欧盟GMP对隔离操作要求.pptVIP

Monitoring 监控 7.4.12 The range of parameters and events that should be monitored to assure the delivery of the validated process should be defined. 应对参数范围和操作监控，以确保执行经验证过的工艺。 Key concerns – how are the parameters and events checked for batch release purposes 关键问题 – 如何检查参数和操作，以放行产品 Design aspects 设计方面 7.5.2 The control of leaks between the isolator and surrounding room and between different parts of the isolator system as necessary, should be assured as far as possible. As a guide a minimum of 10 Pascal positive differential air pressure should be maintained to protect against unforeseen circumstances. The maintenance of positive pressure should be monitored and fitted with an alarm. 应尽量保证控制隔离器和周围环境以及隔离器系统的各部件之间的泄漏。为防止意外事件，建议正压差最少保持在10帕。正压应监控并安装警报装置。 Design aspects 设计方面 Note : Some agencies require 50 to 60Pa ?P 注意：有一些监管机构要求压差保持在 50 - 60Pa (?P) Design aspects 设计方面 7.5.4 Transfer of material out of the isolator should not compromise the critical zone. 将物料从隔离器中转运出来时，不应污染关键区域 Design aspects 设计方面 7.5.6.1 The design of the isolator system should include consideration of air change rate, the use of laminar, unidirectional or turbulent airflow, the application of aseptic technique and risk of error due to human fallibility. The rationale for the decisions taken should be documented. 隔离系统的设计应考虑到换气率、层流、单向流或涡流、无菌技术的应用以及人为失误带来的风险。所作各种决定的理由应有相应记录。 Specific points of inspection interest检查过程主要关注点 Environmental monitoring 环境监控 Consistent with Annex 1 与附录1一致 Danger of introduction of contaminated media 引入受污染的介质的风险 Danger of false negatives due to residual sporicidal agent 残余杀孢子剂造成假阴性结果的风险 Use of aseptic processing 无菌工艺的应用 Specific points of inspection interest检查过程主要关注点 Transfer of materials for sterility testing into sterility test isolator; no ingress of sterilant 将物料转运至无菌检测隔离器进行无菌检查；不得含杀菌剂 Change out of gloves in operation 在操作过程中更换手套 Classification of area outside isolators – if Grade C then no outdoor clothing worn underneat