Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.


FDA Maps Strategies to Advance Pharmaceutical Quality

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

Steven J. Lynn is executive vice-president, pharmaceuticals for Regulatory Compliance Associates, Inc.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Verifying Compendial Methods

Feliza Mirasol is the science editor for 

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

In-Use Testing of Cleanroom Garments

Grant Playter is the Assistant Editor for 

Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.

Contextualizing Computer Validation

Mark White, PhD, is the associate director of Biopharma Product Marketing at Bio-Rad.

Marwan Alsarraj is the Biopharma Segment manager at Bio-Rad.

CAR-T cell therapy development is a complex process that requires standardization.

Assessing the Quality of CAR-T Cells Using ddPCR

Editor of Pharmaceutical Technology Europe

As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.

The Data Relationship

Courtney Soulsby is sector director, Healthcare & Life Sciences, BSI.

A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines. 


A New Route to Pharma GDP Compliance and Standardization 

Peter Zipfell is product marketing manager, CDS Software, at Thermo Fisher Scientific.

Michelle English is Data Science product manager at Protein Metrics.

The integration of modern software tools can make the acquisition and analysis of MS data more efficient, accurate, and compliant.

Connected Software Solutions Streamline Biopharma MS Workflows

Build into the chemistry, manufacturing, and control strategy the ability to pivot and be flexible should the course change.

A Customized Regulatory Approach to CMCs

Susan J. Schniepp, distinguished fellow at Regulatory Compliance 
Associates, details regulatory requirements for developing a quality manual. 


Quality Control/Quality Assurance