Regulatory/GMP Compliance

May 15, 2018
Pharmaceutical Technology
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
May 15, 2018
Pharmaceutical Technology
ASTM’s E-55.05 committee aims to turn best practices into industry standards in order to eliminate variability and allow a 70-year-old process to leverage 21st century tools, technologies, and practices.
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.
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