1、EU cGMP AUDIT CHECKLISTDATE: _CLIENT NAME:_AUDITORS:_ SIT E AD D R E SS:_TY PE o f A CT IVIT Y (cG MP or PA I: _ 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然

2、。6.0 Quality Control 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 ot003(c 3 500t005 (e350 000 2 000calhost:350 000 2 000 3 500 00020 0001077/or ange/cu rrent/c0 2sec106 2.htm - c02tabn ot003C (c http:/lo calhost: 1077/or ange/cu rrent/c0 2sec106 2.htm - c02tabnot003D(c 3 500 00020 000not de fi ne d (f

3、Not defined(fNotes:(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 t

4、ion 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

5、r est” state should be achieved after a short “clean up” period of 1520 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 whenev

6、er 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 itself.(c In ord

7、er to reach the B, C and D air g rades, the numbe r of air changes should be r elated to the size of the room and the equipme ntand personnel pre sent in the room. T he air syste m should be p rovid ed wi th appropria te te rminal filters such as HEP A知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如呼吸輕松自然。 知識如氧氣無處不在,溝通如