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USP 795 - GAP ANALYSIS SURVEY USP 797 - GAP ANALYSIS SURVEY |
| Do you meet the new standards of practice? IJPC now has two tools that allow you to survey and assess your compliance with the USP 795 and USP 797. IJPC's GAP Analysis enables you to do a self-assessment with various components of USP 795 and USP 797. After the completion of the assessment, if there are "no" answers, we encourage you to obtain a copy of USP 795 and/or USP 797 from www.usp.org. |
| An outline of these survey documents is provided below: |
| I. USP 795 - GAP ANALYSIS SURVEY COMPOUNDING NONSTERILE PREPARATIONS© |
| Introduction |
| Responsibility of the Compounder |
| Compounding Environment Facilities Equipment |
| Stability of Compounded Preparations Primary Packaging Sterility Stability Criteria and Beyond-Use Dating For Nonaqueous Liquids and Solid Formulations For Water-Containing Formulations (prepared from ingredients in solid form) For All Other Formulations Beyond-Use Labeling |
| Definitions |
| Ingredient Selection Sources Compounding Non-drug Requirements |
| Checklist for Acceptable Strength, Quality and Purity |
| Compounded Preparations Capsules, Powders, Lozenges and Tablets Emulsions, Solutions, and Suspensions Suppositories Creams, Topical Gels, Ointments, and Pastes |
| Compounding Process |
| Compounding Records and Documents Formulation Record Compounding Record MSDS File |
| Quality Control |
| Verification |
| Patient Counseling |
| II. USP 797 - GAP ANALYSIS SURVEY COMPOUNDING STERILE PREPARATIONS® |
| Introduction |
| Responsibility of Compounding Personnel |
| CSP Microbial Contamination Risk Levels |
| Patient Monitoring and Adverse Events Reporting |
| Verification of Compounding Accuracy and Sterilization |
| Personnel Training and Evaluation in Aseptic Manipulation Skills |
| Environmental Quality and Control |
| Processing |
| Verification of Automated Compounding Devices for Parenteral Nutrition Compounding |
| Finished Preparation Release Checks and Tests |
| Storage and Beyond-Use Dating |
| Maintaining Product Quality and Control after the CSP Leaves the Pharmacy |
| Patient or Caregiver Training |
| The Quality Assurance Program |
| Definitions: CSPs include any of the following: 1. Preparations prepared according to the manufacturer's labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination. 2. Preparations containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration. 3. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that possess either of the above two characteristics, and which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalations, injections, powders for injection, irrigations, metered sprays and ophthalmic and otic preparations. |