Qualification Execution Checklist for CIP Skid

Equipment: CIP Skid

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

Area: Production/Cleaning

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

CSV Required: Yes

Pre-Start Checks

Training completed for all personnel
Standard Operating Procedures (SOPs) reviewed and approved
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Qualification Protocols prepared
Protocols approved by Engineering
Protocols approved by Validation
Protocols approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures adhered to
Deviations documented and addressed

Review and Approvals

Engineering review completed
Validation review completed
QA review completed

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