Change control

The documented process for proposing, evaluating, approving and recording changes to processes, equipment, materials, procedures or test methods, with an assessment of their impact on quality. Japan's GMP Ministerial Ordinance requires written change control procedures at manufacturing sites. The Japan-specific step is regulatory. A change that touches what the marketing approval says needs either a partial change application, approved before the change, or a minor change notification filed within 30 days, and the MAH files it, not the site. Since 2021 the ordinance has also required sites to comply with the approved matters explicitly. Put a check against the Japanese approval text into your change control form for every product you supply to Japan.