PHARMACEUTICAL COMPOUNDING STERILE PREPARATIONS SOLUTIONS

Do you know where to turn to for  your USP 797 compliance solutions?

The solutions consist of a comprehensive on-site USP 797 Gap Analysis to determine areas requiring attention and a report describing corrective actions as well as positive feedback on all USP 797 compliance issues such as:

  • Responsibilities of all compounding personnel
  • Basis for the classification of a CSP (Compounding Sterile Preparations) into low-, medium-, or high-risk level, with examples of CSPs and their quality assurance practices in each of these risk levels
  • Verification of compounding accuracy and sterilization
  • Personnel training and evaluation in aseptic manipulation skills, including representative sterile microbial culture medium transfer and fill challenges
  • Environmental quality and control during the processing of Compounding Sterile Preparations
  • Equipment used in the preparation of Compounding Sterile Preparations
  • 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 CSPs leave the compounding facility, including education and training of personnel
  • Packing, handling, storage, and transport of Compounding Sterile Preparations
  • Patient or caregiver training
  • Patient monitoring and adverse events reporting
  • A quality assurance program for Compounding Sterile Preparations