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The manufacturer shall establish arrangements for these processes including, as applicable...

2023-10-17T05:36:04

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(ii) Evidence of the ongoing revalidation of the process should also be provided. Typicall...

2023-09-16T04:49:56

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Design and development validation: Design and development validation shall be performed in...

2023-11-04T06:10:50

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7.3.6 Design and development validation: Design and development validation shall be perfor...

2023-10-13T05:21:41

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6.3 Infrastructure The organisation shall determine, provide and maintain the infrastructu...

2023-10-11T04:46:54

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3.6 Component means any raw material, substance, piece, part, software, firmware, labeling...

2023-10-09T05:41:06

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Proposed instructions for use or electronic instructions for use and labels.] (b) Data to ...

2023-10-05T05:45:10

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PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR MANU...

2023-10-05T05:41:41

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(b) the intended user (lay person or professional); (c) a general description of the princ...

2023-09-16T05:31:26

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