Sprecher
Dr Frank De Smedt, Nelson Labs Europe, Belgium
Dr Jochen Heinz, Transcoject, Germany
Torsten Kneuss, Bayer, Germany
Gaby Reckzügel, Boehringer Ingelheim, Germany
Maja Rybka, Quality Consultant, Germany
Dr Ingo Thorwest, Boehringer Ingelheim, Germany
Zielsetzung
This education course deals with the development, manufacture, use and control of plastic packaging materials for medicinal products, medical devices and combination products. The course gives you an update on the regulatory requirements and shows you how these requirements can be put into practice. One of the focus topics is the use of additives as well as their testing and assessment by means of extractables/leachables studies. You also get the latest information on child-resistant packaging. And the course subjects are rounded off from a GMP compliance point of view with the topics testing of plastic packaging materials and handling of plastic packaging materials during packaging.
Hintergrund
Requirements on the development, testing and registration of plastic packaging materials can among others be found in the EMA „Guideline on Plastic Immediate Packaging Materials“ of 2005 and the FDA Guidance for Industry „Container Closure Systems for Packaging Human Drugs and Biologics“.
The EMA guideline covers the specific requirements (data to be submitted) for plastic packaging materials intended to be in direct contact with the medicinal product. The guideline has to be applied in new registration applications or in variation applications.
According to the FDA guideline, each application should contain enough information to show that each proposed container closure system and its components are suitable for its intended use. This includes:
- Protection (light exposure, oxygen, moisture permeation, leakage)
- Compatibility
- Safety (extraction/toxicological evaluation studies)
- Performance (container closure system functionality, drug delivery)
Zielgruppe
The education course is especially designed for members of staff and executives from the pharmaceutical industry working in the field of research and development, regulatory affairs, quality control, incoming goods control of packaging materials, quality assurance, production and packaging. It is also directed at employees of suppliers manufacturing plastic primary packaging materials for the pharmaceutical industry.
Programm
Plastic for Medical Packaging: Manufacturing of Materials and Devices
- Overview of materials, additives and plastic auxiliaries
- Overview of manufacturing processes for polymers and devices
- Material and supplier selection criteria and contracting
- GMP requirements and compliance including documentation and testing of materials and processes
- ISO 15378:2006 – Particular requirements for primary packaging materials
- Recycling
- The big issue: Material changes
- FDA Guidance on Container Closure Systems
- EMA Guideline on plastic immediate packaging materials
- Pharmacopoeial regulations
- Miscellaneous requirements: BSE/TSE, Packaging Waste Directive, legislation on individual substances, etc.
- Definitions Medical Device (MD)/ Combination Product (CP) in EU and US
- MD/CP regulations for EU and US
- MD/CP Quality System Requirements
- Implementation in the pharmaceutical sector
- Transfer of the device regulatory requirements (e.g. Design Control) into the pharmaceutical development process
- General material and regulatory requirements for primary and secondary packaging and devices
- Material selection criteria
- Material properties and design
- Example: Prefilled plastic syringes
- Overview supplier management
- Supplier qualification
- Quality agreement
- Supplier review
- Requirements for plastic packaging materials manufacturer
- Applicable standards
- Auditing experiences
- Types of additives
- Their mode of action
- Use
- Function
- Physical Behaviour
- Regulatory requirements
- In which cases is extractables testing necessary?
- Best Practices for Extractables and Leachables testing
- Safety qualification process
- Definition
- Testing procedures
- Child resistance vs. Senior friendliness
- Examples
- Definition of Specifications Sampling plans, AQLs (Acceptable Quality Levels) and DEL (Defect Evaluation Lists)
- Common test methods
- Challenges
- Storage
- Processing
- IPC and Reconciliation
- Shopfloor requirements
- Blister integrity testing
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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