Guideline

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Note for Guidance on Process Validation
Short Title:	CPMP QWP 848/96
Internet:	http://www.ema.europa.eu/pdfs/human/qwp/084896en.pdf
Origin/Publisher:	European Agency for the Evaluation of Medicinal Products
Content:	This note for guidance is intended to demonstrate and standardise the data that should be routinely included in the marketing authorisation dossier and distinguish them from those validation data which more properly fall under the remit of GMP Inspection.
Document Type:	CPMP Note for Guidance