Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter

Regulatory Resource: Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) on 5 June 2008.
This annex is the result of the Q4B process for Test for Particulate Contamination: Sub-Visible Particles.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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