Live Online Conference - Control of Parenterals - Visual Inspection Systems

7/8 October 2020

Course No 18278

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Speakers

Dr Martin Becker, IDT Biologika
Martin Dearden, ECA Visual Inspection Group
Dr Helmut Gaus, WinSol, previously Boehringer Ingelheim
Roland Koch, Gasporox
Felix Krumbein, Roche
Christof Langer, OSConsulting
Dr Daniel Müller, GMP-Inspector
Dr Tobias Posset, Roche
Dr Brian Turnquist, Boon Logic

Objectives

Main topic of this course is the detection of defetcs like particles in injectables and their evaluation during batch release. 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, trending and batch release considerations.

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. But still, lots of questions arise, e.g. concerning re-testing, detection capabilities and revalidation of inspection systems.

Furthermore there has been a recognisable trend towards automated inspection machines throughout the last years. 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 systems.

We will address those topics during the conference and discuss and answer questions on

The latest compendial requirements concerning particulate matter
Compliance with the revised Annex 1
Training and qualification of operators in the manual inspection
Validation and operation of an automated inspection System
Trending and monitoring of visual inspection data
Correct AQL testing as part of the batch release
Re-inspection of defect fractions
Usage of artificial intelligence in visual inspection

Target Group

This conference is directed at staff from sterile operations, that is production, quality assurance and engineering. But also suppliers of primary packaging materials and inspections Technology are target group of this Event.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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 1 revison
Risk Management Considerations

Expectations of a GMP Inspector regarding Visual Inspection

Regulatory documents on visual inspection of parenterals (an overview)
Manual inspection, semi-automated inspection (personnel, working place, equipment, training & qualification)
Automated inspection (incl. validation strategy)
Routine operations, AQL testing, handling of (r)ejects
Inspection findings & experience

Manual Visual Inspection – Theory and Practical Aspects

Probabalistic nature of visual inspection
Defect categorisation
Differentiation of test kits for training, qualification and routine
Qualification and training of personnel
Standardisation of working conditions in Manual inspection
Usage of the Knapp and the modified Knapp test

Automated Visual Inspection – from Setup to Routine Use

Limitations of automated inspection
Setting up a qualification strategy for automated systems
Cross validation during the PQ phase of an automated system
Importance of particle detection rates
System suitability, requalification and revalidation
Inspection of eject fractions
The Roche Inspection systems: manual, semi-automated and fully automated inspection

Requirements, Composition, and Handling of Test Sets

Definition of defect categories
Set-up and composition of a test set
Test sets and their use for training, qualification and Routine
Handling and release of test sets
Documentation

Re-Inspection of Defect Fractions in Visual Inspection

Different scenarios will be covered such as:

Re-inspection or additional inspection of “grey-channel” units from (semi-) automated inspection
Re-inspection in case of exceeding alert limits or AQL failures
Focused re-inspection
Inspection approaches in case of investigations due to unexpected particles (e.g., to determine frequency of occurrence of visible particles when articles are found during release/stability testing

Automated Visual Inspection Based on Unsupervised Machine Learning

Vector segmentation using unsupervised machine learning
Characterizing variation using computer Vision
Learning normal variation in defect-free bottles
Visual inspection via anomaly detection

Particle Testing and the Correlation with Trending and Batch Release

Why do we Monitor (What is it all about)
Data and measurement
The AQL trap
Improvement process map
Investigation and routine analysis,
Release Process. “To AQL or not to AQL that is the Question”
Product release: “Falling off a log”

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