GAMP Good Practice Guide

A Risk-Based Approach to Calibration

Management

Second Edition

GAMP® 우수 사례 가이드 : 조정 관리에 대한 위험 기반 접근법 (제 2 판)은 장비 위험 평가, 교정 프로그램 관리, 문서화 및 시정 조치에 대한 체계적인 접근 방법을 제공하는 교정 관리 시스템 설정에 대한 지침을 제공하며, 규정 준수에 필수적입니다. 이 지침서는 변화하는 환경을 다루기 위해 업데이트되었으며 동시에 국제 GxP 규제 기대치를 충족시킵니다.

이 안내서는 변화하는 환경에 대처할 수 있도록 업데이트되었으며 발행 당시의 국제 GxP 규정 기대치를 여전히 만족시킵니다. 범위는 관련 산업, 실험실 및 분석 장비를 포함하도록 확대되었습니다

 

 

Table of Contents

1        Introduction................................................................................................... 7

1.1     Rationale............................................................................................................................ 7

1.2     New and Revised Material..................................................................................................... 8

1.3     Purpose............................................................................................................................... 9

1.4     Scope............................................................................................................................... 10

1.5     Regulatory Requirements..................................................................................................... 11

1.6     Business Benefits................................................................................................................. 11

1.7     Structure............................................................................................................................ 11

2        Key Concepts and Terms................................................................................. 13

2.1     Key Concepts..................................................................................................................... 13

2.2     Key Terms......................................................................................................................... 13

3        Key Roles and Responsibilities......................................................................... 17

4      Instrumentation Life Cycle Approach................................................................. 19

5        Common Practices........................................................................................ 21

5.1     Criticality Risk Assessment.................................................................................................... 21

5.2     Change Management......................................................................................................... 28

5.3     Calibration Management Software........................................................................................ 30

5.4     Auditing............................................................................................................................ 31

5.5     Measurement Capability and the Potential Influence of Measurement Uncertainty........................ 34

6        Project Phase................................................................................................ 41

6.1     Roles and Responsibilities in the Project Phase......................................................................... 43

6.2     Instrument Tagging/Identification.......................................................................................... 44

6.3     Instrument Selection............................................................................................................ 45

6.4     Automation and Smart Instrumentation.................................................................................. 49

6.5     Supplier Selection............................................................................................................... 50

6.6     Instrument Verification......................................................................................................... 51

7        Operation Phase........................................................................................... 53

7.1     Roles and Responsibilities in the Project Phase......................................................................... 54

7.2     Calibration Documentation................................................................................................... 55

7.3     Calibration Methodology...................................................................................................... 58

7.4     Calibration Process.............................................................................................................. 60

7.5     Training............................................................................................................................. 62

7.6     Management of Third Party Calibration.................................................................................. 63

7.7     Calibration Non-Conformance............................................................................................... 64

7.8     Decommissioning of Instruments........................................................................................... 66

8      Laboratory and Analytical Equipment................................................................ 69

9        Other Considerations..................................................................................... 71

9.1     Fieldbus............................................................................................................................. 71

9.2     Auto Calibration................................................................................................................. 71

9.3     On-Line Alerts..................................................................................................................... 72

9.4     Self Documenting Calibrators/Asset Management Systems....................................................... 72

9.5     Process Analytical Technology............................................................................................... 72

10      Appendix 1 – Worked Example Showing Tolerance............................................. 75

11      Appendix 2 – Measurement Uncertainty Calculation – Examples............................ 81

12    Appendix 3 – Calibration Management Software................................................ 85

12.1  User Requirements Specification......................................................................................... 85

13      Appendix 4 – Instrument Tagging Process.......................................................... 91

14      Appendix 5 – Indicative Regulatory Requirements............................................... 99

15      Appendix 6 – List of Attachments.................................................................... 105

16      Appendix 7 – References............................................................................... 107

16.1   References....................................................................................................................... 107

16.2   Further Reading................................................................................................................ 108

17    Appendix 8 – Glossary.................................................................................. 109

17.1  Abbreviations and Acronyms............................................................................................. 109

17.2  Definitions         110