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

2023-10-25T05:12:05

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7.53.3 Status identification The manufacturer shall identify the product status with respe...

2023-10-17T05:41:39

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

2023-10-28T05:39:00

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After the NDA is accepted the various section of the application should undergo concurrent...

2023-10-26T11:13:04

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Such discussion to help the reviewers becomes acquainted with the information to be includ...

2023-10-26T11:10:29

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BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmet...

2023-10-26T05:38:50

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5. Clear policy on regulatory requirements, system and procedures is critical for efficien...

2023-10-26T05:37:00

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

2023-10-26T05:36:08

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