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
COMPOUNDING NONSTERILE PREPARATIONS©

and

USP 797 - GAP ANALYSIS SURVEY
COMPOUNDING STERILE PREPARATIONS®

 
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.