ISPE would like your help in providing comments to the US FDA on the topic of continuous manufacturing. ISPE and its members have a wealth of experience in this area and we believe our comments can have a positive influence on the regulatory landscape moving forward.
ISPE has revitalized the team that was formed after the ISPE 2016 Continuous Manufacturing Conference to lead the commenting efforts. The approach that we would like to take in the ISPE response is to capture the aspects that FDA should consider for future FDA or International Guidance. Click here to view a template and example recommendation and click here to view the details of the FDA solicitation.
If you are interested in providing comments for consideration in preparation of the response, please add them to the template and email it to firstname.lastname@example.org by Thursday, 31 August. ISPE thanks you in advance for your contribution.