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PDA task force experts for Annex 1 implementation provide isight for contract organizations, ATMP producers and sterile manufacturers on compliance with Annex 1 requirements and suggestions for delayed implementation dates.

The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article...

The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article...

The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While...

While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a...

The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is...

In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have...

The landscape of risk management between biopharma companies and their CDMOs looks nothing like those where direct oversight is the operating...

When the pandemic hit, the tools normally available to a risk facilitator during a working session were gone. This article presents some of the...

When the pandemic hit, the tools normally available to a risk facilitator during a working session were gone. This article presents some of the...