Part 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
Glass Delamination
- What is delamination
- What is the route cause
- Contribution to delamination
- How to avoid
- How to control
Container Closure Integrity (CCI)
- Definition (Leakage)
- Test methods
- USP <1207>
Update of Compendial Standards
- USP E&L <1663>, <1664>
- Glass delamination – USP, Ph.Eur.
- Rubber section JP, Elastomers USP <381>
- Ph.Eur. plastic materials, USP <661>, <665>
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)
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
Combination Products
- Definitions and regulations
- Development process
- Documentation
Update on Medical Devices and Drug-Device Combination Products/Medical Devices
- New EU regulation on Medical Devices and how to be prepared
- Other upcoming regulations and guidances for combination products
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
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
End of Course 1 / Registration for Course 2
Part 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
Control of Printed Packaging Materials
- Legal requirements
- Level of certification
- Sample size & test procedures
- Reference samples vs. retention samples (Annex 19)
WORKSHOP I
Examples of Defective Glass 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.
Calibration/Qualification/Validation
- Definitions
- Regulatory requirements
- Equipment lifecycle qualification for the control of packaging materials
- Process validation
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
Supplier Management
- Supplier qualification and audits
- Supply agreements and supplier qualification
- Quality standards for suppliers
- Cascade of Quality Control, reduced testing
- Sampling plans
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
Dimensional Checks in Packaging Development and Quality Control
- Measurement equipment: overview
- Application ranges
- Practical examples
Technical Specifications
- Scope & content
- Concept (proposal)
- Template and practical example