Quality Control/Quality Assurance

Regulatory Compliance Versus Real Compliance

October 01, 2022

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.

Real-Time Post-Apheresis Documentation Decreases Errors

September 15, 2022

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.

Best Practices for Developing a Third-Party Auditing SOP

September 01, 2022

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.

Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP

July 20, 2022

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

The Difference between Electronic Records Retention and Archiving

July 06, 2022

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA Advances Quality Initiatives to Combat Drug Shortages

July 01, 2022

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

EMA Adopts List of Critical COVID-19 Medicines

June 10, 2022

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

Using ddPCR to Assess the Success of CRISPR Gene Therapies

June 08, 2022

One get obtain a clearer assessment of gene-editing outcomes through more exacting analytical tools.

Early Strategizing Tightens Development Timelines

June 02, 2022

Having a clear clinical strategy early on can shave time off overall development projects.

Considerations for US Fetal Bovine Serum Sourcing

June 02, 2022

Extensive work has greatly expanded the possibilities for fetal bovine serum sourcing.