GXP Inspection & Lab Accreditation
【Update Date:2018-10-17】unit:品質監督管理組
Legal & Regulatory Basis
As stipulated by Article 71, Paragraph 1 of the Pharmaceutical Affairs Act: “Competent health authorities may send their respective officials to inspect the facilities and relevant business operations of pharmaceutical manufacturers and/or dealers and may sample-test the medicaments concerned by issuing a receipt for such purpose, to which the manufacturers or dealers shall not reject without good cause.” For the inspection criteria, Article 3, Paragraph 2 of the Regulations of Medicament Manufacturer Inspection are to be followed: “Their hardware facilities and sanitary conditions must comply with regulations of Part 2 of the Standards for Medicament Factory Establishments and the Factory Management Guidance Act, and shall be subject to inspection by the competent industry authorities and municipal or county (city) competent health authorities.” In addition, as stipulated by Article 92 of the Pharmaceutical Affairs Act, for those in violation of Article 57 Paragraphs 2 through 4, in addition to a fine, the central competent health authority may publicly announce the name of the medicament factory or pharmaceutical firm and order them to make rectification within a prescribed time period, and during the time period for such rectification, may suspend, in whole or in part, their business operations. If rectification is not made within the prescribed time period, the competent health authority may deny approval for extension of the validity of the medicament permit license previously granted, and will not process any other new application for other medicaments from the given factory or firm; in the case of severe violation, the competent health authority may revoke all or part of the medicament manufacture license.
General Requirements
I. The Food and Drug Administration, Ministry of Health and Welfare is responsible for supervising and inspecting GMP manufacturers (manufacturing medicinal products and APIs). Such inspections include new establishments, relocations, expansions, resumption of operations, or addition of new active pharmaceutical ingredients, dosage forms, and processes (packaging and labeling), as well as regular or irregular follow-up inspections.
II. Those to be inspected for medicinal products include firms in the manufacturing, processing of medicinal products; other firms related to the manufacturing, processing or assembling of medicaments, including firms that are approved by the central competent health authority to manufacture medicaments for development; firms that produce drug labeling; and firms related to the packaging of medicaments.
III. For new establishments, relocations, expansions, resumption of operations, or addition of new active pharmaceutical ingredients, dosage forms, processes (packaging and labeling), products for western medicinal products or APIs, if they meet the requirements in Part II and of the Factory Management Act, the municipal or county (county-level city) competent industrial authority is to issue the Factory Registration Certificate or approve registration of alteration as requested, and the municipal or county (county-level city) competent health authority may issue the pharmaceutical dealer permit license for manufacturers or approve the registration of alteration as requested. For domestic manufacturers of medicinal products for which the factory registration documents and the pharmaceutical dealer permit license for manufacturers were obtained in accordance with the requirements indicated in the preceding paragraph, if it is found that the stipulations of the Good Manufacturing Practice are complied with, the competent central health authority will issue a manufacture license certifying GMP compliance for the items that have been inspected.
IV. With domestic manufacturers of western medicinal product that are new establishments, relocations, expansions, or where there is resumption of operations, or addition of new active pharmaceutical ingredients, dosage forms, processes (packaging and labeling), or products, the manufacturer shall pay the fees, complete the Application Form, and enclose supporting documents on successful completion of hardware inspections or the factory registration documents and Site Master File (SMF) to apply for inspections with the competent central health authority. The competent central health authority may inspect the manufacturing facility together with the municipal or county (county-level city) competent health authority.
V. Follow-up inspections are in principle to be conducted once every two years, or prolong one to two years depends on its risk. When it is considered necessary or where there are found to be major hazards for a medicinal product, for cause inspections may be additionally implemented; for such inspections in principle, the parties being inspected without being notified in advance.
Procedure
I. For site inspections, the Food and Drug Administration will send representatives along with representatives from the municipal or county (county-level city) competent health authority and competent industrial authority to verify the manufacturer’s GMP practice. The manufacturers shall cooperate with the inspection by preparing the related Site Master File.
II. The deficiencies found during inspections, medicament manufacturers shall make necessary corrective actions and submit a corrective action report in accordance with inspection reports or other relevant documents within one month.
III. Once corrections are completed for deficiencies, the competent central health authority is to issue a manufacture license certifying GMP compliance for items inspected.
IV. Once the manufacture license is issued, if non-compliance with GMP is found during follow-up inspections by the competent authority, and if no corrective actions are completed by the given deadline or if major hazards or violations are found, such license shall be voided.