GMP expert Jerry Chapman covers how Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence.
This week, there were a total of five issued warning letters: three were issued to drug manufacturers, one to a compounding pharmacy, and one to a device manufacturer. The first one issued to Deva Holdings addresses severe penicillin cross-contamination.
GMP expert Barbara W. Unger analyzes the major initiatives put forth in CDER’s Office of Compliance Annual Report for CY2018.
We cover three GMP drug warning letters and a warning letter to a large CBD firm for misbranding and distribution of the unapproved new drug. FDA did not agree with the firm’s statement that the product was a dietary supplement.
FDA published three drug warning letters this week, one of which was issued in April and one that found a firm to be shredding GMP documents.