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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 02, 2018
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.
Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.
March 29, 2018
Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
March 27, 2018
Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.
March 23, 2018
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
March 20, 2018
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.