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
Title:
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
Origin/Publisher:
FDA / ICH, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073416.pdf
Content:
This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile 56 Products: Microbial Enumeration Tests.