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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.
February 23, 2017
The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.
February 22, 2017
FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.
February 21, 2017
The regulatory agency rejected the medication, citing various issues related to device use.
Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.
February 17, 2017
The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.
February 16, 2017
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.
February 15, 2017
Process conditions can corrode stainless-steel surfaces, necessitating corrective and preventive maintenance.
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.