GXP Inspection & Lab Accreditation
【Update Date:2018-10-16】unit:品質監督管理組
I. Purpose The GMP assessment process for medicinal products is regulated as stipulated by the Pharmaceutical Affairs Act and the Regulations of Medicament Manufacturer Inspection, in order to reinforce the supervision and management of quality of medicinal products.
II. Applicable to
1. Firms in the manufacturing, processing of pharmaceutical products
2. 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. Scope of Application
1. GMP assessment for domestic pharmaceutical manufacturers of medicinal products (including those manufacturing preparations, medicinal gases, APIs, pilot facilities, and logistics factories that also deal with sub-packaging) that are establishment, relocation, expansion, resumption of operations, addition of new dosage forms, APIs, processes (packaging and labeling).
2. Follow-up inspections for facilities that manufacture medicinal preparations
IV. Legal Basis
Articles 57 and 71 of the Pharmaceutical Affairs Act.
V. Inspection Criteria
Hardware: Part II of the Standards for Medicament Factory Establishments, and the Factory Management Act
Software: Part II of the Pharmaceutical Good Manufacturing Practice Regulations
VI. Inspection Unit
Competent central health authority (Food and Drug Administration); municipal or county (county-level city) competent health authorities
VII. Procedure:
(1) When applying for GMP assessment upon new establishment, relocation, expansion, resumption of operation, addition of new dosage forms, APIs, processes (packaging and labeling), and pharmaceutical manufacturers shall complete the Domestic Pharmaceutical Manufacturer GMP Assessment Application Form as stipulated and enclose the following materials:
1. Application Letter
2. Completed Domestic Pharmaceutical Manufacturer GMP Assessment Application Form
3. The photocopy of Factory Registration Certificate or approve registration of alteration as requested (not required if the Registration Certificate is waived under the stipulations of the Factory Management Act); and photocopy of the Pharmaceutical Firm License for manufacturers.
4. Fees: Assessment fees are calculated in accordance with the Standards of Review Fees for the Registration of Western Medicines and Medical Devices.
5. The Chinese Site Master File (SMF) and its electronic copy
6. Factory layouts, which shall show the cleanliness levels of operational area/rooms, air flow directions, and diagrams of personnel and material flows; three copies in total
7. List of pharmaceutical machines, equipment, and analytical instruments and equipment (Attachment 3)
8. List of products manufactured by the GMP plant (with listed in accordance with the dosage form classification table of medicinal products) (Attachment 4) (not required for a brand new establishment)
9. Site Status Survey (Attachment 5)
10. Certificate of Analysis for at least two validation batches of products
11. List of In-house GMP-related Standard Operating Procedures (SOPs)
12. Validation Master Plan
13. Major changes since the previous follow-up inspection (including off-site warehouse(s) and outsourced activities) (not required for a brand new establishment)
(2) Follow-up inspections for domestic pharmaceutical manufacturers of medicinal products: Stipulated by Article 8 of the Regulations of Medicament Manufacturer Inspection, businesses shall autonomously submit their application six months prior to expiration of the medicament manufacturing license; the Domestic Pharmaceutical Manufacturer shall complete GMP Follow-Up Inspection Application Form , and related materials shall be enclosed:
2. Completed Domestic Pharmaceutical Manufacturer GMP Follow-Up Inspection Application Form
3. Fees: Inspection fees are calculated in accordance with the Standards of Review Fees for the Registration of Western Medicines and Medical Devices.
4. The Chinese Site Master File (SMF) and its electronic copy
5. Factory layouts, which shall show the cleanliness levels of operational area/rooms, air flow directions, and diagrams of personnel and materials; three copies in total
6. List of pharmaceutical machines, equipment, and analytical instruments and equipment (Attachment 2)
7. List of products manufactured by the GMP plant (with listed in accordance with the dosage form classification table of medicinal products) (Attachment 3)
8. Site Status Survey (Attachment 4)
9. Additional drug permits licenses for the manufacturer
10. A summary description of corrective actions made on deficiencies found during the previous two inspections
11. List of qualified starting material suppliers
12. Major changes since the previous follow-up inspection (including off-site warehouse(s) and outsourced activities)
Note: Please prepare the presentation materials in advance. Contents of the presentation are to be updated reflective of the latest status upon receipt of notification following the inspection, and provide the hard copy of the presentation on the date of inspection.