GMP News - Analytical Quality Control

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a US-based drug maker for significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the failure to investigate out-of-specification (OOS) test results and to follow proper documentation practices.

Three drafts for new Ph. Eur. chapters on plastic packaging materials have been published for comment in the recent issue of Pharmeuropa: Cyclo-olefin polymers (COP), Cyclo-olefin copolymers (COC), and Extractable elements in plastic materials for pharmaceutical use.

The general Ph. Eur. monograph on Essential Oils has been published for comment in the recent issue of Pharmeuropa together with a proposed new Ph. Eur. chapter 5.30. Monographs on essential oils.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Romania-based manufacturer of an unapproved new drug due to, among others, releasing drug products without conducting identity and strength testing.

The monograph "Cannabis Extract, Standardized" (Cannabis extractum normatum) will be added to the German Pharmacopoeia (DAB 2020).

The European Medicines Agency, EMA, as well as the EDQM have extended their deadlines for submitting risk evaluations for Nitrosamine Impurities in medicinal products by the Marketing Authorisation Holders.

The new chapter 5.17.2 in the European Pharmacopoeia "Recommendations on testing of particulate contamination: visible particles" was already published for comment in autumn 2018 (Pharmeuropa 30.4). The comments and feedback received have been considered by the Expert Group 12 of the EDQM, and the chapter is coming into force.