Jean-Francois Decoster, UCB Pharma, Belgium
Sandra Hafner, AbbVie Deutschland, Germany
Dr Gerald Kindermann, F. Hoffmann-La Roche, Switzerland
Torsten Kneuss, Bayer, Germany
Horst Koller, HK Packaging Consulting, Switzerland
Dr Jörg Zürcher, Bayer, Germany
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.
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.
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.
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
Container Closure Integrity
- What is delamination
- What is the route cause
- Contribution to delamination
- How to avoid
- How to control
Update of Compendial Standards
- Definition (Leakage)
- Test methods
- USP <1207>
Packaging Related Topics of the Common Technical Document (CTD)
- USP E&L <1663, 1664, 1665>?
- Glass delamination – USP, Ph.Eur.
- Rubber section JP
- Ph.Eur. plastic materials, USP <661>
Development of Specifications for Container Closure Systems
- CTD structure (packaging related)
- Translation of CTD requirements to Technical Regulatory Documents (TRD)
- Best practice (blister and infusion bottle)
- Transforming a wish-list into a target profile
- Conversion of a target profile into a specification
- Critical parameters / acceptance criteria
Update on Medical Devices and Drug-Device Combination Products/Medical Devices
- Definitions and regulations
- Development process
Shelf-life of Packaging Components
- New EU regulation on Medical Devices and how to be prepared
- Other upcoming regulations and guidances for combination products
- Why is a defined shelf-life required?
- How to define the shelf-life for packaging components?
- Re-Testing of packaging components
- 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
End of Course 1 / Registration for Course 2
Programme Course 2: Pharmaceutical Packaging Systems - Quality Control
Defect Evaluation Lists
Control of Printed Packaging Materials
- 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
- Legal requirements
- Level of certification
- Sample size & test procedures
- Reference samples vs. retention samples (Annex 19)
Quality Control of Primary Packaging Material
- Regulatory requirements
- Equipment lifecycle qualification for the control of packaging materials
- Process validation
- 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
Dimensional Checks in Packaging Development and Quality Control
- Supplier qualification and audits
- Supply agreements and supplier qualification
- Quality standards for suppliers
- Cascade of Quality Control, reduced testing
- Sampling plans
- Measurement equipment: overview
- Application ranges
- Practical examples
- Scope & content
- Concept (proposal)
- Template and practical example
Examples of Defective Glass Packaging Materials (60 min)
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.
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