Design qualification , Good Manufacturing Practice

EU Guide to Good Manufacturing Practice, Draft revised version of Annexl5 Vahdation master plan Design qualification, instaUation and operational quahfication, non-sterile process vahdation, cleaning vahdation. 

The manufacturer must have an organisation chart People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice. 

Computer hardware needs to be assembled in accordance with good practice and any manufacturer s instructions. Hardware components should be itemized in the Hardware Design and checked as part of the Installation Qualification. 

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