simpl.
로그인
의료기관 컴플라이언스 14개 항목

Pharmacy Sterile Compounding USP <797>/<800> Audit

이 체크리스트는 영어로 제공됩니다.

Audit of pharmacy sterile and hazardous drug compounding operations against USP <797> and <800> for facilities, engineering controls, and personnel practices.

USP <797>USP <800>CMS 42 CFR 482.25

무료 PDF 또는 Word · 이메일을 입력하면 다운로드할 수 있습니다.

Facilities & Engineering Controls

  • Is sterile compounding performed in an ISO Class 5 primary engineering control (PEC) within an ISO Class 7 buffer area? *
  • Is certification of PECs, SECs, and cleanrooms performed at least every 6 months? *
  • Are pressure differentials between the buffer, ante-area, and general pharmacy monitored and documented? *
  • Is viable and non-viable air/surface environmental sampling performed at the required frequency? *

Personnel Training & Garbing

  • Do compounding personnel complete initial and periodic competency including gloved fingertip and media-fill testing? *
  • Is hand hygiene and garbing performed in the correct order and re-donned when exiting the ante-area? *
  • Is aseptic technique observed and documented during compounding? *

Compounding & Beyond-Use Dating

  • Are beyond-use dates (BUDs) assigned based on category, sterility testing, and storage conditions? *
  • Are master formulation and compounding records maintained for compounded sterile preparations? *
  • Is a final visual inspection and verification performed before release of each preparation? *

Hazardous Drug Handling (USP <800>)

  • Is an assessment of risk maintained and hazardous drugs on the NIOSH list identified? *
  • Are hazardous drugs compounded in a containment primary engineering control within a negative-pressure C-SEC? *
  • Is hazardous drug receipt, storage, and spill response managed with appropriate PPE and a spill kit? *
  • Is environmental wipe sampling for hazardous drug surface contamination performed periodically?

Pharmacy Sterile Compounding USP <797>/<800> Audit 체크리스트 전체 다운로드

인쇄하기 좋은 PDF 또는 편집 가능한 Word 문서로 무료로 받으세요.