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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Q3C: Appendix 5  Food and Drug Administration (FDA) Final
Q4B Annex 10: Polyacrylamide Gel Electrophoresis General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 5: Disintegration Test General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 6: Uniformity of Dosage Units General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 7 (R2): Dissolution Test General Chapter  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.