Quality/GMPs

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Articles

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

FDA Sends Warning Letter to Arizona Facility

Editor of Pharmaceutical Technology Europe

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.

Optimizing the Manufacture of Emerging Therapies

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

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.

Measuring Quality in a Culture

Mike Wilson, QA/QC Strategy, Waters Corporation

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.

Mitigating Human Error and Supporting Compliance with Smart Technology

Amanda Guiraldelli is scientific affairs manager at the United States Pharmacopeia.

Jane Weitzel is an independent consultant and chair of the US Pharmacopeia Expert Committee on Measurement and Data Quality.

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


Evolution of Analytical Procedure Validation Concepts: Part I

Cliff Campbell is senior consultant at KPC.

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

Points to Consider for Knowledge Management Acceleration

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

Securing the Supply Chain with Good Distribution Practices

Chris Spivey is the editorial director of 

Variability instills consistency in advanced therapy medicinal products. 

Potency Assays for Novel Complex Modalities

Jon Bardsley is market development manager, Pharma & BioPharma, at Thermo Fisher Scientific.

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

Tools and Technologies for Robust Method Lifecycle Management in Liquid Chromatography

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

Quality Control/Quality Assurance