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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.
August 04, 2016
The report addressed how the agency might support medicine development for patients’ unmet medical needs.
The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.
A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.
The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.
FDA approved Natco and Alvogen’s generic Tamiflu to treat and prevent influenza.
August 03, 2016
Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.
August 02, 2016
Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.
Regulators and manufacturers address economic and ethical issues for scarce medicines.
A Q&A with FDA to gain insight on FDA's views of three-dimensional printing and its regulation in drug manufacturing.
Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.