Though the FDA had indicated previously that it would not extend the deadline for full implementation of Drug Supply Chain Security Act (DSCSA) requirements, discretion appears to have become the better part of valor. On June 13, 2024, we posted a blog about waivers that would be available for certain small dispensers, and yesterday the FDA […]
Last week, my colleague and I traveled to Bangalore to attend the PDA India Chapter’s meeting on Supply Chain Resilience & Quality Management Maturity. While I was intellectually aware of the important role that India plays in the global supply chain for pharmaceuticals, during my 2½ days at this chapter meeting, I was able to […]
From September 18 to 20, 2024, I was pleased to attend the PDA India Chapter conference on Quality Management Maturity and Supply Chain Resiliency, and I was impressed with the number of people who took three days out of (what must be) busy schedules and demanding jobs in the Indian pharmaceutical industry to attend. […]
Day 2 of the 2024 PDA/FDA Joint Regulatory Conference kicked off in a similar format to Day 1 with a panel discussion, moderated by Andrew Hopkins, that delivered key messages from various FDA leaders. An explanation of the imminent changes in the Agency’s organizational structure (CBER, CDER, and CVM) dominated the conversation. However, an impactful response from […]
It’s been a pleasure to return to the PDA/FDA’s 2024 Joint Regulatory Conference. This is the first FDA co-sponsored conference that I’ve attended since my retirement from the Agency in 2023, and it has a bit of a high-school-reunion atmosphere for me. I’m grateful for the friendships with my FDA colleagues that have extended beyond […]
CAPAs are one of the most important elements of the pharmaceutical Quality System. During Day 1 of the PDA/FDA Joint Regulatory Meeting, Jonathan Chapman, Senior Policy Advisor at the FDA, spoke about CAPAs. Traditionally, we think of CAPAs as follows: Corrective actions are actions implemented to correct an identified problem. Preventive actions are actions implemented to […]
The WHO has a draft July 2013 guidance document titled “Deviation Handling and Quality Risk Management” that addresses the concept that not all Quality Events are equivalent and provides consideration for the classification of events. For example, an incident would be an event that does not: “…affect a product attribute, manufacturing operational parameter or the […]
In the world of subjective tests, it can be difficult to investigate when things go wrong or when analysts have a different view of an appearance test. For example: The titrimetric test has an endpoint of blue-green, according to USP. The new analyst obtains an OOS result. The experienced analyst says the endpoint color should […]
A couple of months ago, when we returned from Barcelona to San Francisco, it was impossible to check in online for some reason. Then the news broke about flight disruptions due to the CrowdStrike software update! Some flights, including ours, were only a couple of hours delayed. However, many more passengers were affected even further […]
The FDA’s long-awaited QMSR will be released in February 2026. The amended 21 CFR 820 will incorporate by reference the Quality Management System (QMS) requirements of the 2016 edition of ISO 13485. We will explore the key differences between an FDA inspection and a notified body audit as well as the distinctions between ISO 13485 and the QMSR. […]
