Quality Assurance/Quality Control

Aug 13, 2018
By Pharmaceutical Technology Editors
Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine after FDA issues import alert affecting the active ingredient.
Aug 10, 2018
By Pharmaceutical Technology Editors
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
Aug 02, 2018
Pharmaceutical Technology
A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Aug 02, 2018
Pharmaceutical Technology
The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
Aug 02, 2018
Pharmaceutical Technology
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
Aug 02, 2018
Pharmaceutical Technology
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Jul 23, 2018
By Pharmaceutical Technology Editors
The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.
Jul 23, 2018
Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.
Jul 19, 2018
By Pharmaceutical Technology Editors
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
Jul 19, 2018
By Pharmaceutical Technology Editors
The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.
native1_300x100
lorem ipsum