While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.
The FDA posted 9 warning letters this week including 1 to a device manufacturer, 1 each to an API manufacturer and compounding pharmacy, and, finally, 2 to finished dosage form manufacturers.
An efficient summary of all things FDA/GMP related for the week of 7/29/18. FDA, EMA, etc. have picked up the pace for laws/published docs. Same with warning letters (5 issued). See the complete run down here.
A really slow FDA week — 1 letter to a compounding pharmacy (Gipsco Investment Corp) and 1 to a firm for misbranded unapproved drug marketing. We cover the compounding pharmacy letter consistent with past practices.
GMP enforcement citing data governance and data integrity has not diminished — expanding both the number of warning letters and their geographic distribution. We discuss the addition of 3 new focus areas and what our GMP expert is watching out for in 2018.
An efficient summary of all things FDA/GMP related for the week of 7/22/18. A slow week for laws, published docs (5 from the FDA), and warning letters (1 to a compounding pharmacy). See the complete run down here.
FDA posted 6 warning letters this week. Two were issued to firms manufacturing finished pharmaceuticals (bB BioCHem Laboratories Inc. and Claris Injectables Limited). We continue to include the follow-up actions that FDA identified for the firms. Both letters are covered in this post.
Weekly summary of laws, regulations, guidance, and concept papers from the FDA, as well as enforcement actions taken.
DRUGS: Zuhai United Laboratories Co. Ltd. (Guangdong, China) received a warning letter on June 27th 2018 based on the outcome of an inspection ending September