BioPharm International, Regulatory Sourcebook March 2022

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

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

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

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

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.

Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.

Interoperability by 2023 depends on data standardization and systems compatibility between trading partners.

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.

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.