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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 04, 2019
In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.
January 03, 2019
FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.
January 02, 2019
Aurobindo Pharma USA, Inc. voluntarily recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP, and Valsartan Tablets USP because of N-nitrosodiethylamine (NDEA) in the final drug product.
Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.
Pricing pressures, investment volatility, and government disfunction greet Pharma in 2019.
This year promises to bring more focus on risk management and building a quality culture, says consultant Susan Schniepp.
Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.
FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.
Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.
While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.