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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 20, 2017
The agency is warning about the potential threat of respiratory depression in children who take medicines with codeine or tramadol.
April 18, 2017
In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.
Pharmaceutical Technology spoke with Brad Pedrow and Rajesh Singh of Deloitte Consulting to discuss serialization implementation, and what to expect as the DSCSA deadline approaches.
igital tracking of overall equipment effectiveness can improve efficiency.
April 17, 2017
FDA denies the NDA for the RA drug developed by Eli Lilly and Incyte, citing the need for more data.
April 14, 2017
Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Nighttime Baby Teething Tablets due to inconsistent amounts of belladonna alkaloids.
April 13, 2017
Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.
At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.
April 12, 2017
The agency cited the company’s India facility for batch failures and data integrity problems.
The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.