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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.
July 10, 2019
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
FDA released draft guidance on using the USP pending monograph process in the drug application process.
July 03, 2019
The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.
FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.
July 02, 2019
Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.
Today’s inspection systems catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.
To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.