Validation Summary Report

Equipment: Nasal Spray Filling Machine

Subcategory: Nasal & Otic Products (Sterile / Non-Sterile)

Area: Production

DQ/IQ/OQ/PQ Flags

Design Qualification (DQ): Yes

Installation Qualification (IQ): Yes

Operational Qualification (OQ): Yes

Performance Qualification (PQ): Yes

Acceptance Criteria Reference

URS Annex1 Annex11

Key Critical Parameters

Fill accuracy, reject logic, audit trail

Requalification Frequency

12 Months

Summary

This Validation Summary Report outlines the validation activities performed on the Nasal Spray Filling Machine, confirming compliance with regulatory requirements and operational specifications.

Scope/Boundaries

The scope of this validation encompasses the design, installation, operation, and performance qualification of the Nasal Spray Filling Machine used for the production of sterile and non-sterile nasal and otic products.

Executed Protocol List

Design Qualification Protocol
Installation Qualification Protocol
Operational Qualification Protocol
Performance Qualification Protocol

Deviations Summary

No deviations were noted during the qualification process. All tests were executed as per the approved protocols.

CPP Verification Summary

Critical Process Parameters (CPPs) were verified and found to be within the acceptable limits as per the established acceptance criteria.

Conclusion

The Nasal Spray Filling Machine has successfully passed all qualification phases. It is deemed suitable for its intended use in the production of nasal and otic products.

Attachments Index

Design Qualification Protocol Document
Installation Qualification Protocol Document
Operational Qualification Protocol Document
Performance Qualification Protocol Document
Validation Summary Report Document

Approvals

__________________________

Validation Manager

Date: __________________