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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.
August 10, 2022
FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.
Democrats approve curbs for Medicare plans, but not for commercial drug coverage.
August 09, 2022
The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.
August 04, 2022
Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.
Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.
August 03, 2022
A comprehensive understanding of potential material change can mitigate its impact on patient safety.
The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.
This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
August 02, 2022
Successful digital transformation in biopharma requires an integrated approach to the data lifecycle.