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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.
December 08, 2020
The product is being recalled because of Burkholderia cepecia contamination.
The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.
The agency published guidance on how sponsors of combination products can obtain feedback from FDA on scientific and regulatory concerns.
December 03, 2020
Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.
The collaboration addresses the need for risk mitigation plans in cell therapies.
Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.
The COVID-19 pandemic has pushed more pharmaceutical companies and regulators to use new technologies for remote quality audits and inspections.
Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.
USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.
December 02, 2020
The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.