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Introduction

Course Outline
Packaging Components

• Primary (contact) materials, their composition and properties
• Choosing the most appropriate material for specific applications
• Pre-treatment of components
• Requirements for receipt and testing
• Supplier considerations

Pack Design

• Contact packaging components
• Reducing the risk of mix-up
• Industrial codes of practice, e.g. PS 9000

The Packaging Process

• Packaging machinery – an overview
• Packaging operations – the GMP challenges
• Recalls – an overview
• In-process controls
• Automatic security and detection systems

Regulatory Aspects

• Stability testing requirements
• Labelling regulations
• Marketing Authorisation Application requirements for packaging components

The Route to the Patient

• Wholesale dealing – including a visit to a wholesaler
• Retail pharmacy visit

Concerns for the QP

• Counterfeits
• Controlled temperature storage and distribution

Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice. Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific question and concerns.

Course Tutors

• James Johnson, University of Strathclyde, Glasgow, UK
• Mr Mike Halliday, NSF Pharma Biotech Executive Director
• Dr Gary Rees
• Mrs Erika Notman

Useful links

Downloads

• Pharmaceutical Packaging Brochure
• QP Series 13 Programme
• QP FAQ
• NSF QP Training

Venue

Hilton York Hotel

City of York, Hilton York Hotel, 1 Tower Hill, York, YO1 9WD, United Kingdom

Useful links

Organised by

Contact information

Stella Pearson Smith
External Course Coordinator and QP Administrator, Pharma Biotech
Georgian House
22-24 West End
Kirkbymoorside
York
YO62 2AF
+44 (0)1751 432999
Contact us by email

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