GMP NEWS 2020

The USP General Chapters—Packaging and Distribution Expert Committee is proposing a new general chapter <668> Cured Silicone Elastomers for Pharmaceutical Manufacturing and Packaging Components.

EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use.

The FDA published a new guideline on Adaptive Design Clinical Trials for Drugs and Biologics.

The MHRA recently posted three top tips for protecting patients and staying compliant when introducing updates to patient information leaflet.

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.

Report indicates persistent challenges and concerns with FDA foreign inspections.

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).