This draft guidance, when finalized, will represent the current thinking of the US Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Since the ICH Q11 guideline was finalized, worldwide experience with the implementation of the recommendations on the development and manufacture of drug substances.
This Question and Answer (Q & A) document is intended to provide additional guidance and support for the discussion of the subject and for the purposes of the application. The focus of the Q & A document is on the chemical entity drug substances.