The An Introduction to Pharmaceutical Packaging focuses on the critical aspects of pharmaceutical packaging, emphasizing its importance for product safety, regulatory compliance, and market success.
Topics
- Regulatory and GMP requirements
- Common Technical Document
- Key packaging data for the MA/ Dossier
- Summary of Product Characteristics (SmPC)
- New Product Development (NPD) and role of packaging
- Packaging in the pharmaceutical NPD process
- Definition of packaging in a pharmaceutical context
- Key product requirements and characteristics
- Main packaging formats and materials - Quick overview
- Shelf life
- Consumer
- Marketing expectations
- Regulatory considerations
- Key properties of various packaging materials/systems
- Secondary packaging:
- Primary packaging:
- Main barriers and benefits of various packaging materials Key drivers for the pack performance
- Tertiary /Trade/ Transit Packaging:
- Specifications
- Supply chain implications on the packs
- Considerations of risk
- Environment
- Pack testing and evaluation
- Extractables and leachables
- Proving compatibility and ICH testing
- Extraction, migration and sorption studies
- Some special requirements for packaging
- CE Marking Requirements
- Medical devices - Briefly: Categories
- Tamper-Evidence
- Child Resistant Closures
- Readability
- Braille
- Barcoding
- Patient compliance
- Emerging requirements (e.g. 2D Data Matrix barcodes and serialisation)
- Security and combating counterfeiting
- Artwork generation and control
- Wording
- Establishing processes suitable to your business needs:
- Creation
- Templates
- Version control and authorisation
- Workflow
- Emerging pharmaceutical legislation
- Falsified Medicines Directive
- DQSA - Drug Quality and Security Act
- Other markets
- Trade/supply chain requirements
- Understanding trade requirements - e.g. Barcodes, Tamper Evidence etc
- Understanding the various markets and their particular requirements
Who should Attend
- Artwork producers
- Account managers
- Business developers
- Auditors
- Logistics personnel
- Clinical trial suppliers
- Project managers
- Packaging design/Labelling personnel
- Quality assurance and control personnel
- Purchasers
- Suppliers to the industry
- Regulatory personnel
- Technical writers
