The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Eudralex Volume 3 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (draft)

Origin/Publisher:

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Document Type:
Guideline
Content:
This guideline addresses the data requirements for the validation of biotech manufacturing processes for submission of a marketing authorisation application or variation.

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