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

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Further CDSCO along with state regulators, is jointly responsible for grant of licenses of...

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5.6.2 Review input: The input to management review shall include information on— (a) resul...

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4.2.3 Control of documents : Documents required by the quality management system shall be ...

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Data may be recorded by electronic data processing systems or other reliable means, but do...

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Proposed instructions for use or electronic instructions for use and labels.] (b) Data to ...

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3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer a...

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

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

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