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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...