Regulatory/GMP Compliance

May 14, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 11, 2018
The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.
May 10, 2018
By Pharmaceutical Technology Editors
The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
May 07, 2018
Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
May 02, 2018
Pharmaceutical Technology
The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.
May 02, 2018
Pharmaceutical Technology
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
May 02, 2018
Pharmaceutical Technology
Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
Apr 30, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
Apr 20, 2018
By Pharmaceutical Technology Editors
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
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