simpl.
Entrar
eQMS para Ciências da Vida 19 itens

Pharmaceutical Water System Monitoring & Control Checklist (USP <1231>)

Este checklist está em inglês.

Assesses design, monitoring, and control of pharmaceutical water systems producing Purified Water and Water for Injection. Use for periodic system review and monitoring program verification.

USP <1231>USP <645>USP <643>21 CFR 211.113

PDF ou Word gratuito · informe seu e-mail para baixar.

System Design and Materials

  • Is the water system designed to minimize dead legs and promote continuous circulation/turbulent flow? *
  • Are wetted materials of construction compatible and documented (e.g., 316L stainless steel, appropriate polymers)? *
  • Is the distribution loop maintained under conditions that control biofilm (e.g., hot circulation or continuous ozonation)? *
  • Are points of use fitted with appropriate sampling and drainage design? *

Chemical Quality Monitoring

  • Is conductivity monitored and within the stage limits of the compendial method? *
  • Is Total Organic Carbon (TOC) monitored and within limits? *
  • Record the most recent point-of-use conductivity result.
  • Are online instruments calibrated and their calibration status current? *

Microbial and Endotoxin Control

  • Are microbial action and alert levels established and monitored for each water grade? *
  • For Water for Injection, is bacterial endotoxin monitored against the NMT 0.25 EU/mL limit? *
  • Are sampling frequency and locations defined in a written monitoring program? *
  • Are excursions beyond alert/action levels investigated and trended? *

Sanitization and Maintenance

  • Is the system sanitized (thermal, chemical, or ozone) at a validated, documented frequency? *
  • Are filters, UV lamps, and RO/EDI units maintained and replaced per schedule? *
  • Record the date of the last full-loop sanitization.
  • Is preventive maintenance documented in equipment logs? *

Data Review and Qualification Status

  • Is the system's qualification (Phases 1, 2, 3) complete and periodic requalification current? *
  • Are trend reviews of chemical and microbial data performed at a defined frequency? *
  • Is water quality confirmed suitable for its intended manufacturing use? *

Baixe o checklist Pharmaceutical Water System Monitoring & Control Checklist (USP <1231>) completo

Receba gratuitamente em PDF limpo e pronto para impressão ou em documento Word editável.