Regulatory/GMP Compliance

Aug 16, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
Aug 15, 2018
By Pharmaceutical Technology Editors
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
Aug 13, 2018
By Pharmaceutical Technology Editors
Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine (Thyroid Tablets, USP) 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 10, 2018
By Pharmaceutical Technology Editors
Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.
Aug 07, 2018
By Pharmaceutical Technology Editors
The agency issued a draft guidance on developing new medication-assisted treatments for opioid-use disorder.
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
More consistent and reliable production processes are critical for advancing innovative treatments.
Aug 01, 2018
Pharmaceutical Technology
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
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