ASEAN Guidelines on GMP for Traditional Medicines - Preparation for Inspection

This content outlines the preparation activities for a Good Manufacturing Practice (GMP) inspection for Traditional Medicines/Health Supplements as specified by the ASEAN Guidelines. It covers the objectives, processes, inspection team formation, documentation review, and other key aspects involved in getting ready for a GMP inspection.

• ASEAN Guidelines
• GMP inspection
• Traditional Medicines
• Health Supplements
• Documentation review

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1. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements (TM/HS) PREPARATION FOR GMP INSPECTION Prepared by: Malaysia Approved by: ASEAN TMHS GMP Task Force Endorsed by: ASEAN TMHS Product Working Group 1

2. OBJECTIVE To review the activities in preparation for a GMP inspection 2 ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection

3. GMP INSPECTION PREPARATION Where & How Do We Start a GMP Inspection? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 3

4. GMP INSPECTION PREPARATION Generally the processes involve; A. Planning of inspections B. Formation of Inspection Team C. Review of documentations D. Prepare the Inspection Plan E. Pre inspection meeting F. Announcement of inspection ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 4

5. A. PLANNING Objective Inspector Type Timing Depth ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 5

6. B. INSPECTION TEAM Generally, one GMP Inspector will be involved per inspection. If required, a team consist of 2 inspector may be established. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 6

7. C. DOCUMENTATION REVIEW Company file Site Master File Manufacturing license ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 7

8. C. DOCUMENTATION REVIEW (cont.) Reports - Previous inspections Records - Complaints and recalls ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 8

9. C. DOCUMENTATION REVIEW (cont.) Checklist and/or Aide-memoire inspection ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 9

10. D. INSPECTION PLAN Develop inspection plan. Inspection plan need to be flexible so as to accommodate any changes required *Audit Plan Image 10 ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection

11. D. INSPECTION PLAN (cont.) Key elements may include : The type, scope, objective of the inspection Information from previous GMP inspection The time, date and place for the opening meeting The expected time and duration for each major inspection activity ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 11

12. D. INSPECTION PLAN (cont.) Key elements may include : Names of the inspection team members and their respective roles The organizational units to be inspected, taking into consideration if the company has multiple sites A tentative time, date and place for theexit meeting ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 12

13. D. INSPECTION PLAN (cont.) ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 13

14. D. INSPECTION PLAN (cont.) Inspectors Day / Time Inspector A Inspector B Inspector C 0900-0930 hrs 0930-1000 hrs 1000-1015 hrs Area / scope of inspections Opening Meeting Site Tour Break Document Records Review Inspections Break Continue Inspections End of Day 1 Inspection Inspectors Meeting Exit Meeting End of Inspection 1015-1300 hrs 1300-1400 hrs 1400-1600 hrs 1600-1630 1600 hrs 1630hrs ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 14

15. E. PRE-INSPECTION MEETING Prior to conducting the inspection Attended by all the inspectors. Issues to discuss; The objectives & scopes; The inspection plan; Chapters/areas covers by each inspector; Arrival time, transport, lodging, etc ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 15

16. INSPECTION TOOLS Inspection tools The ASEAN Guideline on GMP for TM/HS Last audit report Inspection agenda Note books Check list/aide-memoire Camera/recorder etc. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 16

17. F. INSPECTION ANNOUNCEMENT The company being inspected ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 17

18. REFERENCES NPRA PROCEDURE FOR CONDUCTING OF AN INSPECTION : PKP/200/308 18 ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection

19. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Preparation for GMP Inspection 19