CGMP Resources

At PCGI, we strive to be the 3rd party Regulatory Compliance Consultant firm of choice for Pharmaceutical companies around the globe. Our core value is that we believe people with passion can  change the world.  To be and think differently. Our goal is to support Pharma companies establish compliance that is sustainable.  

Free Webinar - Inspection Readiness / 

March 3, 2022 @ 11AM Eastern
Register Free Here: https://bit.ly/3HzmRvU

FDA requires firms to maintain CGMP compliance and be able to host an unannounced inspection upon their arrival. Preparing for such regulatory inspection can feel overwhelming. Inspection readiness refers to the ability of an organization to operate at a level that allows for effective preparation to host an inspection and demonstrate CGMP compliance.

At this free webinar, we will discuss the strategy and approaches to reach and maintain the quality of Inspection Readiness.

Webinar Agenda:
Part 1 - Understanding the Basics
Part 2 - Site Inspection Readiness
Part 3 - Role of GMP Consultants

A letter from US Congress (dated December 13, 2023) to USFDA follows up on the July 2023 request for information on the investigation regarding the agency’s inspection program. https://lnkd.in/eCqiWqsc.
To date, the FDA has not provided any response to the Committee’s previous request for information including inspections in China and India. Per letter, FDA ended its unannounced foreign inspection program because the agency believed it was an obstacle to deeper collaboration with India. The same reporting also alleges that the FDA undermined a Department of Defense initiative to independently test the quality of imported drugs used by the military out of fear that it would undermine the FDA’s credibility.  Newly published study confirmed the FDA 2022 foreign inspections was down 79% compared to 2019 while at the same time the number of “citations rose dramatically, despite all establishments being given advance notice of inspections.”
Congress is prepared to issue a subpoena if the FDA does not produce the requested documents by January 5, 2024, six months from the original due date. As a comparison, inspected firms are required to provide responses to 483 observations or Warning letter citations within 15 business days.