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4. When there is a change in main equipment or adjust of API supplier that may change the degradation profile in the API.Then the PV can include validation around Mix stage with 3 batches of common Mix and validation of subsequent unit processes like compression, coating etcetera. with 3 batches each energy.Validation is among A very powerful ideas

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Quantity of personal degraded substances located, complete volume of degraded substances found, assay and some of assay and degraded substances.Unless of course specified in this Agreement, all Specific or implied situations, representations and warranties, including any implied guarantee of merchantability, Physical fitness for a specific intent o