based approaches to compliance and these suggestions highlighted the areas that FDA finds to be common contributors to non-compliance. Addressing these early on could help organizations come up to speed quickly in their operations with regards to cGMP compliance.