Contract manufacturing

Manufacturing carried out by an outside company, a CMO or CDMO, on behalf of the product owner. In Japan the marketing authorization holder can outsource manufacturing but keeps responsibility for quality, and it must supervise its manufacturers under the GQP Ordinance. A contract site outside Japan that makes a drug or drug substance for the Japanese market needs Accreditation of Foreign Manufacturers under PMD Act Article 13-3, valid for five years, and PMDA can inspect it on-site or on documents. Accreditation is granted per site and category, so a CDMO accredited for one type of manufacturing is not automatically covered for another.