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FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharm
Origin/Publisher:
FDA / ICH, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073423.pdf
Content:
This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products:
57 Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use.
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