Particles in Parenterals PLUS Pre-Conference Course "Fundamentals of Visual Inspection & AQL Testing"

Programme

Pre-Conference Course "Fundamentals of Visual Inspection & AQL Testing"
on 27 September

The training course on visual inspection which takes place the day before the Particles Conference gives 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. 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.

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

• Automated inspection
• Importance of particle detection rates
• System-Suitability, requalification and revalidation

Course Trainer:
Dr Helmut Gaus, Director Quality Control at Boehringer Ingelheim
Dr Tobias Posset, Head of Production Support Roche Diagnostics

Particles in Parenterals Conference
28-29 September 2016,Barcelona, Spain

Regulatory Requirements for the visual inspection of parenterals

• Compendial Requirements
• 100 % visual inspection & AQL testing
• PharmEur, USP, JP - similarities and differences
• GMP Expectations
• Manual inspection
• Automated Inspection
• Risk Management Considerations

FDA’s current thinking on particles and testing of parenterals

• A summary of recent recall data due to visible particulates
• The FDA’s take on AQL testing
• Training and qualification of visual inspection staff
• Automated inspection validation
• A life-cycle approach to visible particle inspection and control

Presentation and discussion of the ECA Best Practice Paper on Visual Inspection
The best practice paper has been originally developed by the advisory board of the ECA Visual Inspection Group. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues. The first version of this paper has been published in September 2014 in Copenhagen. It has gained a broad acceptance in the industry afterwards. The current version as well as planned updates will be explained and discussed in Barcelona

Re-inspection of defect fractions - statistical evaluation

• Mathematical description of inspection processes
• Strategies for reinspection of defect fractions
• Acceptance criteria for reinspection of defect fractions
• Statistical evaluation
• Design of the reinspection processes

Particle Testing and the interaction of production and QA

• Monitoring and Trending
• Improvements
• Release process

Case Study MSD: Qualification/Validation of an automated system and routine operation

• Training/Development test set
• Qualification test set
• Daily set up test set for automated system
• Creating defects
• Process Control Limits

In-line automated visual particle inspection of "Blow Fill Seal" containers for injectable drug products
A case study for line integration and validation in combination with related threshold studies
In this presentation a new 100% particle inspection machine at full production speed is presented along with real time case studies for line integration and threshold studies of current pharmaceutical products. It highlights also the benefits of this inspection process in relation to sensitive products like proteins or highly foaming liquids, which usually are disliked by machine vision inspection. Also a validation approach using threshold studies from human inspections based on a Knapp test approach as well as the related pseudo Knapp test results are presented.
Reduction and identification of particles

• Handling of the particle load within the production area
• Projects to reduce visible particles
• Analytics and identification of visible particles
• Example: particles on stoppers - analytic-limits and requirements

Case Study Amgen: How to set up in-line and desktop AVI systems
Summary of in-line AVI systems with focus on detection capability
Desktop AVI systems and where they can be used
Qualification of a desktop AVI system
One future roadmap for Automatic Visual Inspection
Quality requirements for injections shipped to the Japanese market

• Japanese sensitivity for qualities of general and pharmaceutical products
• General requirements for cosmetic qualities by Japanese medical agencies
• Requirements for direct container suppliers by Japanese pharmaceutical companies
• Requirements for qualities and production/inspection control by Japanese pharmaceutical companies/authorities/pharmacopeia
Control of packaging materials: Visual inspection of glass containers

• Avoiding particles and other defects during glass manufacture
• IPCs and final quality tests the suppler site
• Vision Systems, machine setup and specifications