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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
December 15, 2016
FDA’s Center for Drug Evaluation and Research makes plans for implementation of the 21st Century Cures Act that include patient-focused drug development.
December 08, 2016
Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.
December 07, 2016
The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.
FDA issued a warning letter to Interquim, SA for CGMP deviations at its Barcelona API facility.
Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.
December 02, 2016
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.
Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.
Pharmaceutical companies must see regulators as partners in their efforts to provide safe and effective therapies worldwide.
Pharmaceutical Technology reached out to the US Pharmacopeial Convention (USP) to get an understanding about how pharma manufacturers can get involved in developing industry standards.
Susanne Keitel, director of the European Directorate for the Quality of Medicines and Healthcare (EDQM), discusses the role industry plays in the development of pharmaceutical standards.