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picture1_2022 Ncpa Usp Presentation


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 86x       Filetype PDF       File size 0.82 MB       Source: ncpa.org


File: 2022 Ncpa Usp Presentation
Revisions to USP Compounding Standards ⟨795⟩ and ⟨797⟩ Brian Serumaga, PhD., November 2022 Approach to Revisions after the Appeals Stakeholder Engagement – Reviewed feedback, including PF public comments ...

icon picture PDF Filetype PDF | Posted on 16 Jan 2023 | 2 years ago
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...Revisions to usp compounding standards and brian serumaga phd november approach after the appeals stakeholder engagement reviewed feedback including pf public comments issues raised in held semi structured interviews may roundtable session july open forums september identified key discussion topics as a framework also had general considerations throughout review process scientifically robust risk based assigning buds physical chemical stability sterility assurance operational implications balancing need for patient access cost effective compounded preparations with rigorous quality on regulatory oversight enforcement overview of revised chapter pharmaceutical nonsterile outline introduction scope sops personnel training evaluation control personal hygiene garbing cnsp packaging transporting buildings facilities documentation cleaning sanitizing glossary equipment components master formulation records release inspections testing labeling establishing beyond use dates...
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