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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.
November 15, 2016
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing models.
November 11, 2016
The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.
November 09, 2016
What’s ahead for the healthcare and pharmaceutical industries?
November 04, 2016
The new facility will focus on formulation development, drug product analytical development, and quality control.
November 03, 2016
FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.
NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.
November 02, 2016
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.
Reliable, high-quality products require innovative analytics and production.