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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.
October 20, 2020
FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.
October 16, 2020
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.
For planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.
October 15, 2020
Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
October 14, 2020
Oxular has been granted rare pediatric disease and orphan drug designations by the US FDA for its proprietary drug, OXU-003.
The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.