The FDA’s new guidance on Computer Software Assurance or CSA (here) marks a shift—one that prioritizes critical thinking, product quality, and patient safety. In the world of regulated life sciences, the validation of software has long been guided by strict requirements. For decades, companies followed traditional Computer System Validation (CSV) approaches, often focusing on generating extensive […]
The ICH Q12 Guideline complements ICH Q8 to Q11 Guidelines and provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. The Q12 guideline highlights the need for an effective PQS as described in ICH Q10 and in compliance […]
Let’s admit it, whether in our personal or working lives, change is hard! As a species, we like to stick with the known and what works for us. Do many of us switch between Apple and Android devices? Is there a brand of car, beer, or wine that we favor? Why don’t we try other […]
The USP has issued USP <1037> Process Analytical Technology – Theory and Practice, which is open for comments until the end of July 2025. This draft chapter is comprehensive and discusses the relationship between QbD and PAT, the fundamental requirements of PAT, PAT applications, and chemometrics, along with lifecycle management of PAT methods. The chapter espouses […]
Airflow visualization studies (AVS) (also known as smoke studies) are an integral part of contamination control practices in GMP-controlled aseptic processing plants. As per regulatory guidelines such as the FDA’s 2004 Guidance on Aseptic Processing (here), USP <1116> (here), and PDA Technical Reports 13 (here), 22 (here), and 34 (here), these studies enable the measurement […]
Today, the FDA announced the “Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities” (here), signaling that the Agency appears to be leveling the playing field between domestic and foreign facility inspections. According to the comments in the May 5, 2025 Regulatory Affairs Professionals Society (RAPS) Regulatory Focus article by Joanne S. Eglovitch (here), the “unannounced foreign […]
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 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 […]
An aspect of contamination control is the assurance that residual material is not carried over into successive batches by incomplete cleaning of equipment. Cleaning procedures (both the cleaning process and the analytical method to verify cleaning effectiveness) to provide this assurance should be validated. Sampling of equipment for the purpose of cleaning validation or cleaning […]
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 […]
