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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.
September 01, 2016
The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.
The CordenPharma Chenôve, France manufacturing facility completed an FDA Inspection with no 483s reported.
FDA found no observations during recent inspection of Regis Technologies manufacturing site.
Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
August 31, 2016
Sandoz won FDA approval for its biosimilar version of Enbrel.
August 30, 2016
The company is voluntarily recalling one lot of product due to a potential packaging mistake.
August 29, 2016
The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.
FDA issued a warning letter to College Pharmacy for multiple violations.