Method Qualification / Validation Report

A report on method development / qualifications/ validation shall provide all the information in a structured format for review and understanding. It shall contain experiment/parameter wise result discussion and summary. The report shall end into a proposed test method used for quality control analysis. Following are the contents (but not limited to) of the report:

1             OBJECTIVE:

(Objective of development studies as defined in protocol shall be provided).

2             INTRODUCTION

(Introduction shall include test method principle, application and scope of the test method, rationale for selecting the test method for specified sample analysis).

3             METHOD DEVELOPMENT/QUALIFICATION/VALIDATION SUMMARY

(This shall contain the overall strategy and the flow of the method development. Provide the basis on which initial method was defined. Also provide the rationale of the method and the flow of method developmental activity. Provide the summarized information of all the development and finalized parameters. Wherever required tabulated representation of parameters explored. Also mention the recommendation (if any))

4             DEFINITIONS & ABBREVIATIONS

(Provide definitions and abbreviations applicable to the report).

5             EXPERIMENTAL DETAILS

(Provide the details as below:

·         Material,

·         Equipment’s & Instruments,

·         Reagent and Solutions (Identified as critical reagents),

·         Sample Details,

·         Standard Details

·         Initial Method/Method Reference, Provide the source from where the method was taken or provide method reference.).

6             RESULTS & DISCUSSION

(Describe the method and mention the parameters which were taken up for development/qualification/validation with protocol reference wherever applicable).

6.1          Parameter 1

6.1.1      Experimental details/Test Procedure

(Mention the brief of the parameters selected and the procedure of the experiment).

6.1.2      Observation & Interpretation

(Provide details of observation, results and interpretation of results for parameter studied).

6.1.3      Conclusion & Statistical Analysis

(Conclusion and recommendation for each parameter studied).

6.1.4      Acceptance Criteria

(Wherever applicable)

6.1.5      Documentation

(Source data record and archival)

6.2          Parameter 2

and so on…….

7             DEVIATIONS & CORRECTIVE ACTIONS

(Wherever applicable)

8             CONCLUSION:

(Provide overall conclusion of the entire experimentation performed)

9             TEST METHOD

(Provide the details of the proposed test method with controls).

10          REVALIDATION CRITERIA:

(Wherever applicable)

11          REFERENCES

(List of references consulted during the experimental studies)

12          Enclosures

(Provide list of annexure and attachments of the report, this may include Protocol working copy (wherever applicable), Data Record (solution preparation and test & Analysis), calculation sheets and raw data)