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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.
May 07, 2018
Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
The data and analytics company reports on the anticipated uptake of Humira (adalimumab) biosimilars in the EU once they are launched in 2018.
May 02, 2018
Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
April 30, 2018
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
April 24, 2018
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.