Sample SOPs & Diagrams

 
Sample SOPs and Diagrams.jpeg

Sample SOPs & Diagrams

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Material Selection, Qualification, & Approval SOP

  1. Learn which materials can and cannot be used in compounding

  2. Select, qualify, and approve compounding materials

  3. Meet regulatory requirements and quality specifications

 
Good Documentation Practice SOP Compounding Pharmacy

Good Documentation Practice SOP

  1. Learn the basics of good documentation practices (GDP)

  2. Create, approve, review, maintain, correct, verify, and archive documents and records correctly

  3. Minimize staff confusion or regulatory interpretation of events

 

Cleanroom Behavior SOP

  1. Learn the do’s and don’ts of working in a controlled and ISO classified environment

  2. Control contamination in a pharmacy, hospital, or outsourcing facility

  3. Increase sterility assurance of finished compounds and minimize insanitary conditions

Cleanroom Behavior SOP Compounding Pharmacy
 
Beyond Use Date Assignments SOP Compounding Pharmacy

Beyond Use Date Assignments SOP

  1. Assign a beyond use date to a compounded drug preparation

  2. Ensure it will retain its quality and remain sterile (if applicable) throughout the labeled beyond use date

  3. Comply with USP <797> and USP <795>

 

Sample Sterile Facility Layout

  1. Optimize material flow and personnel flow

  2. Align with industry contamination control strategies

  3. Increase sterility assurance of finished compounds and minimize insanitary conditions

Sterile Compounding Facility Design Consultant
 
Can you Compound This?

To Compound or Not: Decision Tree

  1. Decide quickly whether or not to compound a preparation

  2. Comply with FDA Guidance for Compounding

  3. Decrease confusion and prevent inadvertent unauthorized compounding

 
 

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