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5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensure tha...

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5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensure tha...

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10.As provided in the rules, surrogate marker should be considered as an interim data poin...

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

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(d) records needed to provide evidence that the realisation processes and resulting produc...

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(d) records needed to provide evidence that the realisation processes and resulting produc...

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(e) all personnel shall bear clean body covering appropriate to their duties. Smoking, eat...

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Examined periodically, at least once a year. Records shall be maintained thereof. 6.2.2 Co...

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5.6 Management review 5.6.1 General: Top management shall review the organization's qualit...

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