欧盟GMP现场检查条款_图文.doc

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EU cGMP AUDIT CHECKLIST DATE: ____________CLIENT NAME:____________________________AUDITORS:__________________________ SIT E AD D R E SS:__________________________________________________________ TY PE o f A CT IVIT Y (cG MP or PA I: ______________________________________________ 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 6.0 Quality Control 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 ot003 (c 3 500t005 (e350 000 2 000 http://lo calhost:350 000 2 000 3 500 00020 000 1077/or ange/cu rrent/c0 2sec106 2.htm - c02tabn ot003C (c http://lo calhost: 1077/or ange/cu rrent/c0 2sec106 2.htm - c02tabn ot003D (c 3 500 00020 000not de fi ne d (f Not defined (f Notes: (a Particle measur emen t base d on the use of a di scre te airborne particle counter to measure the concentra tion of particles at de signated sizes equal to o r grea ter than the thre shold stated. A continuous mea sure ment system should be use d for monitoring th e concentra tion of particles in the g rade A zone, and is r ecommende d for the surrounding g rade B areas. For routine t esting the to tal sa mple volu me should not be le ss than 1 m3 for g rade A and B a reas and p referably also in grade C areas. (b The partic ulate conditions given in the table for the “at r est” state should be achieved after a short “clean up” period of 15– 20 minutes (guidance value in an unmanned state aft er completion of operations. The particulate conditions for grade A “in operation” giv en in the table should be maintained in the zone immediat ely surrounding the product whenever the product or open container is exposed to the environment. It is accept ed that it may not always b e possible to d emonstrate conformity with particulate standards at the point of fill when filling is in progress, due to the generation of particles or droplets from the product i

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