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Explanation : Interference studies involve adding the potential interferent to the sample...

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Recall Action Commencement Date: The date the recall strategy and communication was agreed...

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Best Regulatory Affair in Delhi NCR. iv Recall Action Level: The level to which the recall...

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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

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2.0 Device description and product specification, including variants and accessories 2.1 T...

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2.0 Device description and product specification, including variants and accessories 2.1 T...

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3. Premises and Facilities: (i) layout of premises with indication of scale; (ii) nature o...

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

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11.0 Analytical specificity: (i) This section should describe interference and cross react...

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