Quality Systems

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.
Jul 16, 2018
By Pharmaceutical Technology Editors
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
Jul 12, 2018
By Pharmaceutical Technology Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Jul 10, 2018
By Pharmaceutical Technology Editors
Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.
Jul 05, 2018
By Pharmaceutical Technology Editors
The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
Jul 03, 2018
By Pharmaceutical Technology Editors
The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
Jul 02, 2018
Pharmaceutical Technology
Maintaining good quality control practices throughout the entire manufacturing process requires robust development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.
Jul 02, 2018
Pharmaceutical Technology
Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.
Jul 02, 2018
Pharmaceutical Technology
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Jul 02, 2018
Pharmaceutical Technology
FDA seeks more efficient testing to spur development of less costly biotech therapies.
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