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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.
June 02, 2016
FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.
During its May 2016 meeting the CHMP recommended the approval of six medications in the EU, including three generic drugs, treatments for hepatitis C, and Type 2 diabetes.
Pharmaceutical Technology spoke with Melissa Topp, director of Global Marketing at ICONICS, about the latest in process analytical technology (PAT).
June 01, 2016
FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
Pharma has voiced strong opposition against Britain’s departure from the EU.
May 31, 2016
FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.
The company received a warning letter at its Latina facility in Sermoneta, Italy following a May 2015 inspection.
The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.