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 […]
At least unofficially, it appears the August 2024 approval numbers for ANDAs have popped back up. As of the posting on the Daily approval listing (here) and the All approvals listing (here), there were 67 full approval actions, the second highest of Fiscal Year (FY) 2024 thus far, and 15 tentative approval actions. We will […]
Just 25 days before the end of Fiscal Year (FY) 2024, the official July statistics were just posted here. The two biggest items of interest to industry from these monthly reports are usually the number of approval actions, as well as the number of ANDA receipts so, let’s get the important stuff out of the […]
Today, the FDA issued a new immediately effective guidance entitled “Control of Nitrosamine Impurities in Human Drugs” that replaces the initial guidance by the same name that was issued on February 24, 2021. The new guidance can be found here. The industry has been awaiting the issuance of this revised guidance and the “FDA made […]
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 […]
For those of us that live in areas with seasonal changes, I’m sure everyone has experienced the telltale signs that autumn is right around the corner. These changes are subtle at first but soon gain significance and portend a future that looks different than the present. Individuals who carefully examine the FDA’s Paragraph IV (PIV) Patent […]
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. […]
Yesterday, the FDA announced the issuance of 14 new product-specific guidances (PSGs) and 54 revised guidances that provide the FDA’s current thinking on the requirements for bioequivalence testing for generic drugs (here). In addition, the FDA updated its list of planned PSG issuances (73 new PSGs) as well as the list of PSGs that it […]
Working in the pharmaceutical industry, you can sometimes hear science and compliance talked about as if they are separate and unrelated. Two examples of what can be heard: “Oh well, that is more of a compliance risk than a scientific concern.” “You need to consider the compliance aspect of that change and then the scientific […]
