The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter



This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile 56 Products: Microbial Enumeration Tests.

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