Quality/GMPs

Articles

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference. 

Being Innovative in CGMP Training While Adapting to Change 

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

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

Clearing Up Confusion in Inspection Terminology

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities

Feliza Mirasol is the science editor for 

Advanced analytical tools generate more data in today’s labs than ever before.

Dealing with Data: How to Keep It Manageable

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of BioPharm International's Editorial Advisory Board.

The more information shared, the smoother the approval process, says 
Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.  

Sharing Critical Information for the Best Outcome

Suzanne Shelley is a contributing editor to 

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships. 

Protecting High-value Biologics at Every Turn

 Washington Editor, jillwechsler7@gmail.com.

Problems continue despite actions by regulators to better prevent and address drug shortages.

Drug Shortages Continue to Plague FDA and Manufacturers

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

The Inspection Result: Warning Letters and Form 483s

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

MilliporeSigma Invests €35 Million to Strengthen Biosafety Testing in Scotland

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Quality Control/Quality Assurance