An Introduction to Pharmaceutical Packaging

This In-house course provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience.

In-house Training and Consultancy Services

Pharmaceutical packaging is a very specialised area with its own unique issues and problems. This In-house course will provide your team with a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. Whether you are new to the industry, have a basic understanding or are familiar with the area, this course will provide your team with useful knowledge and insights from an expert who has worked in the industry for over 25 years.

Your next step is to call us now on +44 (0)20 7749 4730 or email us at info@management.forum.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme

New Product Development (NPD) and role of packaging

  • Definition of packaging in a pharmaceutical context
  • Packaging in the pharmaceutical NPD process
  • Main packaging formats and materials – Quick overview
  • Key product requirements and characteristics
  • Consumer
  • Shelf life
  • Regulatory considerations
  • Marketing expectations

Regulatory and GMP requirements

  • Key packaging data for the MA/ Dossier
  • Common Technical Document
  • Summary of Product Characteristics (SmPC)

Pack testing and evaluation

  • Proving compatibility and ICH testing
  • Extractables and leachables
  • Extraction, migration and sorption studies

Key properties of various packaging materials/systems

  • Primary packaging:
    • Glass, plastics, metal – bottles, closures, blisters, manufacture, benefits, potential issues and testing
    • Laminates, tubes, aerosols – manufacture, benefits, potential issues and testing

*Key properties of various packaging materials/systems (continued)

  • Secondary packaging:
    • Pharmaceutical labelling – labels, leaflets (PILs), cartons
  • Tertiary /Trade/ Transit Packaging:
    • Top-line overview – corrugated and retail packaging
    • Materials, printing and supply chain issues
  • Main barriers and benefits of various packaging materials Key drivers for the pack performance
  • Supply chain implications on the packs
  • Specifications
  • Environment
  • Considerations of risk

Artwork generation and control

  • Establishing processes suitable to your business needs:
  • Wording
  • Templates
  • Creation
  • Workflow
  • Version control and authorisation

Some special requirements for packaging

  • Medical devices – Briefly: Categories
  • CE Marking Requirements
  • Child Resistant Closures
  • Tamper-Evidence
  • Braille
  • Readability
  • Patient compliance
  • Barcoding
  • Security and combating counterfeiting
    • Emerging requirements (e.g. 2D Data Matrix barcodes and serialisation)

Trade/supply chain requirements

  • Understanding the various markets and their particular requirements
  • Understanding trade requirements – e.g. Barcodes, Tamper Evidence etc.

Emerging pharmaceutical legislation

  • DQSA – Drug Quality and Security Act
  • Falsified Medicines Directive
  • Other markets

Recommended trainer

Penfold Christopher

Chris is a packaging professional with over 25 years packaging development and NPD experience working on £million-brands in the OTC, healthcare and Rx pharma arenas for ‘blue-chip’ multinational companies such as Glaxo (GSK), CIBA (Novartis), Boots Healthcare and Reckitt Benckiser Healthcare.

He is an MBA graduate and Chartered Marketer with extensive cross-functional experience in a broad spectrum of related disciplines, including marketing, supply chain, QC and production. An ‘International Player’ with experience working in various European countries, Middle East, North America and extended business trips to the Far East. Underpinned by proven interpersonal skills, the ability to make things happen and experience gained from independent international consultancy projects and running his own business, Design Cognition Ltd.

Chris’ technical competence and commercial foresight underpin his expertise in design strategy and management. He has many years experience in New Product Development, management and delivery and has pioneered outsourcing opportunities by developing processes, best practice and new ways of working to deliver top and bottom line business benefits – predominantly in the healthcare industry. This has included benefits through his large and reliable network of Far Eastern product and tooling sourcing, development and supply partners.

Chris’ extensive knowledge of all packaging principles and processes includes: plastics and plastic conversion processes, glass, laminates, paper/board together with knowledge of printing technology, reprographics and origination principles. He has an in-depth knowledge of healthcare legislation, including working at the ‘cutting edge’ of Braille implementation.