In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD.  A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a glimpse into what to expect in the future.  The conference was attended by approximately 80 attendees, with 31 total speakers including 10 from the FDA. Overall, the common themes were:

  • FDA inspection strategies post-Covid
  • Forward-looking agency priorities (both FDA internal and industry facing)
  • Warning Letter Trends
  • Focus on Manufacturing
  • Supply Chain Weakness
  • Informed business decisions with great quality mindsets

The FDA spent a considerable amount of time identifying lessons learned as they executed their responsibilities during the pandemic.  They recognized that in person inspection is the preferred method going forward, but they wish to utilize some of the practices developed during this time such as 704a4 document requests.  Both CDER and CBER laid out their continued 2022 priorities, and some interesting highlights were the focus on the supply chain that came under extreme stress by the pandemic.  Several agency publications and initiatives that were thematic were:  “Risk Management Plans to Mitigate the Potential for Drug Shortages Guidance for Industry” (here) and “Office of Pharmaceutical Manufacturing Assessment -OPMA” (here).   These topics naturally dovetailed into subsequent presentations such as visibility of Quality Metrics and Quality Management Maturity.  The increased dependency on good data for good decisions was evident in both presentations as well as offline conversations over beer and crabs.

As expected, Data Integrity featured prominently in a significant number of the talks, as well as supplier management.  Lachman Consultants are well positioned to meet these demands with our suite of Data Integrity offerings as well as LCS’s Third Party service management offering.  These fundamental issues were seen not just as “processes” but integral to achieving the FDA goal of “Patients expect safe and effective medicine with every dose they take.”  Wrapping up some of the themes were trends in warning letters (CBER) which included:  Buildings and Facilities, Equipment, Control of Components…Containers and Closures, Production/Process Controls, Lab Controls and Records and Reports.

Lastly, as many of the presentations were topic focused, a clear message formed for all.  The need for all the aspects of the quality management system need application to the entire supply chain.  Manufacturing is a key generator of product, but all the pieces must work together to protect the entirety of the end-to-end supply, up to the patient, every dose, every time.