An Introduction to Pharmaceutical Packaging

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