Drug GMP Report

The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products. Source: Drug GMP Report

Due in part to a high number of adverse events and recalls associated with contaminated products, the FDA has issued a 21-page draft guidance to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Source: Drug GMP Report

As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Source: Drug GMP Report

The FDA announced that it is developing guidance on compounding drugs during the COVID-19 pandemic to protect patients from “unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.” Source: Drug GMP Report

Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the recalls, a new report says. Source: Drug GMP Report

Like other parts of the FDA, the Center for Drug Evaluation and Research had to scramble last year to address COVID-19 while not losing sight of its other important tasks, according to its latest annual report on Drug Safety Priorities. Source: Drug GMP Report

Alembic Pharmaceuticals, a sterile drug manufacturer in Gujarat, India, drew a Form 483 inspection report from the FDA with five observations following a Jan. 28 – Feb. 6 inspection. Source: Drug GMP Report

A Government Accountability Office (GAO) review of COVID-19 vaccine development efforts found that vaccine producers are facing significant manufacturing hurdles as they scale up operations. Source: Drug GMP Report

Allay Pharmaceuticals, a contract drug manufacturer in Hialeah, Florida, drew a warning letter from the FDA arising from a May 5-15, 2020 inspection in which investigators found serious quality lapses, including a lack of validation for manufacturing processes and other problems. Source: Drug GMP Report

The FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to AcelRx Pharmaceuticals over false and misleading claims it made for its oral opioid Dsuvia (sufentanil). Source: Drug GMP Report