Pre-Conference Course "Fundamentals of Visual Inspection and AQL Testing"

Pre-Conference Course

Berlin, Germany

Course No 9344


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Helmut Gaus,
Director Quality Control at Boehringer Ingelheim

Dr Tobias Posset,
Head of Production Support Roche Diagnostics

Background

This training course on visual inspection will give you an understanding of the fundamentals of visual inspection of injectable products, applicable to manual and automated inspection. You will also learn how to implement an automated system on the basis of the manual inspection and how to qualify it. The course also includes an AQL training, that is you will learn how to use AQL tables to set defect limits and how to evaluate batch inspection data.

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, the latter as a draft, 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 the permission of re-testing and the usage of test-sets and setting AQL-Levels.

We will address those topics during the conference and discuss and answer questions on
The latest compendial requirements concerning particulate matter
Trending and monitoring of visual inspection data
Understanding the real meaning of detection capabilities
How to select an appropriate inspection system
Operation of automated system from qualification to routine

Target Group

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Programme


Skills you will develop through the course:
Ensuring GMP-compliance in manual inspection
Setting up a qualification strategy for automated systems
Usage of statistical tools for assessing inspection data
GMP-compliant routine operation of automated systems

Content of the course in detail:

General Requirements
Requirements of the Pharmacopeia
Defect categorisation
Test kits for training, qualification and routine

Manual Inspection
Qualification and training of personnel
Standardisation of working conditions
AQL in the manual inspection

From Manual to automated Inspection
Usage of the Knapp and the modified Knapp test
Cross validation during the PQ phase
Evaluation matrices

Automated Inspection
Importance of particle detection rates
System-Suitability, Requalification and revalidation

Evaluation of Inspection Data & batch Release
Trending of inspection results
AQL Testing
Re-inspection – allowed or not?


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