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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.
August 14, 2017
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
August 10, 2017
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.
August 08, 2017
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.
August 07, 2017
Featuring software, parallel automated reactors, and other tools designed to facilitate design of experiments, development of the design space, and better process understanding and control, the Hyderabad facility came online on July 20
August 04, 2017
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
August 02, 2017
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies.
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.