Pharmacy Compounding USP 797

This Pharmacy Compounding USP 797 ensures systematic verification and compliance with USP 797, USP 800 requirements. Complete all sections to maintain safety, quality, and regulatory compliance. Document all findings and initiate corrective actions as required.

  • Industry: Healthcare
  • Frequency: Daily
  • Estimated Time: 20-30 minutes
  • Role: Pharmacist
  • Total Items: 37
  • Compliance: USP 797, USP 800

Pre-Inspection Verification

Initial setup and documentation review before inspection.

  • Previous inspection records reviewed?
  • Inspection scope and areas defined?
  • Required PPE available and worn?
  • Inspection tools and forms ready?

Regulatory Compliance Verification

Verify compliance with applicable standards and regulations.

  • Required permits current and posted?
  • Training records current for personnel?
  • Written procedures available at point of use?
  • Required documentation maintained?
  • Required signage properly displayed?

Physical Inspection

Visual and physical inspection of equipment and areas.

  • Overall condition acceptable?
  • No visible damage or defects?
  • Safety guards and barriers in place?
  • Housekeeping standards maintained?
  • Emergency equipment accessible?
  • Exits and egress routes clear?

Operational Verification

Functional testing and operational verification.

  • Equipment operating properly?
  • Safety devices and interlocks functional?
  • Monitoring equipment calibrated?
  • No unusual conditions observed?

Findings and Corrective Actions

Document findings and assign corrective actions.

  • All deficiencies documented?
  • Corrective actions assigned with due dates?
  • Any immediate hazards addressed?
  • Photos of significant findings attached?
  • Overall Inspection Rating
  • Additional Notes and Recommendations
  • Emergency exits unobstructed and properly marked?
  • First aid supplies stocked and accessible?
  • Fire extinguisher accessible and inspection current?
  • All identified hazards documented and controlled?
  • ...and 4 more items

Infection Prevention & Control

Infection control per CDC/Joint Commission

  • Hand hygiene compliance observed?
  • Isolation precautions followed correctly?
  • Sharps containers not overfilled?
  • Appropriate PPE available and used?

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Why Use This Pharmacy Compounding USP 797?

This pharmacy compounding usp 797 helps healthcare teams maintain compliance and operational excellence. Designed for pharmacist professionals, this checklist covers 37 critical inspection points across 6 sections. Recommended frequency: daily.

Ensures compliance with USP 797, USP 800. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Pharmacy Compounding USP 797 cover?

This checklist covers 37 inspection items across 6 sections: Pre-Inspection Verification, Regulatory Compliance Verification, Physical Inspection, Operational Verification, Findings and Corrective Actions, Infection Prevention & Control. It is designed for healthcare operations and compliance.

How often should this checklist be completed?

This checklist should be completed daily. Each completion takes approximately 20-30 minutes.

Who should use this Pharmacy Compounding USP 797?

This checklist is designed for Pharmacist professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.

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