Quality Control/Quality Assurance

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.

Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

Variability instills consistency in advanced therapy medicinal products.

Advanced LC technologies can streamline the review process for LC equipment maintenance.

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA struggles to track shortages caused by a rise in demand.

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Health crises, political tension, and budget concerns were major challenges.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

Industry experts discuss best practices for certificates of analysis.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

CBER maps modernization plan to handle surge in research and applications.

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

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

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 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.

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

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

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.

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

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

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

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.