OR WAIT null SECS
August 02, 2019
European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.
Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.
July 17, 2019
A July article in Science suggests that FDA enforcement activities have dropped significantly during the current US presidential administration.
Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility.
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.