Documentation is An important Component of the standard assurance system and, as such, must be connected with all aspects of GMP. Its purpose is always to define the specifications for all components and the strategy of manufacture and Manage, in order that all personnel worried about manufacture have the information necessary to choose whether or
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Just after draining, this valve (the 2nd off with the system) is closed. If on the following day or start-up on the operation the main valve off on the circulating system is opened, then the non-sterile air remaining in the pipe just after drainage would contaminate the system. The solution is usually to pro-vide for operational methods that delive
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