The United States Pharmacopeia is currently introducing some changes to the format of the USP and to its Pharmacopeial Forum - a bimonthly online journal in which USP publishes proposed revisions for public review.
The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.
A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.
The U.S. Food and Drug Administration (FDA) recently warned Teligent Pharma, Inc., for different significant violations of current good manufacturing practice (CGMP) at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate out-of-specification (OOS) test results.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during a 5-day inspection of the company's manufacturing facility in Malaga, Western Australia. The core issue is the non-compliance with requirements specified in the United States Pharmacopeia (USP).
A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of Pharmeuropa. The scope of this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and herbal medicinal products.