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July 12, 2019
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
July 10, 2019
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
FDA released draft guidance on using the USP pending monograph process in the drug application process.
July 03, 2019
FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.
July 02, 2019
Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
Today’s inspection systems catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?
June 25, 2019
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
June 24, 2019
Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.