Description
This module covers the requirements for the qualification of laboratory instruments, including IQ, OQ, and PQ. The relationship between vendors, user requirements specifications and qualification are explained. The different approach to simple and complex instruments is addressed, and specifications and calibration requirements for spectrophotometers, chromatographic systems and dissolution apparatus are reviewed.
Course Objectives
Students completing this course should be able to:
- Describe the steps involved in IQ and OQ of instruments
- State the requirements for software qualification
- List chromatography instrument calibration requirements and frequency
- List general lab instrument calibration requirements and frequency
- State the QC expectations for instrument logbooks
Course Outline
INTRODUCTION
1. Introduction
2. Instrument calibration
3. Useful definitions
4. Good QC laboratory data
5. The V model
6. Applying the V model
7. Simple vs complex instruments
8. Qualification phases
9. Vendors
10. Lab instrument specialist
11. Review
INSTRUMENT QUALIFICATION
12. Introduction
13. Instrument URS
14. Qualification approach
15. Steps of IQ
16. IQ: USP definition
17. OQ Phase
18. OQ: USP definition
19. HPLC OQ
20. PQ Phase
21. HPLC PQ
22. PQ: USP definition
23. System suitability testing
24. SST acceptance criteria
25. Qualification protocols
26. Protocol execution
27. Summary
28. Review
CALIBRATION RECORDS
29. Introduction
30. Calibration and performance checks
31. Precision and accuracy
32. GLP identification rules
33. Scope of calibration
34. Calibration rules
35. Schedules
36. Calibration records
37. Review
LABORATORY SOFTWARE QUALIFICATION
38. Introduction
39. Classes of software
40. Software qualification rules
41. Software examples
42. Qualifying spreadsheets
43. Review I
44. Review II
CHROMATOGRAPHIC SYSTEMS
45. Introduction
46. HPLC/GC
47. HPLC components
48. Typical specifications
49. Column maintenance
50. Mobile phase
51. SST
SPECTROPHOTOMETRIC SYSTEMS
52. Introduction
53. Types of systems
54. Operation principles
55. Typical specifications
56. Cell specifications
57. Calibration tasks I
58. Calibration tasks II
DISSOLUTION APPARATUS
59. Introduction
60. Dissolution apparatus
61. Performance parameters
62. Typical specifications
63. Calibration tasks
64. Review
INSTRUMENT LOGBOOKS AND EQUIPMENT HISTORY
65. Introduction
66. Purpose
67. What to record
68. Review
CONCLUSION
69. Summary