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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.
October 17, 2019
Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.
Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.
October 11, 2019
Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).
October 10, 2019
In an Oct. 10, 2019 press release, ChargePoint Technology announced that its smart monitoring system, Verifi, is now available for the biopharma market.
October 02, 2019
FDA and DEA warn four website operators to stop illegally selling opioids.
Climbing out of a reputation hole starts with adopting a quality culture.
A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.
Falsified documents and manipulated test results prompt warnings and investigations.