The use of alternate methods, especially for USP methods, some of which are rather old, has long been a question that both the industry and the FDA have contemplated. Alternate methods can be easier to use and, in some instances, more accurate and reliable. But how can you demonstrate that an alternate method is indeed […]
In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory. The FDA takes refusal of inspection very seriously and the impact […]
For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.” The Q&A guidance contains five questions, along with the Agency’s current thinking on […]
It is paramount that a Quality Control laboratory has a calibration and preventative maintenance program for the laboratory instrumentation so that there is assurance that the instrumentation continues to be “fit for purpose” and that there is confidence in the accuracy and reliability of all analytical instruments. There should be a controlled, comprehensive list of […]
Take action now to assure that your facility information, drug listing information, and manufacturing sites are correct and that no changes have been made to any of these items or others that are listed in the FR notice due to publish on Wednesday (pre-publication notice here). The Notice indicates registrant’s responsibilities as follows: Each registrant […]
It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now. As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and […]
We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events. In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached. We can stream tv shows, live […]
Like death and taxes, eventually every pharmaceutical testing laboratory will get a regulatory agency inspection. The anticipation of a regulatory inspection will instill great angst even within the most compliant laboratories. The anticipated inspection might be a periodic inspection, but most often is a Pre-Approval Inspection (PAI). The anxiety about an impending inspection often triggers […]
The Report issued each year by the Office of Compliance (OC) is a treasure trove of facts and figures espousing the accomplishments of the OC. The 32 page document (which can be found here) provides a detailed account of OC actions in the enforcement arena, guidance area, consumer awareness and education area, actions relative to […]
On June 20, 2019, LCS’ President and CEO Fran Zipp, moderated a panel at the CPhI China exhibition in Shanghai, organized by Informa Markets. The panel discussion, “How Can International and Domestic Manufacturers Collaborate to Improve Quality?” included members from a number of different segments of the regulated industry. Members on the panel were: Aurelio […]
