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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.
September 14, 2016
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
The agency provides a qualified context of use for the biomarker plasma fibrinogen.
September 12, 2016
Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.
The company voluntarily recalled the product due to detached needles on the syringe in the kit.
The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.
September 08, 2016
A customer complaint revealed microbial contamination issues affecting lots with expiration dates in late 2018 and early 2019.
Mumbai, the location for its new Indian subsidiary, will also be the site for the company's Uniquity Global Conference on October 6, 2016.
September 07, 2016
FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.
The Indian facility was cited for a range of quality and data integrity violations.
The agency published a guideline for the implementation of ICH Q3D.