CHMP's Assessment Report on Nitrosamines published
The recently published final assessment report of the CHMP describes in great detail the state of knowledge on nitrosamines in human medicinal products. All you need to know about risk assessment, calculation of limit values and analysis of nitrosamine contamination can be found in this document.
Revised Ph. Eur. Raman Spectroscopy Chapter published for Public Consultation
The European Pharmacopoeia (Ph. Eur.) has published the revised chapter 2.2.48 on Raman Spectroscopy for public consultation. All interested users are encouraged to review the draft and submit their comments from July to September 2020.
Dissolution Test for Solid Oral Dosage Forms: WHO publishes Draft for Comments
The World Health Organization (WHO) has published a draft proposal for revision in The International Pharmacopoeia. The document entitled DISSOLUTION TEST FOR SOLID ORAL DOSAGE FORMS will be posted on the WHO Medicines website. The deadline for comments is 31 August 2020.
Extractable Elements in Plastic Materials - Extended Deadline for Comments
The drafts for the new Ph. Eur. chapters on plastic packaging materials (COP, COC, and Extractable elements in plastic materials for pharmaceutical use) have been re-published in Pharmeuropa to give stakeholders sufficient time to comment.
FDA Warning Letter for Canadian Drugmaker - HPLC and Data Integrity in the Focus
The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.
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.
FDA Warning Letter: Lab Data Integrity still in the Focus
The U.S. FDA issued a Warning Letter to the US American contract testing laboratory “International Trading Pharm Lab Inc” due to significant violations of cGMP regulations and the inaccurancy of electronical data for Active Pharmaceutical Ingredients (APIs).
Update on COC / COP and Extractable Elements in Plastic Materials
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 USP Cannabis Expert Panel has published an article on the quality requirements for medical cannabis in the Journal of Natural Products. The article describes the appropriate use of USP General Chapters related to chromatographic methods and controls for contaminants.
FDA Warning Letter: No Compendial Methods established? Develop appropriate Testing Procedures by yourself!
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.
FDA Warning Letter: Incoming Analysis of Raw Materials - Performing only an Appearance Test is not enough
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.
Shredding Key Documents and Leading Investigators to Incorrect Rooms - An unusual FDA Warning Letter
FDA Warning letters often refer to insufficient documentation, missing validations, inadequate training, employees not following procedures, or similar cases. But shredding documents and leading investigators to incorrect rooms during an inspection is rather unusual.