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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 02, 2019
FDA readies more efficient oversight processes while advancing collaboration with Europe.
It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.
October 30, 2019
A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.
October 28, 2019
The company is recalling Alprazolam Tablets, USP C-IV 0.5 mg because of potential presence of foreign substance.
October 25, 2019
The agency’s implementation of the SUPPORT Act has included new guidance documents and actions to restrict illicit drugs entering the US.
October 24, 2019
Dr. Reddy’s, Sanofi, and Perrigo Company issued voluntary recalls of ranitidine in October 2019 because of N-Nitrosodimethylamine contamination.
October 21, 2019
The agency announced it has approved 1171 generic drugs in fiscal year 2019.
The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.