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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.
January 02, 2020
Regulatory mandates, niche diseases, and patient-centric solutions have all impacted pharma packaging over the years and are expected to help shape the future of the sector.
Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.
December 18, 2019
The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.
Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).
FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.
The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.
December 15, 2019
The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.
This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.
An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.
An understanding of global and national pharmacopoeias is crucial to understanding change processes and access to different markets.