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GUIDANCE DOCUMENT

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 14: Bacterial Endotoxins Test General Chapter October 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0343
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. 

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