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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 02, 2017
The agency published an action plan to nurture innovation and drug development by SMEs.
The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.
The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.
Approval of breakthrough therapies requires expedited quality assessment.
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
May 30, 2017
The company was cited for cGMP violations at its Irvine, California facility.
May 24, 2017
The agency met with the representatives of the East African Community to discuss the creation of a networking agency.
May 23, 2017
CBER is moving forward with the development and approval of regenerative medicine advanced therapies.
FDA cited the facility for violations of quality management and data integrity CGMPs.