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Clinical IQ, LLC is the main destination for USP <797> compliance solutions in the pharmaceutical community.  Facilities design services are provided in partnership with Jim Wagner of Micro-Clean, Inc.  Jim has been an industry leader in the field of HEPA filtration and environmental control for over 25 years. He is an elected member of the United States Pharmacopoeia Engineering Controls Committee (2005-2010).

The facilities design solutions start with a comprehensive on-site USP 797 Gap Analysis to determine practice areas that require attention and result in a report describing corrective actions as well as additional feedback (sample report) on all USP <797> compliance issues.  These compliance issues include, but are not limited to: 

  • Compounding personnel responsibilities
  • 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
You get the invaluable technical experience of the “USP 797 Gap Analysis and Risk Assessment Tool” author and a team of experts who have been deeply involved with the development and updates of the USP <797> document and the pharmaceutical and aseptic processing communities.

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