Quality/GMPs

Articles

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

FDA’s Office of Compliance Releases 2021 Annual Report

Chris Spivey is the editorial director of 

FDA is incentivizing drug manufacturers through higher data integrity requirements.

Data Integrity as Current Good Manufacturing Practice

Sue Marchant is senior vice president of Product at 

Data may be used to improve (or remove) a corrective action/preventive action.

Put a Cap on CAPAs

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

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. BioPharm International asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Technology and CAPA

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

Calvin Kim is the senior director, head of IT quality systems and validation, for Samsung Biologics.

Why critical thinking must be applied before technology to ensure regulatory compliance.

How a Lack of Critical Thinking is Hindering Regulatory Compliance

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 

James P. Stumpff, RPh, is principal consultant with Parexel International, jim.stumpff@parexel.com.

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

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

Remote Inspections - Lessons Learned

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of 

l's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

Rozaleen Dash is a post-doctoral fellow in the Department of Chemical Engineering at the Indian Institute of Technology (Delhi). 

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

Late-Stage Failures of Monoclonal Antibodies

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

Regulatory/GMP Compliance