Sprecher
Jean-Francois Decoster, UCB Pharma, Belgium
Sandra Hafner, AbbVie Deutschland,Germany
Dr Gerald Kindermann, F. Hoffmann-La Roche, Switzerland
Torsten Kneuss, Bayer Pharma, Germany
Horst Koller, HK Packaging Consulting, Switzerland
Dr Jörg Zürcher, Bayer Pharma, Germany
Zielsetzung
The focus of these 2 GMP Education Courses is on the development and routine control of pharmaceutical packaging systems.
In Course 1 participants will learn how to develop pharmaceutical packaging materials systematically, and how to translate the requirements of the Common Technical Document (CTD) to regulatory documents for packaging materials. Topics to be addressed include compendial standards, container closure integrity, and combination products.
Course 2 will focus on the testing of a variety of different packaging materials, as carried out in every incoming-goods laboratory in quality control. This includes the setting of sound and scientific specifications and Acceptable Quality Levels (AQLs), the control of dimensions, and the control of primary and secondary packaging materials.
Hintergrund
There is a great number of regulatory requirements on pharmaceutical packaging materials, in the pharmacopoeias, the GMP regulations, in the FDA guidances, etc.
Packaging materials also have to be described in the registration process of a drug product according to the requirements of the CTD.
The development of pharmaceutical packaging systems is an increasingly complex topic, which is reflected in the most recent requirements for combination products. To cover all relevant aspects a thorough target product profile needs to be set up. Not only regulatory requirements drive container closure system development, also current hot topics such as container closure integrity and glass delamination need to be considered as well.
Furthermore, the pharmaceutical manufacturer has to guarantee that only such packaging materials are used that are correctly printed on, in conformity with the specifications and in compliance with the regulatory requirements.
In order to determine the scope of the tests for the quality control of pharmaceutical packaging materials, the “Defect Evaluation Lists” have proved efficient. The responsibility for the tests lies now more and more with the manufacturers of packaging materials, while the pharmaceutical industry tries to reduce testing at the same time. However, as a precondition for this, additional QA measures, like supplier qualification, audits and supply agreements, have to be taken.
Zielgruppe
These GMP Education Courses are designed for employees working in pharmaceutical research and development, regulatory affairs, quality control, incoming goods control of packaging materials, and quality assurance departments. They are also directed at employees of suppliers of primary and secondary packaging materials for the pharmaceutical industry.
Programm
Programme Course 1:
Pharmaceutical Packaging Systems - Development
Regulatory Requirements applicable to Pharmaceutical Packaging Materials
Code of Federal Regulations (CFR)
US Guidance for Industry: Container Closure Systems
EC Guidance: Plastic Immediate Packaging Materials
Jean-Francois Decoster, UCB Pharma
Glass Delamination
What is delamination
What is the route cause
Contribution to delamination
How to avoid
How to control
Horst Koller, HK Packaging Consulting
Container Closure Integrity
Definition (Leakage)
Test methods
USP <1207>
Dr Jörg Zürcher, Bayer Pharma
Update of Compendial Standards
USP E&L <1663, 1664, 1665>?
Glass delamination – USP, Ph.Eur.
Rubber section JP
Ph.Eur. plastic materials, USP <661>
Jean-Francois Decoster, UCB Pharma
Packaging Related Topics of the Common Technical Document (CTD)
CTD structure (packaging related)
Translation of CTD requirements to Technical Regulatory Documents (TRD)
Best practice (blister and infusion bottle)
Dr Jörg Zürcher, Bayer Pharma
Development of Specifications for Container Closure Systems
Transforming a wish-list into a target profile
Conversion of a target profile into a specification
Critical parameters / acceptance criteria
Dr Jörg Zürcher, Bayer Pharma
Combination Products
Definitions and regulations
Development process
Documentation
Horst Koller, HK Packaging Consulting
Shelf-life of Packaging Components
Why is a defined shelf-life required?
How to define the shelf-life for packaging
components?
Re-Testing of packaging components
Torsten Kneuss, Bayer Pharma
Extractables/Leachables
Regulatory background
Principles of extractable and leachable testing
Potential extractables of different container materials
PQRI initiative on parenteral & ophthalmics
ICH genotoxic impurities vs. leachables values
Dr Jörg Zürcher, Bayer Pharma
Calibration/Qualification/Validation
Definitions
Regulatory requirements
Equipment lifecycle qualification for the control of packaging materials
Process validation
Dr Gerald Kindermann, F. Hoffmann-La Roche
End of Course 1 / Registration for Course 2
Programme Course 2: Pharmaceutical Packaging Systems - Quality Control
Defect Evaluation Lists
Manufacturing of moulded and tubular glass
containers
Application of AQL (Acceptable Quality Level)
Concept
Concept of Defect Evaluation List
Special Defect Evaluation Lists: Containers made of moulded and tubular glass
Torsten Kneuss, Bayer Pharma
Control of Printed Packaging Materials (60 min)
Legal requirements
Level of certification
Sample size & test procedures
Reference samples vs. retention samples (Annex 19)
Dr Gerald Kindermann, F. Hoffmann-La Roche
Quality Control of Primary Packaging Material
What is a suitable QC system for Primary Packaging Materials
Definition of critical parameters
Best practice in testing
AQL-testing, skip lot
Must to have QA systems (i.e. OOS, complaints)
Sample management incl. reference samples
Sandra Hafner, AbbVie Deutschland
Supplier Management
Supplier qualification and audits
Supply agreements and supplier qualification
Quality standards for suppliers
Cascade of Quality Control, reduced testing
Sampling plans
Dr Gerald Kindermann, F. Hoffmann-La Roche
Dimensional Checks in Packaging Development and Quality Control
Measurement equipment: overview
Application ranges
Practical examples
Torsten Kneuss, Bayer Pharma
Technical Specifications
Scope & content
Concept (proposal)
Template and practical example
Torsten Kneuss, Bayer Pharma
WORKSHOP I
Examples of Defective Packaging Materials
The aim of this workshop is to discuss in small discussion groups the evaluation of some defective packaging materials that are presented. Are the defects of these packaging materials critical or non-critical? Has the lot to be rejected or can it still be used?
Participants will learn how to apply the general recommendations of accepted and published Defect Evaluation Lists for specific and individual packaging materials.
Moderator: Torsten Kneuss
WORKSHOP II
Risk Management (Focus: FMEA)
The aim of this workshop is to define in small discussion groups the critical/major parameters to build up a suitable quality control system for your packaging materials. Focus will be on the practical application in a FMEA. The groups will evaluate
What, why, and where to test
Value of FMEA in the Quality Control concept for packaging materials
Strategies for reduced testing
Moderator: Dr Gerald Kindermann
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