The move to link inspectors to specific organizational units (i.e., drugs, devices, biologics) to more closely align with the Centers responsible for the products seems to have taken a turn back to a more generalist approach. According to a Pink Sheet article (here, subscription required) authored by Sarah Karlin-Smith and Derrick Gingery, the so-called “‘Simple […]
Congratulations! Your firm has just successfully manufactured a high-quality pharmaceutical or biological product and is ready to ship it to the next destination to get it into the hands of the people who need it. Take a moment… is your firm REALLY ready? Your firm’s product is either starting its journey in a global supply […]
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 […]
In today’s regulatory climate, avoiding an FDA Form 483 after an inspection isn’t necessarily a sign of success, it’s the bare minimum. True industry leadership in Current Good Manufacturing Practice (cGMP) goes beyond damage control. It demands a proactive, risk-based approach to quality that starts well before the regulator arrives for an inspection. The finalization of […]
According to an FDA bulletin (here), “the FDA is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.” A copy of the letter warning firms to remove misleading ads can be downloaded here. The bulletin says, “The FDA is concerned patients are […]
Yesterday, the FDA quietly posted another update to the CDER Nitrosamine Impurity Acceptable Intake Limits webpage. The latest update is not an extended timeline for submitting changes or new acceptable intake (AI) limits as might be expected but instead because CDER has become aware of an emerging issue related to small-molecule nitrosamine impurities such as […]
The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Compliance has implemented a new meeting for generic drug manufacturers that have received CGMP warning letters, offering a new avenue for a facility to obtain feedback on its remediation of warning letter deficiencies. As part of user fee negotiations under the Generic Drug User […]
The FDA has announced the establishment of a public docket to receive comments on issues related to accelerating the establishment of new pharmaceutical manufacturing facilities in the US. You can read the full docket announcement here. Not only is the Agency opening a docket for comment, but that same announcement included information on a public […]
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 […]
I recently had the honour to be invited to speak at the PDA India’s annual conference in Hyderabad. The event was well supported by the local India office of FDA in person and senior FDA personnel (including Carmela Rosa and Jose Melendez amongst others) virtually. It was great to see the FDA continue to support […]
