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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.
January 02, 2018
FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.
Bio/pharma professionals manage expectations amid industry uncertainty.
Will business decisions and drug pricing policies help or hinder science and drug approval advances in 2018?
The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.
Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.
Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
Process validation is an extension of biologics development processes.
Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.