ICH - News

The PCI team never stops innovating. Stay informed about our latest achievements.

The Role of ICH and How to Meet Quality Guidelines in API Manufacturing

Tags: API Manufacturing | Blog | Compliance | ICH

Posted December 1, 2020
10 Strategies for Lowering Elemental Impurities in APIs

Tags: API Manufacturing | Blog | ICH | Impurities

Posted September 21, 2020
Setting Comprehensive Specifications in API Manufacturing

Tags: API Manufacturing | Blog | CDMO | ICH | Standard Operating Procedures

Posted January 16, 2018
API Quality Risk Management

Tags: Blog | CDMO | Cost | ICH | Quality Systems

Posted December 7, 2017
Best practices in following ICH guidelines for APIs

Tags: API Manufacturing | Blog | EMA | Equipment | FDA | How to select a CMO | ICH

Posted July 6, 2017
The Dirty Little Secret About Process Optimization in API Manufacturing

Tags: API Manufacturing | Blog | ICH | Optimization | Pharmaceutical Manufacturing

Posted June 21, 2017
Despite all the Rhetoric, Time-Consuming FDA Guidelines Make More Work for CMOs but Safe Products for Consumers

Tags: Blog | FDA | GDUFA | How to select a CMO | ICH | Pharmaceutical Manufacturing | Safety

Posted June 15, 2017
Why the FDA and EMA want you to implement QbD

Tags: Blog | EMA | FDA | ICH | Research and Development | Scale-up | Standard Operating Procedures

Posted June 2, 2017
Outsourcing Your API Manufacturing to Asia?

Tags: Articles | China | ICH | Pharmaceutical Outsourcing

Posted April 5, 2017