GXP Inspection & Lab Accreditation
【Update Date:2018-10-18】unit:品質監督管理組
Purpose
In order to ensure that the quality and package integrity of all medicinal products delivered to patients are maintained during manufacturing, storage and transportation, and to reinforce supervision and management of supply chain quality, these regulations governing GDP inspections are established as required by the Pharmaceutical Affairs Act and the Regulations of Medicament Manufacturer Inspection.
Applicable to
1. Domestic manufacturer of western pharmaceuticals (including manufacturers of medicinal gases)
2. Logistics companies engaging in labeling and packaging operations of western pharmaceuticals
3. Pharmaceutical companies holding drug permits licenses
*When manufacturing and distribution licenses are both issued to the same company, the request forms shall still be submitted separately, however, it may be submitted at the same time.
*When the same person holds multiple distribution licenses, the request forms shall still be submitted separately. It is advised to submit at the same time for companies that are located at the same (or nearby) address.
Scope of Application
1. Initial GDP assessment
2. GMP routine inspection-combined GDP inspections
Legal Basis
Articles 57 and 71 of the Pharmaceutical Affairs Act
Inspection Criteria
Guide to Good Manufacturing Practice for Medicinal Products (Part III: Distribution) of the Pharmaceutical Good Manufacturing Practice Regulations.
Inspection Unit
Central competent health authority (Food and Drug Administration, TFDA); municipal or county (or county-level city) competent health authorities
Procedure
When requesting a GDP inspection or GMP routine inspection, the applicant shall enclose the following materials (please provide the information through the enclosed forms for Items 2 and 6—8).
1. Application Letter
2. Domestic GDP Inspection Application Form (Attachment 1)
3. Photocopy of the pharmaceutical firm's permit license
4. A copy of the latest Chinese Site Master File (SMF) and its electronic file
5. List of GDP-related Standard Operating Procedures (SOPs)
6. List of GDP-related equipment (Attachment 2)
7. List of drug permits licenses (Attachment 3)
8. Company Current status survey (Attachment 4)
9. The latest layout of the operating site, such as the configuration of the storage area and the workplace, the diagrams of personnel and the product flow.
10. Photos of inside the Finished product warehouse/workplace
11. For those having been visited by the Taiwan Generic Pharmaceutical Association as authorized by TFDA for assistance on GDP between 2012 and 2015, please also enclose:
(1) A summary of the time of visit, reports, findings, and corrections of deficiencies
(2) Major changes from the visit, to date
• Domestic GDP Inspection Application Form (Attachment 1)
• List of GDP-related equipment (Attachment 2)
• List of drug permits licenses (Attachment 3)