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Validation Process : ((All attributes and parameters should be evaluated…
Validation Process :
All attributes and parameters should be evaluated in terms of their roles in the process and impact o the product or in-process material
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Quality cannot be adequately assured merely by in-process and finished-product inspection or testing
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Quality, safety, and efficacy
Why
To collect and analyze product and process data that relate to product quality that must be established
The information collected verifies the quality attributes that are being appropriately controlled throughout the process
Expectation
Good process design and development should anticipate significant sources of variability and establish appropriate detection,
continued monitoring and sampling of process parameters and quality attributes at the level established during the process qualification stage
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Maintenance of the facility, utilities, and equipment is another important aspect of ensuring that a process remains in control
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THE COLLECTION AND EVALUATION OF DATA, FROM THE DESIGN STAGE THROUGH COMMERCIAL PRODUCTION , WHICH ESTABLISHES SCIENTIFIC EVIDENCE THAT A PROCESS IS CAPABLE OF CONSISTENTLY DELIVERING QUALITY PRODUCT.
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