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validation-protocol-template.md

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1# Analytical Procedure Validation Protocol

3> Every bracketed field is a decision to make and record **before** data collection.

4> `plan_validation.py --protocol` generates a framework-specific version of this document with the

5> required characteristics already listed.

7| Field | Value |

8| --- | --- |

9| Protocol number / version | [ ] |

10| Analytical procedure identifier and version | [ ] |

11| Product / analyte / matrix | [ ] |

12| Measured quality attribute | [ ] assay / impurity (quantitative) / impurity (limit) / identity / other |

13| Governing framework and section | [ ] |

14| Regional expectation confirmed with | [ ] |

15| Related development report (ICH Q14) | [ ] |

16| Author / date | [ ] |

17| Technical reviewer / date | [ ] |

18| Quality unit approval / date | [ ] |

Analytical Procedure Validation Protocol

Every bracketed field is a decision to make and record before data collection. plan_validation.py --protocol generates a framework-specific version of this document with the required characteristics already listed.

Field	Value
Protocol number / version	[ ]
Analytical procedure identifier and version	[ ]
Product / analyte / matrix	[ ]
Measured quality attribute	[ ] assay / impurity (quantitative) / impurity (limit) / identity / other
Governing framework and section	[ ]
Regional expectation confirmed with	[ ]
Related development report (ICH Q14)	[ ]
Author / date	[ ]
Technical reviewer / date	[ ]
Quality unit approval / date	[ ]

Raw lines 1 to 19

20## 1. Intended purpose and analytical target profile

22- Measurand and reporting unit: [ ]

23- Decision the result supports: [ ] release / stability / in-process / clinical / other

24- Specification or reporting limits served: [ ]

25- Required reportable range, derived from the specification: [ ]

26- Performance characteristics and criteria (formal ATP optional under Q14): [ ]

1. Intended purpose and analytical target profile

Measurand and reporting unit: [ ]
Decision the result supports: [ ] release / stability / in-process / clinical / other
Specification or reporting limits served: [ ]
Required reportable range, derived from the specification: [ ]
Performance characteristics and criteria (formal ATP optional under Q14): [ ]

Raw lines 20 to 27

28## 2. Pre-stated acceptance criteria

30State an appropriate criterion and its justification for every characteristic to be validated;

31identity or specificity criteria need not always be numeric. A

32criterion with no justification traceable to the specification, the ATP, or development data is not

33defensible.

36| --- | --- | --- | --- |

37| Specificity / selectivity | [ ] | [ ] | [ ] |

38| Response (calibration model) | [ ] | [ ] | [ ] |

39| Lower range limit (DL / QL) | [ ] | [ ] | [ ] |

40| Accuracy | [ ] | [ ] | [ ] |

41| Repeatability | [ ] | [ ] | [ ] |

42| Intermediate precision | [ ] | [ ] | [ ] |

43| Combined accuracy and precision, if used | [ ] | [ ] | [ ] |

45- Interval to be reported alongside accuracy and precision: [ ] confidence level [ ]

46- Does the criterion apply to the point estimate or to the whole interval? [ ]

2. Pre-stated acceptance criteria

State an appropriate criterion and its justification for every characteristic to be validated; identity or specificity criteria need not always be numeric. A criterion with no justification traceable to the specification, the ATP, or development data is not defensible.

Characteristic	Criterion	Justification	Framework reference
Specificity / selectivity	[ ]	[ ]	[ ]
Response (calibration model)	[ ]	[ ]	[ ]
Lower range limit (DL / QL)	[ ]	[ ]	[ ]
Accuracy	[ ]	[ ]	[ ]
Repeatability	[ ]	[ ]	[ ]
Intermediate precision	[ ]	[ ]	[ ]
Combined accuracy and precision, if used	[ ]	[ ]	[ ]

Interval to be reported alongside accuracy and precision: [ ] confidence level [ ]
Does the criterion apply to the point estimate or to the whole interval? [ ]

Raw lines 28 to 47

48## 3. Study design

51| --- | --- | --- | --- |

52| Response | [ ] (minimum 5 for ICH Q2(R2)) | [ ] | [ ] |

53| Accuracy | [ ] | [ ] | [ ] |

54| Repeatability | [ ] | [ ] | [ ] |

55| Intermediate precision | [ ] | [ ] | [ ] |

56| Lower range limit | [ ] | [ ] | [ ] |

58- Replicate count matches the routine reportable result: [ ] yes / [ ] justified deviation: [ ]

59- Calibration model and weighting, fixed in advance: [ ] unweighted / 1/x / 1/x² / non-linear / multivariate

60- Randomisation and run order: [ ]

61- Independent preparation, sample, group, and injection identifiers: [ ]

62- CI unit of independence and handling of unbalanced groups: [ ]

63- Prior knowledge or development data used in place of a test, with justification: [ ]

3. Study design

Characteristic	Levels	Replicates	Runs / days / analysts / instruments
Response	[ ] (minimum 5 for ICH Q2(R2))	[ ]	[ ]
Accuracy	[ ]	[ ]	[ ]
Repeatability	[ ]	[ ]	[ ]
Intermediate precision	[ ]	[ ]	[ ]
Lower range limit	[ ]	[ ]	[ ]

Replicate count matches the routine reportable result: [ ] yes / [ ] justified deviation: [ ]
Calibration model and weighting, fixed in advance: [ ] unweighted / 1/x / 1/x² / non-linear / multivariate
Randomisation and run order: [ ]
Independent preparation, sample, group, and injection identifiers: [ ]
CI unit of independence and handling of unbalanced groups: [ ]
Prior knowledge or development data used in place of a test, with justification: [ ]

Raw lines 48 to 64

65## 4. Materials

68| --- | --- | --- | --- | --- |

69| Reference material | [ ] | [ ] | [ ] | [ ] |

70| Impurity standards | [ ] | [ ] | [ ] | [ ] |

71| Blank / placebo matrix | [ ] | [ ] | — | [ ] |