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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.
April 02, 2020
As the coronavirus pandemic unfolds, Pharma must practice science over hype.
With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.
Pharmaceutical Technology spoke with Jens Andersson, purchasing director at Cambrex Karlskoga, about the best way to ensure the security of the bio/pharmaceutical materials supply chain.
Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.
April 01, 2020
With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.
Tools help improve understanding of excipient risk in formulating OSD drugs.
Understanding European GMPs and new rules from China for excipients are crucial for formulating solid-dosage drugs.
March 30, 2020
The bill includes multiple less-noticed provisions to bolster healthcare programs and to advance the development of new treatments and preventives to combat the virus.
March 27, 2020
Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.
March 20, 2020
FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.