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 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter



This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile 56 Products: Tests for Specified Micro-organisms.

Go back

GMP Conferences by Topics