QA019: SOP FOR PREPARATION, REVIEW, AND CONTROL OF SITE MASTER FILE (SMF)
OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to define the procedure for the preparation, review, approval, distribution, and control of the Site Master File (SMF) in accordance with the requirements of WHO / TRS / EU-GMP Part III and other applicable regulatory guidelines. The SMF provides a detailed overview of the site’s […]