Auto Coating Pan (Perforated Pan Coater) – Validation Summary Report (VSR) Template

Validation Summary Report

Equipment: Auto Coating Pan (Perforated Pan Coater)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Coating

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the Auto Coating Pan, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The equipment has been validated in accordance with URS Annex 11 acceptance criteria.

Scope and Boundaries

The scope of this validation encompasses the Auto Coating Pan’s functionality and its critical parameters within the Production/Coating area. The boundaries include all relevant operational conditions and performance metrics as outlined in the validation protocols.

Executed Protocol List

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

Deviations Summary

During the validation process, no significant deviations were noted that would impact the validation status of the Auto Coating Pan. All parameters were within the predefined acceptance criteria.

CPP Verification Summary

The following key critical parameters were verified and found to be within acceptable limits:

  • Inlet Temperature
  • Exhaust Temperature
  • Spray Rate
  • Pan Speed
  • PLC Functionality

Conclusion

Based on the executed protocols and verification of critical parameters, the Auto Coating Pan (Perforated Pan Coater) has been validated successfully. It meets all acceptance criteria as per URS Annex 11 and is deemed suitable for use in the production of solid dosage forms.

Attachments Index

  • Attachment A: DQ Protocol
  • Attachment B: IQ Protocol
  • Attachment C: OQ Protocol
  • Attachment D: PQ Protocol
  • Attachment E: Calibration Certificates
See also  Double Cone Blender – PQ Protocol

Approvals

This Validation Summary Report is approved by the following personnel:

  • Quality Assurance Manager: ____________________
  • Validation Specialist: ____________________
  • Production Manager: ____________________

Requalification Frequency

Requalification is scheduled every 24 months.

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