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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 16, 2021
April 15, 2021
This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.
April 14, 2021
Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.
This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.
April 13, 2021
CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.
April 09, 2021
Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.
April 03, 2021
Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.
Decontamination, automation, and containment are important considerations for aseptic manufacturing in isolators.
April 02, 2021
A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.