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 to harmonize standards within the industry.
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 news reporting and sports events in real time.
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 a request for an independent third-party audit of the facility including the laboratory.
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,
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 Arias,
For those of us in the regulated industry, we rely on FDA’s website for many different things. FDA.gov has historically been not the most intuitive website, with all of the Centers running their own pages, and inconsistencies occurring as a result of having many “chefs in the kitchen”, as the saying goes. On April 26,
From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week. The report on price fixing was met with a response to 60 Minutes May 12,
Browsing the daily articles is always fun, whether it is trolling for stories of interest or for something that just makes you want to start banging your head against your keyboard. Today I read an article (here) from the Times of India’s business section. It outlined the number of approvals from Indian-based companies,
Well, for us old folks, change is always something that makes us queasy. The newly-designed FDA website stirred those feeling all over again as we try to navigate the new links and find the information that was once at our fingertips (or at least in our bookmarks). There were some wrong turns and some dead links along the way,
Back in 2016, FDA indicated that it was planning to issue a guidance document to explain to firms how to extend expiration dating for doxycycline tablets and capsules held in national stockpiles (here) . Doxycycline is stored in national stockpiles for treatment of post-exposure prophylaxis (PEP) or treatment of inhalational anthrax in the event of an anthrax emergency.
As always, Lachman Consultants looks to provide excellence in all phases of serving our clients’ needs, so we paid close attention to the various speakers, panels and general goings-on at the 2019 ISPE Europe meeting to take the pulse of the industry. We also spoke to many of the show’s attendees, and the takeaways from our many observations and conversations covered a variety of topics.
As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs. As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the public if not prepared properly.
In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products. The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over twenty-five years (twenty‑seven years now).
As many dietary supplement marketers are essentially virtual companies, all manufacturing and testing is performed by organizations contracted by the marketer. In the ten years or so since the dietary supplement GMPs went into effect, control of these contractors has been an ongoing challenge. Most dietary supplement marketers have demonstrated adequate control over their contractors,
Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product. One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station).