GMPs

Sep 15, 2017
Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.
Sep 12, 2017
By Pharmaceutical Technology Editors
The agency is looking for industry input on best practices for continuous manufacturing.
Sep 11, 2017
By Pharmaceutical Technology Editors
FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.
Sep 08, 2017
Six years after the guidance, it’s time to change our quality assurance vocabulary.
Sep 02, 2017
Pharmaceutical Technology
When it comes to getting the best out of quality by design, timing is everything.
Sep 02, 2017
Pharmaceutical Technology
FDA works with industry on strategies for assuring high-quality regenerative medicines.
Sep 02, 2017
Pharmaceutical Technology
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Sep 01, 2017
Pharmaceutical Technology
Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
Aug 31, 2017
By Pharmaceutical Technology Editors
The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).
Aug 23, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
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