Tag: Annex 11

TEM / SEM (as GMP-supporting analytics) – IQ Protocol

Document Control Document Number: IQ-001 Version: 1.0 Effective Date: [Insert Date] Prepared by: [Insert Name] Reviewed by: [Insert Name] Approved by: [Insert Name] Installation Qualification Protocol for TEM/SEM in NDDS Analytics Meta Description: This document outlines the Installation Qualification (IQ)…

TEM / SEM (as GMP-supporting analytics) – DQ Protocol

Document Control Document Number: DQ-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Prepared by: [Name] Approved by: [Name] Design Qualification Protocol for TEM/SEM in NDDS Critical Analytics Meta Description: This document outlines the Design Qualification (DQ) protocol for TEM/SEM…

TEM / SEM (as GMP-supporting analytics) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of TEM/SEM in NDDS Analytics Purpose: This SOP outlines the validation process for the Transmission Electron Microscope (TEM) and Scanning Electron Microscope (SEM) used for Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)…

Nano Tracking Analysis (NTA) System – Qualification Certificate Template

Qualification Certificate Equipment: Nano Tracking Analysis (NTA) System Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement…

Nano Tracking Analysis (NTA) System – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Equipment: Nano Tracking Analysis (NTA) System Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes Acceptance Criteria Reference: URS Annex11 Key Critical Parameters: Accuracy, Data Integrity, Audit Trail Requalification Frequency: 12 Months Summary…

Nano Tracking Analysis (NTA) System – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: Nano Tracking Analysis (NTA) System Area: QC/R&D Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Deviation Description: [Enter detailed description of the deviation] Date of Deviation: [Enter date] Reported By: [Enter…

Nano Tracking Analysis (NTA) System – Qualification Execution Checklist

Qualification Execution Checklist for Nano Tracking Analysis (NTA) System Equipment Details Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified…

Nano Tracking Analysis (NTA) System – PQ Protocol

Document Control: Document Number: PQ-NTA-001 Version: 1.0 Effective Date: 2023-10-01 Reviewed By: [Name] Approval Date: 2023-10-01 Performance Qualification Protocol for Nano Tracking Analysis System Tags: Equipment Validation, NDDS, Critical Analytics, NTA System, PQ Protocol Objective The objective of this Performance…

Nano Tracking Analysis (NTA) System – OQ Protocol

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] Operational Qualification Protocol for Nano Tracking Analysis System Objective: The purpose of this Operational Qualification (OQ) protocol…