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18.0 Shipping stability: This section should provide information on shipping stability stu...

2023-10-05T05:31:56

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(a) the manufacturer shall establish documented requirements for health, cleanliness and c...

2023-10-11T04:52:42

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such as: (a) substances used for patient treatment (e.g. therapeutic drugs, anticoagulan...

2023-10-04T04:30:37

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8.0 Specimen type: (a) This section should describe the different specimen types that can ...

2023-10-03T05:23:55

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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

2023-10-17T05:26:07

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

2023-10-05T05:30:04

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

2023-10-04T04:43:45

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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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Note: Configuration management is a means by which identification and traceability can be...

2023-10-17T05:40:48

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