"On-site Inspection Guidelines for Material Management of Drug Marketing Authorization Holders/Drug Manufacturing Enterprises" is based on the key points and risk points of material management of the holder/drug manufacturing enterprise, from material supplier management, material release, management of unqualified materials, and special management Provide prompts on materials and other aspects, form inspection guidelines, and provide inspection technical guidance for inspectors to carry out on-site inspections of materials management of holders/drug manufacturers.
T/JXYXH 0004-2023 history
2023T/JXYXH 0004-2023 Site inspection guide for material management of marketing authorization holder/drug manufacturer