USP 797 refers to Chapter 797 which is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia and applies to all hospital pharmacies. USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations (CSP). It sets the standards that apply to all settings in which sterile preparations of drugs and pharmaceuticals are compounded. The standards apply to all facilities in which CSP’s are prepared, stored, and transported.
ENVIRONMENTAL COMPLIANCE MONITORING
• Viable Bacterial and Fungal Air Monitoring
• Viable Bacterial Surface and Air Monitoring
• Viable Gloved Fingertip Sampling
INSPECTION
• Limited and Comprehensive Surveys of Facilities
REPORTING
• Third party verification of compliance
• Analytical Data Explained by our Experts
• Provides Specific Recommendations to mitigate problem areas based on Analytical Data
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