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	[ ]

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 (the ATP): [ ]

2. Pre-stated acceptance criteria

State a numeric criterion and its justification for every characteristic to be validated. 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? [ ]

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

4. Materials

Item	Identity / grade	Lot	Assigned value and uncertainty	Expiry
Reference material	[ ]	[ ]	[ ]	[ ]
Impurity standards	[ ]	[ ]	[ ]	[ ]
Blank / placebo matrix	[ ]	[ ]	—	[ ]

5. Sample and solution handling

• Preparation procedure and dilution scheme: [ ]
• Solution stability window to be demonstrated: [ ]
• Storage conditions: [ ]

6. Specificity and stability-indicating properties

• Interferences to be challenged: [ ]
• Forced degradation conditions, if a stability-indicating claim is made: [ ]
• Orthogonal procedure, if used, and its accuracy: [ ]

7. Robustness (normally development, ICH Q14)

Parameter	Nominal	Range varied	Effect assessed on
[ ]	[ ]	[ ]	[ ]

8. Statistical treatment

• Software, version, and how calculations are verified: [ ]
• Handling of outliers, stated in advance: [ ]
• Scripts to be used and their output retained as records: [ ]

9. Deviations and data integrity

• Deviation identification, assessment and approval route: [ ]
• All results will be reported, including out-of-criteria values: [ ] confirmed
• Raw data location, audit trail, and review: [ ]

10. Approvals

Role	Name	Signature	Date
Author
Technical reviewer
Quality unit