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.