Annex 15 – Page 19 – Pharma Validation

Raw Material Sampling Booth – OQ Protocol

Document ID: OQ-RMSB-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Prepared by: [Your Name] Approved by: [Approver’s Name] Operational Qualification Protocol for Raw Material Sampling Booth Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Raw…

Raw Material Sampling Booth – IQ Protocol

Document Number: IQ-RMSB-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Prepared by: [Your Name] Approved by: [Approver’s Name] Installation Qualification Protocol for Raw Material Sampling Booth Meta Description: This document outlines the Installation Qualification (IQ) protocol for the Raw…

Raw Material Sampling Booth – DQ Protocol

Document Control Number: DQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Design Qualification Protocol for Raw Material Sampling Booth Meta Description: This document outlines the Design Qualification Protocol for the Raw Material Sampling Booth used in API…

Raw Material Sampling Booth – Equipment Validation SOP

Standard Operating Procedure for the Validation of Raw Material Sampling Booth Equipment Validation, API Manufacturing, Raw Material Sampling Booth, Critical Equipment Purpose This SOP outlines the validation process for the Raw Material Sampling Booth used in the sampling of API…

Electronic Lab Notebook / Data Capture (if used for GMP) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Electronic Lab Notebook / Data Capture (if used for GMP) Subcategory: NDDS – CSV / Data Integrity for NDDS Area: System Equipment Identifier: [Insert Equipment Identifier] Qualification Flags DQ: Critical – Yes IQ: Critical –…

Electronic Lab Notebook / Data Capture (if used for GMP) – 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] [URS Statement 1] [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ Test Ref 1] [PQ…

Electronic Lab Notebook / Data Capture (if used for GMP) – Validation Summary Report (VSR) Template

Validation Summary Report Equipment: Electronic Lab Notebook / Data Capture Subcategory: NDDS – CSV / Data Integrity for NDDS Area: System DQ/IQ/OQ/PQ Flags: Critical/Yes/Yes/Yes Acceptance Criteria Reference: Audit trail e-signature access control retention Key Critical Parameters: After Change Requalification Frequency:…

Electronic Lab Notebook / Data Capture (if used for GMP) – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Information Equipment: Electronic Lab Notebook / Data Capture (if used for GMP) Area: System Criticality: Indirect Product Impact: Electronic records for GMP decisions Deviation Details Deviation Description: Classification Classification: Minor Major Critical Product/Patient Impact Product/Patient…

Electronic Lab Notebook / Data Capture (if used for GMP) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Electronic Lab Notebook / Data Capture (if used for GMP) Subcategory: NDDS – CSV / Data Integrity for NDDS Area: System DQ/IQ/OQ/PQ Flags: Critical/Yes/Yes/Yes CSV Required: Yes Pre-Start Training completed SOPs approved URS approved RA approved…

Electronic Lab Notebook / Data Capture (if used for GMP) – PQ Protocol

Document Control Number: PQ-ELN-001 Version: 1.0 Effective Date: [Insert Date] Reviewed by: [Insert Name] Approval Date: [Insert Date] Performance Qualification Protocol for Electronic Lab Notebook Objective: To validate the Electronic Lab Notebook (ELN) software for compliance with GMP requirements, ensuring…