Sample SOPs & Diagrams
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Material Selection, Qualification, & Approval SOP
Learn which materials can and cannot be used in compounding
Select, qualify, and approve compounding materials
Meet regulatory requirements and quality specifications
Good Documentation Practice SOP
Learn the basics of good documentation practices (GDP)
Create, approve, review, maintain, correct, verify, and archive documents and records correctly
Minimize staff confusion or regulatory interpretation of events
Cleanroom Behavior SOP
Learn the do’s and don’ts of working in a controlled and ISO classified environment
Control contamination in a pharmacy, hospital, or outsourcing facility
Increase sterility assurance of finished compounds and minimize insanitary conditions
Beyond Use Date Assignments SOP
Assign a beyond use date to a compounded drug preparation
Ensure it will retain its quality and remain sterile (if applicable) throughout the labeled beyond use date
Comply with USP <797> and USP <795>
Sample Sterile Facility Layout
Optimize material flow and personnel flow
Align with industry contamination control strategies
Increase sterility assurance of finished compounds and minimize insanitary conditions
To Compound or Not: Decision Tree
Decide quickly whether or not to compound a preparation
Comply with FDA Guidance for Compounding
Decrease confusion and prevent inadvertent unauthorized compounding
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