It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

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.

Digitalization of QbD Risk Assessments

Topic

Articles

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

FDA Releases Compounding Guidance

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly. 

FDA Warns of Rare but Serious Drug Reaction to Antiseizure Medicines

Feliza Mirasol is the science editor for 

Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.

Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL

The bio/pharmaceutical industry is struggling with the challenge of staffing and training.

Training for Operational Excellence

Kari Miller is senior director, Product Management, QMS, IQVIA.

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

Revitalizing Quality Management Processes through Digitalization

Kate Coleman is Principal Quality and Compliance Consultant with Arriello Ireland.

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.

The ICH Q9 Revision and a Renewed Focus on Quality Risk Management Fundamentals 

Cheryl Barton is director of PharmaVision, 

Renewing the UK Voluntary Pricing Scheme 

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA and industry face unprecedented political and policy challenges.

Signing Off from Washington 

Mike Hennessy Jr. is the President and CEO of 

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

The Dislocation of Progress

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments