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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.
November 15, 2018
The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.
The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.
November 14, 2018
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
November 12, 2018
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
November 09, 2018
The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.
November 08, 2018
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.
November 06, 2018
An ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.
November 02, 2018
Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.