Visual Inspection of Parenterals

6/7 November 2024, Berlin, Germany

Course No. 20909

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Speakers

Dr. Daniel Müller

Dr. Daniel Müller

GMP Inspector

Dr Stephen Langille

Dr Stephen Langille

formerly FDA

Felix Krumbein

Felix Krumbein

Head ECA Visual Inspection Group

Martin Dearden

Martin Dearden

ECA Visual Inspection Group

Dr. Martin Becker

Dr. Martin Becker

Baxter Oncology

Christof Langer

Christof Langer

OSConsulting

Dr. Antonio Burazer

Dr. Antonio Burazer

Takeda Manufacturing Austria

Haluk Dönmez

Haluk Dönmez

B. Braun

Objectives

Main topic of this conference is the detection of defects like particles in injectables and their evaluation. Besides the current regulatory requirements with regards to particulate matter, routine 100% inspection of injectables will be addressed. Manual inspection as well as automated inspection systems will be covered, including validation, training, defect categories, AQL testing and trending.

Background

In most cases particles found in parenteral medicines will lead to a quarantined product or even to the recall of the product – as we have seen in the last years in the cases of several Pharmaceutical companies. Responsible staff in charge will have to start root cause analysis to find the source of the particles and will have to do an evaluation of batches already shipped.
There is still confusion within the global pharmaceutical Industry with regard to the requirements for testing for visible particles. After the USP chapters <790> and <1790> were published, things have become much clearer, at least for the US. In Europe chapter 5.17.2 of the European Pharmacopoeia now also gives further advice. However, many questions remain, e.g. concerning training, re-testing, detection capabilities and revalidation of inspection systems.
Furthermore, there has been a recognisable trend towards automated inspection machines throughout the last years. High expectations are also placed on the use of artificial intelligence. The challenge for pharmaceutical companies is to find a suitable machine for their products and to determine reasonable inspection parameters during qualification and validation. But also during routine process there are questions arising like re-testing and the usage of test-sets, doing AQL-Testing as well as the Adjustment of parameters of the vision system.
We will address those topics during the conference and discuss and answer questions on
  • The latest compendial requirements concerning particulate matter (EU & US)
  • How to comply with FDA’s new guidance on Visual Inspection
  • Compliance with the new EU Annex 1
  • Implementation of artificial intelligence in the automated inspection process
  • Reduction of false rejects in automated inspection Systems
  • How to inspect hard-to-inspect containers
  • How to set up a company-wide particle reduction Programme
  • How to transfer a visual inspection process during a site change
The fundamentals, such as training of operators in Manual inspection, AQL testing, trending and the validation of an AVI System are content of the Pre-Conference course on November 5th.

Target Group

This course is directed at staff from sterile operations involved in the 100% inspection process, that is production, quality and engineering. But also suppliers of primary packaging materials and inspections technology are target group of this event.

All participants receive the current version of ECA’s Best Practice Paper on “Visual Inspection” for free.

Programme

Visual Inspection of Parenterals

Seminar Programme as PDF

Regulatory Requirements for the Visual Inspection of Parenterals
  • Compendial requirements
    • 100% visual inspection & AQL testing
    • PharmEur, USP, JP - similarities and differences
  • News from the Annex I
  • Risk management considerations
Current FDA Requirements for Visual Inspection of Injectables (remote presentation)
  • Difference between current FDA and EU requirements
  • Use of quality risk management for the prevention of visible particulate contamination
  • FDA Visible Particulate case studies
  • Drug-Device combination product considerations
Visual Inspection of Parenterals – a GMP Inspector's View
  • Applicable regulations & guidance
  • Current requirements for pharmaceutical Industry
  • Expectations of a GMP-Inspector
  • Examples of observations
Presentation of the new Version 4.0 of the ECA Guide
The new version 4.0 of the ECA guide has recently been released. The presentation will introduce the guide itself and the changes in the new version. Among other things a chapter on semi-automated visual inspection has been added. Also, the description of uninterrupted inspection times & breaks in manual visual inspection has been adapted. And the Annex 1 requirement for ‘performance checks at regular intervals throughout the batch’ for AV inspection was taken into account.

Semiautomated Inspection – Advantages and Risks
  • Regulations for the use of SAVI
  • Technical setup of a SAVI System
  • Differences manual and semi-automated inspection
  • Qualification of inspection personal
  • Typical inspection errors and walkarounds
Practical Approaches for the Inspection of hard-to inspect Container Systems
Part I
  • Inspection of Bags
  • Single chamber and multi-chamber bags
  • Inspection of Blow-Fill-Seal containers
  • Inspection of Form-Fill-Seal containers
  • Manual, semi-automated and fully-automated approaches
  • Two step inspection
Part II
  •  Use of artificial intelligence
  • General Approach
  • Training and Machine Learning
  • Testing and Validation
  • Limitations
Establishing a Company-Wide Program for Harmonisation of Visual Inspection and Particle Reduction
This presentation will guide you through a success story of developing and executing a global, company-wide visual inspection and particle life cycle management program at a large Pharmaceutical company. Takeda has put a high focus on visual inspection and visible particles since 2020 and has achieved harmonization across their network of 15 sites and 13 CMOs as well as tremendous improvements in particle reduction and life cycle management. This presentation will provide an overview of the strategy, challenges, and achievements as well as learnings from the program.
  • Learnings from Takeda's global program
  • New challenges for particle LCM in small-scale manufacturing of ATMPs
  • Alignment with evolving regulations
  • Adaption to other companies
Transfer of a Visual Inspection Process
  • Manual inspection
    • Manual process to manual process (same manufacturing location)
    • Manual process to manual process (different manufacturing location)
    • Test set transfer?
    • Create new test set? How, why?
    • What does validation look like?
    • End goals and success (what are we trying to achieve?)
  • Automated inspection
    • Automated transfer: same machine (pitfalls)
    • Automated transfer: different machine (pitfalls)
    • End goals and success (what are we trying to achieve?)
Case Study Amgen: Use of AI in Visual inspection
 
Application, Project Planning and Qualification of AI in fully automated Visual Inspection
  • Development of robust, reliable and production-ready models in 4 phases
    • Phase 1: Problem identification & description
    • Phase 2a: Specification of inspection Concept
    • Phase 2b: Definition of the sample sets (artificial and production samples), creation of the datasets, clarification of the labelling strategy
    • Phase 3: Model design, training and verification - a risk-based Approach
    • Phase 4: Qualification & Validation
  • Processes & Technologies
    • Technologies for efficient image data acquisition, variable model technologies, transfer learning / pretrained models, labelling application
    • Documentation of model development: traceability, risk minimisation and build-up of confidence

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This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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