QP Pharmaceutical Packaging

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3 Day/s

CPD Hours: 21

Classroom, online, in-house

RSC approved

The QP needs to fully understand the challenges and risks involved in packaging operations in the Pharmaceutical Industry. A significant percentage of all product related complaints and recalls continue to be related to packaging issues. This course closely examines the key stages of pharmaceutical packaging relevant to the QP, from component manufacture and supply to final product release including QP certification.


Packaging Site Visit
The courses running in Barnstaple, incorporate a site visit to a high volume Solid Dose Packing facility. This will allow participants to see how the theory can be applied in practice.
RSC Logo Approved Training High Res (1)

This course has been designed specifically with trainee QP’s in mind as they need to ensure they understand the plethora of operations and challenges associated with Pharmaceutical Packaging. As the module includes a thorough look at all important aspects, it will also appeal to existing QPs wishing to update their knowledge. In addition, it will also be of direct relevance and benefit to packaging supervisors/managers, quality personnel working in packing departments, packaging technologists and engineers supporting packing operations.

The course includes the following topics and reinforced using group exercises:


  • Day 1
    • What is Pharmaceutical Packaging?
    • Food vs Pharmaceutical Packaging
    • Primary Packaging Materials
    • Braille
    • Primary Packaging Material Changes
    • Printed Packaging Materials Labelling
    • What is wrong with the Printed Cartons?
    • Packing GMP
  • Day 2
    • Printed Packaging Material Suppliers - ISO 9001/ISO 15378/ PS9000
    • Sampling of Packaging Materials
    • Using ISO 2859 Tables
    • Artwork Origination and Control
    • Child Resistance & Tamper Evidence
    • Falsified Medicines Directive and Supply Chain Security
    • Controlled Drugs
    • Parallel Trade Repacking
    • QP Situations in Packing Part 1
  • Day 3
    • Line Clearance
    • Packing Validation
    • Packing of Clinical Trials Materials
    • Start up and In-Process Controls
    • Finished Product Batch Release
    • QP Situations on Packing Part 2

    By the end of the course you will:


    • Have a good understanding of the various packaging materials used, their characteristics and how they are manufactured
    • Appreciate the need to understand and work with suppliers of all packaging components; especially printed packaging components
    • Understand the risks involved in packing operations and what the QP needs to be particularly aware of
    • Gain practical information on how to improve the control of packing operations
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Meet the tutors

Jenni Newcombe

Jenni has 27 years’ experience in the Pharmaceutical industry, 8 in Quality Control and the remainder in Quality Assurance whilst working as a senior quality professional in a high volume fast paced global Generic environment. Currently acting as a Qualified Person and a Responsible Person, she has extensive experience in GMP and GDP. Jenni is currently working as the of Director Supplier Quality, Qualified Person/Responsible Person for Accord-UK Ltd (formerly Actavis UK Ltd) based in Barnstaple, N. Devon. She is responsible for UK and EU Quality teams with oversight of Contract Manufacturers/Suppliers/Service providers, the Corporate Audit team, Good Distribution Practice (GDP) policy across Europe, Middle East and North Africa, and Artwork quality related processes.

Caroline Gibbs

Caroline has over 20 years’ experience in the pharmaceutical industry across several companies. In 2013 Caroline moved to QA, taking a role as a QA officer for 3rd party compliance to pursue the journey of QP training. Caroline qualified as a QP in 2015 and since that time has performed Qualified Person duties across both QA operations and Supplier Quality areas in several leadership roles. Currently Caroline is Head of Quality, UK Third Party, QP at Accord-UK Ltd. She and her team provide quality oversight and management of all companies manufacturing, packing, testing liquids, tablets, creams, capsules, ointments, suppositories, medical devices, and some sterile products on behalf of Accord-UK Ltd under their MIA.

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