FDA Enforcement Trends

FINAL Part 3: Invisible Ink in GLP and GCP Research

“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”

The New FDA GMP Inspection Model

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.

Part 2: Invisible Ink in GLP and GCP Research

“When I started in the industry back in 1990, I was a statistical programmer. While none of us used the phrase ‘data integrity,’ the way we worked helped ensure data integrity.” This post dives deep into these questions: What game changing regulatory action happened in 1997? Why do we validate computer systems? Are there any regulatory provisions for draft GLP or draft GCP data?

Invisible Ink in GLP and GCP Research

I believe we’ve stepped off the trail to data integrity and that we’ve been lost for a while now. It’s time to stop, take our bearings, and see if we can work toward agreement on where the trail to data integrity is. It’s my hope that this post will help start a much needed conversation, which can be continued back home at your companies and with your service providers.

Week of July 15th 2018 | FDA Sent These Warning Letters to Pharma Companies

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.

Week of July 8th 2018 | FDA Sent These Warning Letters to Pharma Companies

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 15th 2017. FDA suggests they employ consultant(s) to assist them in coming into GMP compliance in their manufacturing of APIs. Deficiencies include but are not limited to: The firm failed to adequately investigate and [...]