Validation and Compliance

Oct 02, 2015
BioPharm International
Can alternative approaches to the permitted/acceptable daily exposure be justified?
Sep 01, 2015
BioPharm International
The author discusses the current best practices in technical qualification of single-use systems.
Aug 01, 2015
BioPharm International
This article discusses cleaning validation of equipment dedicated to the production of a single API.
Jun 01, 2015
BioPharm International
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.
Mar 23, 2015
BioPharm International
By BioPharm International Editors
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
Feb 01, 2015
BioPharm International
Evaluating the assembly design process, manufacture, and use helps mitigate risk.
Jan 01, 2015
BioPharm International
The author presents opportunities and challenges in implementing the product lifecycle approach.
Sep 19, 2014
By BioPharm International Editors
GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.
Jun 18, 2014
By BioPharm International Editors
FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.
Jun 18, 2014
By BioPharm International Editors
FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.
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