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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.
March 01, 2017
This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.
February 28, 2017
Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
February 27, 2017
FDA plans to initiate its quality metrics program as industry continues to push back.
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
February 24, 2017
The agency’s CHMP recommended six drugs for market approval, including one orphan drug, during its February meeting.
The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.
In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.
February 23, 2017
The authors discuss regulatory and patent issues with combination products.
The district court ordered Pick and Pay Inc./Cili Minerals to cease operations after it unlawfully manufactured and distributed unapproved new drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements.