GMPs

Sep 28, 2017
By Pharmaceutical Technology Editors
The agency will require training for healthcare providers who prescribe immediate-release opioids.
Sep 28, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
Sep 28, 2017
By Pharmaceutical Technology Editors
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
Sep 27, 2017
By Pharmaceutical Technology Editors
The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.
Sep 25, 2017
Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.
Sep 21, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
Sep 19, 2017
By Pharmaceutical Technology Editors
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
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.
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