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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.
October 25, 2017
The M&A advisory firm has developed an interactive map of manufacturing sites to give insight into the market size of global manufacturing.
October 24, 2017
The agency has published educational material for physicians promoting the benefits of biosimilars.
October 23, 2017
The company is recalling several injectable products because of possible microbial contamination.
EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
October 20, 2017
The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.
This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.
October 19, 2017
How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?
October 17, 2017
The agency has published a continuity plan for its move from the United Kingdom.
October 16, 2017
Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.
The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.