Japan GMP for Foreign Drug Manufacturers

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One of the key issues in getting drug approval in Japan is to meet Japanese GMP standards. To register a drug in Japan, foreign drug companies must ensure that their factories meet Japanese GMP standards. The Japanese MHLW issued its guidance document on GMP in 2004 titled – Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-Drugs. Generally, there are two different types of inspections for GMP compliance.

First, for partial change applications and new drug applications, a Japan GMP inspection is needed. During this inspection, all manufacturing and testing labs and other places indicated in the initial dossier review are required.

Second, after a drug gets approval, a GMP inspection is required every five years. For these audits, all manufacturing sites for the Drug product, Drug substances (API, excipient, and packaging materials), and storage facilities are normally audited.

Generally, all inspections are done on-site but there are some exceptions. All GMP inspection results and documents should be in Japanese and sent to the MHLW.

List of Requests for new CMO to prepare English Version Documents

1. Site Master File (Please provide the English version, BEFORE on-site audit)
2. Specification, including foreign materials and appearance defects, which agreed with MAH
3. SOP for GMP Organization and Responsible Person for each Quality System
4. SOP for Management of Blank Format of Master Batch Record
5. SOP for Document Control
6. SOP for Product Release
7. SOP for Change Control
8. List for Change Controls in the past two (2) years
9. SOP for Deviation Management
10. List for Deviations in the past two (2) years
11. SOP for Quality Information and Quality Complaint
12. SOP for Self-Inspection
13. SOP for Product Recall
14. SOP for GMP Training
15. SOP for Qualification Program for Personnel, including Operator for Visual Inspection
16. Quality Agreement with Marketing Authorization Holder
17. SOP for Quality Policy
18. SOP for Quality Manual
19. SOP for Product Quality Review
20. SOP for CAPA Management
21. SOP for Hygiene Control
22. SOP for Environmental Control
23. SOP for Supplier Control
24. SOP for External Contractor Management
25. Role and Responsibility of Senior Management
26. SOP for Management Review, including Internal Information transfer, Escalation to Senior Management, and Resource Management
27. SOP for Technology Transfer
28. SOP for Oversight for Quality System Management, including Quality Risk Management & Knowledge Management.
29. SOP for Rework/Reprocessing
30. SOP for Validation Master Plan
31. SOP for Control of Nitrosamines and Elemental Impurities
32. SOP for BSE/TSE control
33. SOP for Facility/Equipment Maintenance for Production and Analytical Testing Labs.
34. SOP for Computerized System Management, including qualification/Validation/　Security
35. SOP for Calibration
36. SOP for Utilities Controls, including Water System, Air Handling System, and Gases for Production.
37. SOP for Pest Control
38. Strategy for Prevention from Cross-contamination and Mixed-up
39. SOP for Incoming Materials Control
40. SOP for Storage Condition, including Rejected Materials & Status Control=
41. SOP for Inventory Control, including FIFO or FEFO
42. SOP for Quality Oversight of Material Supplier
43. SOP for Retest Control
44. SOP for Good Distribution Practice for raw materials, intermediates, and finished Products.
45. SOP for Manufacturing Instruction and Record
46. SOP for In-Process Control
47. SOP for Prevention of Foreign Materials, Cross-Contamination & Mixed-up during Manufacturing
48. SOP for Material Flow & Personnel Flow, Zoning, and Clothes Control
49. SOP for Process Validation
50. SOP for Cleaning Control, including Cleaning Procedure and Cleaning Validation
51. SOP for Holding Time during Production
52. SOP for Label Management, including insurance, storage and disposal of labels
53. SOP for Analytical Testing Instruction and Record
54. SOP for Sampling Operation and Sample Control
55. SOP for Regents, Test Solutions and Standard Materials Control
56. SOP for Control of Water Systems for Analytical Testing
57. SOP for Labeling Management for Release in Analytical Labs.
58. SOP for Reference and Retention Samples Management
59. SOP for Stability Testing
60. SOP for Analytical Testing Method Validation
61. SOP for OOS/OOT Investigation
62. SOP for Consistency Check between Manufacturing Batch Record and Submission Dossier

Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs.