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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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Design and development review: At suitable stages, systematic reviews of design and develo...

2023-11-04T05:19:45

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As part of design and development validation, the manufacturer shall perform clinical eval...

2023-11-04T06:17:57

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Design and development verification: Verification shall be performed in accordance with pl...

2023-11-04T06:09:21

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Records of validation shall be maintained. 7.5.2.2 Particular requirements for sterile med...

2023-10-17T05:39:45

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7.5.2 The manufacturer shall validate any processes for production and service provision w...

2023-10-19T07:17:46

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POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be des...

2023-10-28T05:47:16

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15.However, detailed guidance documents should be prepared providing the requirements and ...

2023-10-28T05:49:46

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POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be des...

2023-10-26T11:09:31

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