Quality/GMPs

Mike Wilson, QA/QC Strategy, Waters Corporation

Articles

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

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

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. 

Creating a Contamination Control Strategy

 Washington Editor, jillwechsler7@gmail.com.

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

Rising Demand Drives Drug Shortages

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

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

Controlling Quality in Aging Facilities

Tareq Jaber, tareq.jaber@crl.com, is associate director at Charles River Laboratories.

Anja Tessarz, Anja.Tessarz@crl.com, is associate director RGDB, SME Viral Clearance at Charles River Laboratories.

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

Viral Clearance Studies: Challenges and Beyond

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

Quality Control/Quality Assurance