This course is intended for people who have a direct involvement in packaging operations within the pharmaceutical industry. This includes the production, development, technology, purchasing, QA/QC, marketing, regulatory and auditing functions.

 

This course provides the required packaging knowledge for people training to become "Qualified Persons" within the meaning of the EC legislation.

  

Course Leader

The course leader is an expert and specialist in packaging for the Pharmaceutical Industry. He has experience in packaging development, testing, legislation and project management across various applications

 

Course Description

This intensive three-day course will provide delegates with the knowledge of how packs, for packaging of ethical, OTC and veterinary medicines, are developed, manufactured, filled, transported, stored and used. A course project, completed by the delegates, emphasises the learning on each topic.

 

Learning Outcomes

At the end of the course, delegates will be able to:

• Identify the factors required for successful packaging including

1. Stability testing - shelf life
2. Regulatory needs
3. Specifications & testing
4. Quality - from design to audits

 

• Understand the conversion process of raw materials into packaging components to maximise quality and minimise recalls

• Understand the basics of artwork control allied to the printing processes
• Design for pack security - tamper evidence, child resistance & anti-counterfeiting
• Understand line layout to avoid rogues & optimise production
•  An appreciation of future trends & developments

 

Course Contents

Day One

Introduction to Pharmaceutical Packaging - Pack function, hazards, users, compliance, environmental issues, overall requirements and definitions

Packaging Development - Material & pack testing, test method selection, properties vs. performance, specifications, product stability, shelf life, line trialsCourse Project Workshop - Determine packaging brief for selected products

Glass - Use a packaging material, manufacture, types I, II, III & NP, conversion, treatments

Plastics - Use as a packaging material, manufacture, conversion, testing, migration

 

Day Two

Closures - Types, functions, features, TE/CRC and testing.

Flexible materials - Blisters, strips & sachets, manufacture, conversion, testing, properties

Metals - Tubes, aerosols, components, manufacture, conversion

Course Project Workshop - Determine primary packaging materials for selected products

Paper & Paperboard - Manufacture, properties, test methods, performance, conversion

Packaging Security - Controls, line clearance, machinery design, anti-counterfeiting, line layout

Transit Packaging - Distribution methods, temperature, pressure, moisture

Material Machinery Interface - Influences, testing, design, problem solving, validation

 

Day Three

Quality - Specifications, drawings, audits (in house & supplier), testing on line vs. goods inwards, GMP

Regulatory Aspects - Registration, legal requirements, ICHSterile Products - Requirements, sterilisation methods, particulates

Printing, Decorating & Labelling - Artwork control, advantages & limitations of printing methods, labels, leaflets, cartons

Course Project Workshop - Determine secondary & tertiary packaging materials for selected products

Future Developments - Legislation, trends, material developments

Course Summary & Evaluation - Review and feedback  

  

Course Fees

IOP Member: £850 + VAT* Non-Member: £975 + VAT**

*VAT = £148.75. Total inc. VAT = £998.75
**VAT = £170.63. Total inc. VAT = £1145.63

Fees include all notes, lunch and refreshments but are exclusive of individual travel and accommodation.

 

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