IJPC <795> and <797> GAP Analysis Survey
Use these documents to conduct preliminary surveys for compliance to United States Pharmacopeia Chapter <795> - Pharmaceutical Compounding—Nonsterile Preparations and <797> - Pharmaceutical Compounding—Sterile Preparations
Click to download the USP <795> Pharmaceutical Compounding—Nonsterile Preparations survey document (Adobe .PDF, 647 Kb).
Click to download the USP <797> Pharmaceutical Compounding—Sterile Preparations survey document (Adobe .PDF, 426 Kb).
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©|
|Responsibility of the Compounder|
|Stability of Compounded Preparations
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
Compounding Non-drug Requirements
|Checklist for Acceptable Strength, Quality and Purity|
Capsules, Powders, Lozenges and Tablets
Emulsions, Solutions, and Suspensions
Creams, Topical Gels, Ointments, and Pastes
|Compounding Records and Documents
|II. USP 797 - GAP ANALYSIS SURVEY COMPOUNDING STERILE PREPARATIONS®|
|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|
|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|
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.