Eudralex Volume 3 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS
Title:
Eudralex Volume 3 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Note for Guidance
Content:
The objective of this document is to provide principles for assessing the comparability of
biotechnological/biological products before and after changes are made in the
manufacturing process for the drug substance or drug product. Therefore, this guideline
is intended to assist in the collection of relevant technical information which serves as
evidence that the manufacturing process changes will not have an adverse impact on the
quality, safety and efficacy of the drug product. The document does not prescribe any
particular analytical, nonclinical or clinical strategy. The main emphasis of the document
is on quality aspects.