When a firm receives an FDA 483 finding of “does not follow Standard Operating Procedures (SOPs) for performing X GMP activity,” the immediate response is often to revise or update that specific SOP with more detailed instructions. While this might seem like the right thing to do for a quick fix, it is crucial to […]
Revision 2 of the FDA Guidance for Industry “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” was published on January 6, 2025 and it finalizes the previous draft version. This is a procedural guidance that applies to medical products regulated by CDER, CBER, CDRH, […]
How is your company reacting to threats in its supply chain and transforming risk into opportunity? In a mature application of Quality Risk Management (QRM), companies should lean into the political winds of “onshoring,” “nearshoring,” and “friendshoring” as these concepts have been stood up as well-discussed risk mitigations to the current drug shortage problems. These […]
Investigations have historically been among the most commonly cited observations in FDA 483s so a robust investigation strategy is an important element of any firm’s quality program. A strong investigation is supported by a thorough and complete evaluation of the major elements: root cause analysis, impact assessment and scope, historical analysis, establishment of CAPAs, and a […]
A few months ago in this blog, we discussed the suitability of analytical methods and how a firm needs to demonstrate that a method is fit for purpose and, with that determination, there needs to be an understanding of the measurement uncertainty (MU) associated with the reported results (from that method). This blog can be […]
Whether you believe synthetic data to be real or fake, the overall market for it is expected to grow from $351.2 million in 2023 to $2,339.8 million by 2030 (Synthetic Data Generation Market Forecast | Fortune Business Insights). This statistic can make the most hardened cynic’s ears perk up. But, surely, in our world of regulated medicinal […]
Some common FDA 483 citations pertaining to cleaning validation are regarding consistency in monitoring of cleaning and the complete documentation of cleaning. It is critical to implement a robust monitoring process that is supported by detailed documentation. Ensuring that the SOPs for all aspects of cleaning are clear, detailed, and contain illustrations (where appropriate) to ensure […]
The logbook is the original audit trail mechanism as predicated in Eudralex, Volume 4, Chapter 4, Section 4.31. Is it too simple to automate or are we addicted to the simplicity of using them? Regardless, the industry struggles to automate the review of one of the simplest controls. In 2024, there were twenty-nine inspectional FDA 483s due to the […]
The Code of Federal Regulations at 211.110 is titled “Sampling and testing of in-process materials and drug products.” This new draft guidance, issued by the FDA, is designed to assist drug product manufacturers in complying with this section of the regulations “to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related […]
On December 19, 2024, the FDA finalized its reexamination of its initial decision (on October 2, 2024) that the tirzepatide shortage had been resolved. This comes after compounders of the drug ran to court to challenge the Agency’s initial decision. The latest notice of the shortage’s resolution came yesterday in a declaratory letter (here), issued by the […]
