Tag: Annex 11

Solvent Addition / Metering Pump – Deviation Impact Assessment

Deviation Impact Assessment Equipment Details Equipment: Solvent Addition / Metering Pump Area: R&D/Production Criticality: Major Product Impact: Direct CSV Required: Yes Deviation Details Description of Deviation: Classification Deviation Classification: Major Minor Critical Product/Patient Impact Impact on Product/Patient: Data Integrity Impact…

Solvent Addition / Metering Pump – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Solvent Addition / Metering Pump Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.) Area: R&D/Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Checks Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified…

Solvent Addition / Metering Pump – PQ Protocol

Document Control: Document Number: PQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Performance Qualification Protocol for Solvent Addition / Metering Pump Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Solvent Addition / Metering…

Solvent Addition / Metering Pump – OQ Protocol

Operational Qualification Protocol for Metering Pump in R&D/Production Document Control Document Number: OQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Objective The objective of this Operational Qualification (OQ) protocol…

Solvent Addition / Metering Pump – IQ Protocol

Document Control Document Number: IQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Installation Qualification Protocol for Solvent Addition/Metering Pump Meta Description: This document outlines the Installation Qualification Protocol for…

Solvent Addition / Metering Pump – DQ Protocol

Document Control Document ID: DQ-001 Version: 1.0 Date: 2023-10-01 Prepared by: Validation Team Approved by: Quality Assurance Design Qualification Protocol for Solvent Addition/Metering Pump Meta Description: This document outlines the Design Qualification Protocol for the Solvent Addition/Metering Pump used in…

Solvent Addition / Metering Pump – Equipment Validation SOP

Standard Operating Procedure for the Validation of Solvent Addition/Metering Pump Purpose: This SOP outlines the validation process for the Solvent Addition/Metering Pump utilized in the controlled addition of solvents and active pharmaceutical ingredients (APIs) in the development and production of…

CCIT System (Vacuum Decay/HVLD) – Qualification Certificate Template

Qualification Certificate Equipment: CCIT System (Vacuum Decay/HVLD) Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: QC/Production DQ/IQ/OQ/PQ Flags: Yes / Yes / Yes / Yes Requalification Frequency: 12 Months Equipment Identifiers Serial Number: [Serial Number] Model Number: [Model Number]…

CCIT System (Vacuum Decay/HVLD) – 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_ID_1] The system shall provide a leak rate sensitivity audit trail. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1] [URS_ID_2] The…

CCIT System (Vacuum Decay/HVLD) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Equipment: CCIT System (Vacuum Decay/HVLD) Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: QC/Production DQ/IQ/OQ/PQ Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Acceptance Criteria Reference…