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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.
March 06, 2023
Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.
March 03, 2023
The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.
This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.
Lipids aren’t the only important ingredients influencing stability and in vivo performance.
March 02, 2023
Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
Stockpiling excess inventory is no longer enough to respond to supply chain volatility.
Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.
Stepwise paediatric investigation plans aim to boost the development of medicines for children.
Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.
That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.