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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

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Design and development validation: Design and development validation shall be performed in...

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7.3.6 Design and development validation: Design and development validation shall be perfor...

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

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2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationale fo...

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18.0 Shipping stability: This section should provide information on shipping stability stu...

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17.0 In use stability: This section should provide information on in use stability studies...

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9.2 Reproducibility: This section should include reproducibility estimates and information...

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