Contamination Control Strategy(CCS)-污染控制策略(CCS) 51次、Sterile Product-无菌产品 48次、Isolator-隔离器 48次、Operator-操作员 35次、Pyrogen-热原 32次、Disinfection-消毒 31次、Endotoxin-内毒素 29次、Cleaning-清洁 29次、...
Contamination Control Strategy(CCS)-污染控制策略(CCS) 51次、Sterile Product-无菌产品 48次、Isolator-隔离器 48次、Operator-操作员 35次、Pyrogen-热原 32次、Disinfection-消毒 31次、Endotoxin-内毒素 29次、Cleaning-清洁 29次、Restricted Access Barrier System(RABS)-限制进入屏障系统...
行动限(Action limit)——所建立的相关指标(例如,微生物限度或悬浮粒子限度),当超过此限度时,应触发适当的调查和基于此调查的纠正措施。 Alert level —— An established relevant measure (e.g. microbial, or airborne particle levels) giving early warning of potential drift from normal operating conditions ...
ii. The definition of “in operation” state is the condition where the installation of the cleanroom is complete, the HVAC system fully operational, equipment installed and functioning in the manufacturer’s defined operating mode with the maximum number of personnel present performing or simulating ...
An effective management system Application of HACCP (hazard analysis and critical control points) principles. Elements such as traceability, monitoring, program with basic requirements, chain approach and the early warning systems ADDITIONAL SERVICES HACCP Certification Mark FSSC 22000 Ce...
(for material and personnel), the entry and exit doors should not be opened simultaneously. For airlocks leading to the grade A and grade B areas, an interlocking system should be used. For airlocks leading to grade C and D areas, a visual and/or audible warning system should be ...
Elemente wie die Rückverfolgbarkeit, die Überwachung, das Programm mit Grundbedingungen, der produktionsstufenübegreifenden Zusammenarbeit und das EWS (Early Warning System) Was bedeutet „Zertifizierung“ für GMP+ durch die TÜV SÜD Management Service GmbH? Wie wird geprüft? Was k...
However, GMP itself is not a QA system, but instead only provides specific instructions for production processes and for controlling the products that are manufactured. GMP must be integrated in an existing, functional Quality Management System (QMS). ...
For airlocks leading to grade A zone and grade B areas, an interlocking system should usually be used. For airlocks leading to grade C and D cleanrooms, at least a visual and/or audible warning system should be operated as a minimum. Where required to maintain zone segregation, a time ...
Become part of a global operating feed assurance system (the GMP+ certificate is internationally accepted by approximately 17,200 companies certified in 72 countries); Are accepted by other schemes; Have access to supporting information (fact sheets, risk assessments, newsletters, Early Warning messages...