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© 2023 MJH Life Sciences and BioPharm International. All rights reserved.
© 2023 MJH Life Sciences™ and BioPharm International. All rights reserved.
May 18, 2023
The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.
May 01, 2023
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.
March 15, 2023
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.
March 01, 2023
Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.
February 01, 2023
Variability instills consistency in advanced therapy medicinal products.
January 11, 2023
Advanced LC technologies can streamline the review process for LC equipment maintenance.
January 01, 2023
A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.