Validation Summary Report (VSR)

Equipment: Sachets & Stick Packs (Non-Sterile)

Subcategory: Powders

Area: Equipment

DQ/IQ/OQ/PQ Flags: Critical/Yes/Yes/Yes

Acceptance Criteria Reference: Mixing speed, temp, blending time, PLC audit trail

Key Critical Parameters: 12M

Requalification Frequency: Yes

Summary

This Validation Summary Report outlines the validation activities performed on the Sachets & Stick Packs equipment used for non-sterile powders. The report summarizes the execution of the DQ, IQ, OQ, and PQ protocols, as well as any deviations encountered during the validation process.

Scope/Boundaries

The scope of this validation includes the assessment of the equipment’s performance in accordance with defined protocols, focusing on critical parameters that impact product quality and safety.

Executed Protocol List

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Deviations Summary

No critical deviations were noted during the validation process. All parameters were within specified acceptance criteria.

CPP Verification Summary

All critical process parameters (CPPs) were verified and confirmed to meet the acceptance criteria established during the validation planning phase.

Conclusion

The validation of the Sachets & Stick Packs equipment for non-sterile powders has been successfully completed. All critical parameters were met, and the equipment is deemed suitable for its intended use.

Attachments Index

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

Approvals

Prepared by: [Name],