Visual-Inspection-Guide-V5-October2025
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Visual Inspection of Medicinal
Products for Parenteral Use
A document by the ECA Foundation
Version 5.0; October 2025
Visual Inspection of Medicinal Products for Parenteral Use
© Copyright: ECA Foundation, Germany – Copying, editing and distributing require the written agreement of the ECA Foundation 1
Table of Contents
1 SCOPE ................................................................................................................. 4
2 MANUAL INSPECTION ............................................................................................ 4
3 SEMI-AUTOMATED INSPECTION .............................................................................. 6
4 AUTOMATED INSPECTION – QUALIFICATION, VALIDATION AND ROUTINE OPERATION .. 7
5 INSPECTION OF DIFFICULT-TO-INSPECT PRODUCTS AND CONTAINERS ....................... 9
6 DEFECT CLASSES .................................................................................................10
7 EVALUATION OF DEFECT CLASSES AND TRENDING ..................................................10
8 BATCH CERTIFICATION/RELEASE ...........................................................................12
9 CONCERNS REGARDING DISTRIBUTED PRODUCT .....................................................13
10 DEFINITIONS .......................................................................................................14
11 REFERENCES .......................................................................................................15
Visual Inspection of Medicinal Products for Parenteral Use
© Copyright: ECA Foundation, Germany – Copying, editing and distributing require the written agreement of the ECA Foundation 2
Visual Inspection of Medicinal Products for Parenteral Use
Authors – Acknowledgements
This ECA Good Practice Guide was developed by the Steering Committee of the ECA Visual
Inspection Working Group:
Dr Tobias Posset (Roche Diagnostics)
Felix Krumbein (Head of ECA Inspection Group)
Dr Helmut Gaus (Winsol, formerly Boehringer Ingelheim)
Martin Dearden (M&F Quality Pharma Solutions Ltd)
Dr Martin Becker (formerly Baxter Oncology)
Al Goodwin (Amgen)
Christof Langer (OSConsulting)
Dr Robert Eicher (Concept Heidelberg)
Version
Changes
Version 1.0
New Document
Version 2.0
Editorial adjustments
Inclusion of a false reject rate into the qualification of human inspectors
Clearer description of revalidation (chapter 3.4)
Inclusion of new chapter 4: Inspection of lyophilized product
Addition of the ASTM E2587-2 standard (Standard Practice for Use of
Control Charts in Statistical Process Control) in chapter 6 (Trending)
More detailed description of the batch release concerning the visual
inspection data (chapter 7)
Harmonization of the AQL limits with USP in chapter 7
Explanation on how to tighten AQL limits in chapter 7
Number of possible re-inspections adjusted to 2 (Chapter 6 & 7)
Inclusion of new chapter 8: Concerns regarding distributed product
Version 3.0
Editorial Adjustments
Usage of artificial test sets amended in chapter 2.2
Test of the color vision of human inspectors amended in chapter 2.2
Usage of format specific sets possible in qualification phases before PQ
(chapter 3.1)
Precision section 7 “Batch Release” including visible particles being allowed
within the AQL manual inspection according USP<790>
Reference list added as chapter 10
Version 3.1
Adding CCI statement (being out of scope for this document)
Precision of minimum AQL level for batch release
Deletion of the requirement for “sum of defects”
Version 3.2
Statement added regarding the Annex 1 changes:
1. manual inspection qualification condition under worst case conditions
(section 2.2)
2. use of glasses/corrective lenses within manual inspection (section 2.2)
Version 4.0
Editorial adjustments
Description of uninterrupted inspection times & breaks in manual visual
inspection adapted (2.3)
New chapter on semi-automated visual inspection (3)
Routine Operation: usage of test sets clarified (4.2)
Method reinspection may differ from method of original inspection (7.1)
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VisualInspectionofMedicinalProductsforParenteralUseAdocumentbytheECAFoundationVersion5.0;October2025VisualInspectionofMedicinalProductsforParenteralUse©Copyright:ECAFoundation,Germany–Copying,editinganddistributingrequirethewrittenagreementoftheECAFoundation1TableofContents1SCOPE.......................
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作者： 51zlzl
分类：专业资料
价格：80质量币
属性：16 页
大小：1.11MB
格式：PDF
时间：2025-11-25
