Question: Retrospective Validation is: When there is a manufacturing process change which may affect the product's characteristics For new product Documenting all the historical information for
Retrospective Validation is:
| When there is a manufacturing process change which may affect the product's characteristics
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| For new product
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| Documenting all the historical information for existing product and using that data to support the position that the process under control |
Cleaning validation is:
| When there is a manufacturing process change which may affect the product's characteristics
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| For new product
| ||
| Procedure will reproducibly remove the previous cleaning agents used in the equipment below the scientifically set maximum allowable carryover level
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| Documenting all the historical information for existing product and using that data to support the position that the process under control
|
Is the highest tested dose at which no adverse effect is observed.
| NOAEL
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| ADE
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| HBELs
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| PDE
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| MACO
|
When A daily dose of a substance below which no adverse effects are anticipated, by any route, even if exposure occurs for a lifetime.
| NOAEL
| ||
| ADE
| ||
| HBELs
| ||
| PDE
| ||
| MACO
|
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