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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.
June 03, 2019
The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.
June 02, 2019
FDA’s annual manufacturing report card shows more quality compliance is needed.
CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.
A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.
Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
May 30, 2019
The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.
As part of its work to combat the opioid crisis, the agency is considering fixed-quantity, unit-of-use blister packaging for certain immediate-release opioid analgesics.
May 29, 2019
FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.
May 28, 2019
The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.