What is QM?

The quality manual is a statement of the Company’s Quality Policy and Quality Objectives of the organization.

Which Guideline follow for preparation of QM?

US FDA 21 CFR Parts 210 and 211, Eudralex Volume 4 (Chapter – 1 Pharmaceuticals Quality System), ICH Q8, Q9 and Q10, Schedule M, PIC/S PI 002-3, WHO TRS 1025 - Annex 13,


Contents of QM

1. Introduction,

2. Scope,

3. Basics of Quality Management System

4. Quality Policy,

5. Quality Objective Quality Risk Management Policy

6. Company Profile,

7. Organization,

8. Regulatory Basics

9 Documentation For The Quality Management System

10. Document Structure Production of Quality Management System

11. Accompanying Quality Management System

12. Design/Project Management,

13. Qualification and Validation

14. Maintenance,

15. Health requirements,

16. Personnel hygiene requirements, including clothing

17. Complaints,

18. Product Recall,

19. Customer Management

20. Product Documentation,

21. Labeling And Packaging Control

22. Product Quality Review,

23. References


Review Period

Every Two Years

Storage Period

Perpetual