Tag: ICH Q9

Leak Test Machine (Bag – Pressure/Vacuum) – OQ Protocol

Document Control: Protocol Number: OQ-001 Version: 1.0 Effective Date: 2023-10-01 Reviewed By: [Name] Approved By: [Name] Operational Qualification Protocol for Leak Test Machine in IV Infusions Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Leak Test…

Leak Test Machine (Bag – Pressure/Vacuum) – IQ Protocol

Document ID: IQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Installation Qualification Protocol for Leak Test Machine in IV Infusions Meta Description: This document outlines the Installation Qualification (IQ) Protocol for the Leak Test Machine used in…

Leak Test Machine (Bag – Pressure/Vacuum) – DQ Protocol

Document Control: Document ID: DQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Design Qualification Protocol for Leak Test Machine in IV Infusions Meta Description: This document outlines the Design Qualification Protocol for the Leak Test Machine used…

SIP System – Qualification Certificate Template

Qualification Certificate Equipment: SIP System Subcategory: Prefilled Syringes & Cartridges Area: Production DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Frequency: 12 Months Next Due Date: [Next Due Date Placeholder] Protocol References: [Protocol References Placeholder] Execution Dates: [Execution Dates…

SIP System – 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 System must achieve specified sterilization temperature. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature logs URS-002 System must maintain required pressure…

SIP System – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Summary This Validation Summary Report (VSR) outlines the validation activities conducted for the SIP System used in the production of prefilled syringes and cartridges. The report includes a summary of the executed protocols, deviations, and critical…

SIP System – Deviation Impact Assessment

Deviation Impact Assessment Equipment: SIP System Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details [Insert details of the deviation here] Classification [Insert classification of the deviation here] Product/Patient Impact [Insert details of product/patient impact here] Data…

SIP System – Qualification Execution Checklist

Qualification Execution Checklist Equipment: SIP System Subcategory: Prefilled Syringes & Cartridges Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Checklist Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM status verified…

SIP System – PQ Protocol

Performance Qualification Protocol for SIP System in Prefilled Syringes & Cartridges Document Control: Document Number: PQ-SIP-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Objective The objective of this Performance Qualification (PQ) Protocol is to validate the SIP…