In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in…
The FDA flagged three U.S. facilities for a variety of noncompliances observed by agency investigators during inspections, including issues with labeling, failure to properly handle complaints and reporting of adverse…
Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of…
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, according to a high-ranking agency official. Source: Drug GMP Report
The FDA warned four companies for illegally branding cannabidiol products as treatments for cancer and Alzheimer’s disease. Source: Drug GMP Report
The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act. Source: Drug GMP Report
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Source: Drug GMP Report
The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft. Source:…
Problems with handling complaints, maintaining sterile production conditions and following up on testing crop up in reports of on-site inspections. Source: Drug GMP Report
Makers of APIs, compounded drugs, and dietary supplements draw warnings from the agency for a variety of GMP and other violations. Source: Drug GMP Report