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Process Validation Report Template sample

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TEM-295 Issue date Process Validation Interim / Final Report (Reference: SOP _____) Page 1 of 21 [Enter Product Title, Number & Strength] PRODUCT CODE: WRITTEN BY: REVIEWED BY: Name: Signature: Position: Date: Qualification Status Qualification of [enter raw material item description, item code] as per protocol [enter protocol no] has been completed for the following: [enter product name, code and lot no] All deviations and additional protocol results for the batch are documented in this interim Report .

TEM-295 Issue date Process Validation Interim / Final Report (Reference: SOP _____) Page 19 of 21 The Control limits generated for the process above is based on the combined 30 sample data from each batch. To visualise the between batch variation the 30 data points from each batch should have separate control limits to show uniformity.

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