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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.
February 02, 2017
Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.
Reducing regulatory roadblocks requires more than the stroke of a pen.
The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
The authors look at challenges and considerations to continuously improve inspection efficiency.
February 01, 2017
In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.
FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.
Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.