Quality/GMPs

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Articles

Clear understanding of what exactly the biomolecule entails is essential.

Using Protein Characterization to Support Regulatory Submissions

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

ISPE Releases First Guide from its Advancing Pharmaceutical Quality Program

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

VMIC Adopts Lonza’s Paperless Quality Control Microbiology Platform

The collaboration addresses the need for risk mitigation plans in cell therapies.

Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress. 

Technology’s Role in QA/QC

Art Meisler is principal consultant at Daelight

Successful migrations require careful planning to meet business needs and maintain data integrity.

How To Execute Successful Data Migrations

Feliza Mirasol is the science editor for 

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Single-Use Sensors Increase Process Understanding

Complex manufacturing processes pose challenges for final product inspection needed to ensure product integrity at commercial launch.

Complex Manufacturing Processes Prompt New Inspection Methods

Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

Quality Control/Quality Assurance