Particles in Parenterals State-of-the-art visual inspection of sterile medicinal products

16-17 September 2015

Berlin, Germany

Course No 9345

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Speakers

Scott Aldrich, USP
Dr Martin Becker, Siegfried Hameln
Martin Dearden, PaxVax Berna
Dr Lynne Ensor, FDA
Dr Helmut Gaus, Boehringer Ingelheim
Al Goodwin, Amgen
Dr Rodney Horder, Chair of the Ph.Eur. expert group 12; Pharmaceutical Consultant
Dr Tobias Posset, Roche
Dr Bernd Renger, Immediate Past Chair of the European QP Association
Marcel Uijlen, MSD

Objectives

Main topic of this conference is the detection of 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 training, AQL testing, trending, inspection equipment 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 2012, 2013 and 2014 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. There are several origins possible. Particles found can be categorised in extrinsic (not part of the process), intrinsic (part of the process) or inherent (product agglomerates). Nevertheless their source must be found and eliminated – batches already shipped have to be evaluated.

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

This conference is directed at specialists and executives from sterile operations, that is manufacturing, quality assurance and engineering. But also suppliers of primary packaging materials and inspections technology are target group of this conference.

Launch of ECA's Best Practice Paper on Visual Inspection, version 02

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. But also comments from other stakeholders and authorities as well were received, so that a revision process was initiated.

The second version of the paper is supposed to be distributed to all participants of this event. Take advantage of also discussing it with its authors.

Programme

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

An Update Regarding USP Chapters on Particles
Chapter 790 and 1790 for Visible Particles
Chapter 787 and 1787 for Subvisible Particles
Harmonized Chapter 788 and USP 1788

FDA’s current Expectations on Visual Inspection
FDA regulations relating to particulate matter in injectable drug products
Concerns regarding particulate matter contamination
GMP requirements for the visual inspection

Ph Eur and Particulates
Role of NPA's, COM, and EWG 12 in Ph Eur and how monographs/methods are
developed/updated
Contrast 2.9.20 with ECA Guide, recognising the different purpose
Overview of the current 2.9.19 PDG, with some history
Note of Group 12 initial opinion on USP Chapters <787> and <1787>
Opportunities for updating harmonised 2.9.19
Ask for user suggestions for updating 2.9.20 and 2.9.19

Presentation and discussion of ECA's Best Practice Paper on Visual Inspection,
Version 2.0

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. But also comments from other stakeholders and authorities as well were received, so that a revision process was initiated.

The second version of the paper is supposed to be distributed to all participants of this event. Take advantage of also discussing it with its authors.

Particle Testing and the Interaction of Production and QA
Monitoring and Trending
Improvements
Release process

Manual Inspection Capability to Detect Particulates in Parenteral products
What parameters impact the manual visual inspection capability
Understanding detection capability is key to ensuring assumptions made in process design, investigations, and re-inspections are accurate
What is the relation between detection capability and the size of the particle
There is no single detection capability that is universally applicable
What is the difference in detection capability between sites across the world

Automatic Visual Inspection Selection Process - Rocky Road from URS to FAT
User Requirement Specifications: Key do and don’t points
Defect Sets: When to use mimic solutions, Nist standards etc?
Manual / Machine: Clear understanding on Manual / Machine differences -
Knapp study?
Vendor Interaction: What level of technical interaction is needed?
3 Phases of Design review
Technology Roadmap: Will the system be obsolete in 2 years? What cameras to use?
How many inspection stations are actually needed?
Testing phase: This can happen well before FAT and will outline capability of systems
Factory Acceptance Testing: Confirmation whether above steps have been carried out correctly

Case Study Siegfried Hameln: Fully automated visual inspection of vials
Validation of the system
Validation strategy
Validation conduct and evaluation
Preparation and characterisation of test sets
Routine operation
Functional testing
Handling of rejects and re-inspection
Revalidation

Visual Inspection of lyophilized Products, Emulsions and Suspensions
Supplemental Inspection of non-transparent products
Constituted or withdrawn contents
The challenge of artifacts
Appropriate sampling size
Typical background particulate profile
X-Ray inspection

AQL in visual inspection
How mandatory is AQL testing?
Is AQL testing part of production or quality control?
How are quality levels determined and how is the number of units to be inspected calculated
What does AQL testing look like for lyophilized products?
What has to be done when AQL limits are exceeded?

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