Jim Agalloco, Russ Madsen and Jim Akers developed a comprehensive set of comments to the draft revision of Annex 1. The authors believe it is essential that the EMA receive comments that outline the difficulties that the draft presents. Their more than 170 comments cover the entire document and detail its many shortcomings. Feel free to download and reuse them in your own comment submission on EMA’s December 2017 revision.
Keywords: Submission of comments on Revision of ‘Annex 1: Manufacture of Sterile Medicinal Products’
The content you requested is only available for registered users. Please, register to download the file. It's fast and free. Register here. If you are a registered user enter your e-mail address and password to log in.