Drug GMP and CMC Updates In Brief: Guidance Advances on Several Fronts
Executive Summary
The US FDA revised two drug good manufacturing practice inspection programs in its compliance manual to reflect certain ICH guidance documents, efforts to control nitrosamine impurities and the use of inspection alternatives for evaluating facilities. Plus more recent developments in GMP and CMC compliance.
You may also be interested in...
Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate
Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages.
Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate
Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages.
CMC And GMP Updates In Brief: Continuous Manufacturing, Accelerated CMC Reviews
ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.