Validation Summary Report (VSR)

Equipment: Dynamic Light Scattering (DLS) Analyzer

Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP)

Area: QC/R&D

Summary

This Validation Summary Report outlines the validation activities conducted for the Dynamic Light Scattering (DLS) Analyzer, focusing on the critical quality attributes (CQA) and critical process parameters (CPP) as defined in the User Requirements Specification (URS) Annex 11.

Scope/Boundaries

The scope of this validation includes the installation, operational, and performance qualifications of the DLS Analyzer within the QC/R&D laboratory. The boundaries encompass all functionalities related to size accuracy, polydispersity index (PDI), and repeatability.

Executed Protocol List

DQ Protocol
IQ Protocol
OQ Protocol
PQ Protocol

Deviations Summary

No deviations were noted during the validation process. All protocols were executed as per the approved plans.

CPP Verification Summary

The following key critical parameters were verified:

Size Accuracy: Passed
PDI: Passed
Repeatability: Passed
Audit Trail: Verified

Conclusion

The Dynamic Light Scattering (DLS) Analyzer has successfully met all validation requirements as per the URS Annex 11. The equipment is deemed qualified for use in QC/R&D activities and will be requalified every 12 months.

Attachments Index

Attachment 1: DQ Protocol Document
Attachment 2: IQ Protocol Document
Attachment 3: OQ Protocol Document
Attachment 4: PQ Protocol Document

Approvals

Approved by: [Name], [Title] – [Date]

Reviewed by: [Name], [Title] – [Date]