Tag: Annex 11

TEM / SEM (as GMP-supporting analytics) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: TEM / SEM Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates: [Execution…

TEM / SEM (as GMP-supporting analytics) – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: TEM / SEM Area: QC/R&D Criticality: Major Product Impact: Indirect CSV Required: Yes Deviation Details Description of Deviation: [Insert detailed description of the deviation] Date of Deviation: [Insert date] Reported By: [Insert name]…

TEM / SEM (as GMP-supporting analytics) – Qualification Execution Checklist

Qualification Execution Checklist for TEM / SEM Equipment: TEM / SEM 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…

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

Document Control Document Title: Performance Qualification Protocol for TEM/SEM Equipment Validation Document Number: PQ-001 Version: 1.0 Effective Date: 2023-10-01 Reviewed By: [Name] Approval Date: [Date] Performance Qualification Protocol for TEM/SEM in Critical NDDS Analytics Meta Description: This document outlines the…

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

Operational Qualification Protocol for TEM and SEM Equipment Validation Document Control: Version: 1.0 Effective Date: [Insert Date] Reviewed By: [Insert Name] Approval Date: [Insert Date] Objective The objective of this Operational Qualification (OQ) protocol is to ensure that the TEM/SEM…