Pharmacy Clean Room USP 797/800 Compliance Checklist [FREE PDF]
This pharmacy clean room usp 797/800 compliance checklist ensures compliance with USP <797> Pharmaceutical Compounding Sterile requirements. Pharmacy Director / Compounding Pharmacists use this checklist to verify regulatory compliance, document findings, and maintain safety and quality standards.
- Industry: Healthcare / Pharmacy
- Frequency: Daily
- Estimated Time: 30-45 minutes
- Role: Pharmacy Director / Compounding Pharmacist
- Total Items: 21
- Compliance: USP <797> Pharmaceutical Compounding Sterile, USP <800> Hazardous Drugs Handling, NIOSH Alert 2004-165 Hazardous Drugs, ASHP Guidelines Hazardous Drug Handling
Documentation and Regulatory Review
Verify required documentation is current and complete.
- Standard Operating Procedures (SOPs) current and accessible?
- All personnel training records current for this activity?
- Required permits, licenses, and registrations current?
- Previous inspection findings reviewed and corrective actions verified?
Safety and Equipment Requirements
Verify safety equipment, PPE, and emergency preparations.
- Required PPE available, clean, and in good condition?
- Emergency equipment (eyewash, shower, extinguisher) accessible?
- Safety Data Sheets (SDS) available for all hazardous materials?
- Emergency contact and response procedures posted?
Operational Compliance Checks
Verify operations comply with regulatory requirements.
- Approved procedures being followed without deviation?
- Equipment qualified/calibrated and within calibration period?
- Environmental monitoring (temp, humidity, pressure) within spec?
- All materials, products, and containers properly labeled?
- Data recorded contemporaneously with no unexplained alterations?
Waste Disposal and Environmental Compliance
Verify proper waste handling and disposal.
- All waste properly labeled with contents and hazard class?
- Waste containers appropriate for waste type and in good condition?
- Waste streams segregated per regulatory requirements?
- Waste disposal records maintained?
Findings and CAPA
Document findings and corrective/preventive actions.
- Any deviations or non-conformances identified?
- CAPA initiated for any findings?
- Photo documentation of findings?
- Inspection findings and recommendations
Related Healthcare Checklists
- Blood Bank Temperature Monitoring Checklist [FREE PDF]
- Pathology Specimen Handling and Chain of Custody Checklist [FREE PDF]
- Dialysis Water Quality Testing Checklist [FREE PDF]
- Neonatal Intensive Care Unit (NICU) Daily Safety Checklist [FREE PDF]
- Behavioral Health Unit Safety Assessment Checklist [FREE PDF]
- Ambulatory Surgery Center Readiness Checklist [FREE PDF]
- Radiation Therapy Machine Daily QA Checklist [FREE PDF]
- Nuclear Medicine Hot Lab Inspection Checklist [FREE PDF]
Related Laboratory Checklists
- Clinical Laboratory Safety Inspection Checklist - FREE Download
- Dental Sterilization Monitoring Checklist [FREE PDF] - FREE Download
- Radiology Equipment Quality Assurance Checklist [FREE PDF] - FREE Download
- Surgical Instrument Count Verification Checklist [FREE PDF] - FREE Download
- Endoscope Reprocessing Validation Checklist [FREE PDF] - FREE Download
- Blood Bank Temperature Monitoring Checklist [FREE PDF] - FREE Download
- Pathology Specimen Handling and Chain of Custody Checklist [FREE PDF] - FREE Download
- Dialysis Water Quality Testing Checklist [FREE PDF] - FREE Download
- Neonatal Intensive Care Unit (NICU) Daily Safety Checklist [FREE PDF] - FREE Download
- Behavioral Health Unit Safety Assessment Checklist [FREE PDF] - FREE Download
Why Use This Pharmacy Clean Room USP 797/800 Compliance Checklist [FREE PDF]?
This pharmacy clean room usp 797/800 compliance checklist [free pdf] helps healthcare / pharmacy teams maintain compliance and operational excellence. Designed for pharmacy director / compounding pharmacist professionals, this checklist covers 21 critical inspection points across 5 sections. Recommended frequency: daily.
Ensures compliance with USP <797> Pharmaceutical Compounding Sterile, USP <800> Hazardous Drugs Handling, NIOSH Alert 2004-165 Hazardous Drugs, ASHP Guidelines Hazardous Drug Handling. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmacy Clean Room USP 797/800 Compliance Checklist [FREE PDF] cover?
This checklist covers 21 inspection items across 5 sections: Documentation and Regulatory Review, Safety and Equipment Requirements, Operational Compliance Checks, Waste Disposal and Environmental Compliance, Findings and CAPA. It is designed for healthcare / pharmacy operations and compliance.
How often should this checklist be completed?
This checklist should be completed daily. Each completion takes approximately 30-45 minutes.
Who should use this Pharmacy Clean Room USP 797/800 Compliance Checklist [FREE PDF]?
This checklist is designed for Pharmacy Director / Compounding Pharmacist professionals in the healthcare / pharmacy 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.