ICH Q9 Revision 1: Updates to Enhance Quality Risk Management in the Pharmaceutical Industry and a Pathway to a Robust Contamination Control Strategy
Blog Post

ICH Q9 Revision 1: Updates to Enhance Quality Risk Management in the Pharmaceutical Industry and a Pathway to a Robust Contamination Control Strategy

Originally issued in 2005, ICH Q9 laid down principles and examples of tools for QRM that can be applied throughout the product lifecycle. It was...

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State of Validation
Blog Post

State of Validation

CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey.  The survey targets current professionals in a...

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Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline
Blog Post

Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline

To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality...

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