GMP - the essentials with national horizons centre

2 Day/s

CPD Hours: 10


This interactive classroom only course delivered over one and half days at The National Horizons Centre (NHC), which is Teesside University's £22.3m centre of excellence for the biosciences and healthcare sector.

The first day is classroom based theory and day two of the course spent with National Horizons Centre staff completing some practical exercises. This will include a mock deviation investigation using example data and batch manufacturing records – the hope is that delegates will be able to apply the theory they have learnt on the first day of the course to practical problem solving they may encounter in the workplace. The course examines why we have Good Manufacturing Practice (GMP), its legal status and the key GMP issues surrounding pharmaceutical manufacture such as documentation, training and facilities. This informative course introduces the EU Guide to GMP and considers its implementation in the modern pharmaceutical regulatory environment. The course makes extensive use of the facilities available. 

This course is suitable for all pharmaceutical professionals, including newcomers to the industry, who wish to gain a solid knowledge and understanding in the essentials of pharmaceutical GMP.
The following sessions/topics will be covered during the two days training :
  • Expectations of Medicines
  • Why do we have GMP? What’s involved? Includes a Sampling exercise
  • Pharmaceutical Quality System
  • The Orange Guide to GMP
  • Annex II: Biological Substances and Products
  • Personnel Responsibilities
  • Documentation - what are the GMP requirements?
  • Documentation exercise
  • GMP in the warehouse and dispensary
  • GMP in production
  • GMP in packaging
  • Exercise: “Out of Calibration” thermometer
  • Laboratory Exercise at National Horizon Centre on day 2 of the training

    By the end of the course you will be able to:

    • Find your way confidently around the EU Guide to EU GMP and how it is applied in the UK as the Orange Guide
    • Understand the expectations of current Good Manufacturing Practices, and how these can be achieved at a practical level in the manufacture of pharmaceutical products
Course dates TBC
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Special offer

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Meet the tutors

Rob Hughes

Rob Hughes has over 30 years in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. Rob, a practising QP, has experience of the application of QA in many different areas including control laboratories, API, solids, creams and liquids manufacture, and third party audit and evaluation. Rob has many years experience of MHRA and FDA inspections.

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