Implant Mixing Vessel (Jacketed SS) – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result
URS-001 The mixing vessel must maintain the specified temperature during the mixing process. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature log Pass/Fail
URS-002 The mixing speed must be adjustable and validated. M DQ-002 IQ-002 OQ-002 PQ-002 Mixing speed calibration report Pass/Fail
URS-003 The hold time for mixing must be defined and monitored. M DQ-003 IQ-003 OQ-003 PQ-003 Hold time records Pass/Fail
URS-004 The PLC must provide an audit trail for all operations. H DQ-004 IQ-004 OQ-004 PQ-004 PLC audit trail report Pass/Fail
See also  Inline Sterile Filtration Skid – IQ Protocol

Also Check:

Cooling Tunnel / Cooling Conveyor – PQ Protocol

Document Control: Document Number: PQ-CT-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared by: [Insert Name] Approved by: [Insert Name] Performance Qualification Protocol for Cooling Tunnel in Suppository Production Objective: To establish a validated process for the…

Magnetic Separator (Inline) – OQ Protocol

Document Control: Protocol Number: OQ-001 Version: 1.0 Effective Date: [Insert Date] Reviewed By: [Insert Name] Approval Date: [Insert Date] Operational Qualification Protocol for Inline Magnetic Separator Objective: To validate the operational performance of the Inline Magnetic Separator in the removal…

Bottle Unscrambler – IQ Protocol

Document Control: Version: 1.0 Date: [Insert Date] Prepared by: [Insert Name] Reviewed by: [Insert Name] Approved by: [Insert Name] Installation Qualification Protocol for Bottle Unscrambler Objective: To establish and document the Installation Qualification (IQ) for the Bottle Unscrambler used in…