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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.
April 20, 2018
A federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
April 19, 2018
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
April 18, 2018
The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.
April 16, 2018
A new report gives an overview of the work of the International API Inspection Program.
April 13, 2018
Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.
April 12, 2018
The Parenteral Drug Association’s Data Integrity Task Force helps industry members understand regulatory requirements for data integrity.
April 11, 2018
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.