Good Manufacturing Practice – Essentials

Duration: 1.5 days
Price: £1,299+VAT

Delivered in partnership with RSSL this interactive 1½ day 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. Delegates will be introduced to the EU Guide to GMP and considers its implementation in the modern pharmaceutical regulatory environment.

    Training partners

  • RSSL

The course programme will include expectations of medicines, the purpose of GMP, pharmaceutical quality systems, the EU guide to GMP and the US CFRs, roles of key personnel and their departments, documentation requirements, GMP in the warehouse and dispensary, GMP in production and packaging, people and training, and an introduction to deviations.
Module 1

o Expectations of medicines
o Why do we have GMP? What’s involved?
o Sampling exercise
o Pharmaceutical quality system
o The Orange Guide to GMP
o Annex II: Biological substances and products
o Personnel responsibilities
o Documentation - what are the GMP requirements?
o Exercise: Documentation
o GMP in the warehouse and dispensary
o GMP in production
o GMP in packaging
o Exercise: Out of calibration
o What have we learned?

Module 2

o Batch Deviation Exercise – delegates to apply their understanding of GMP compliance to a mock deviation investigation - using example data and batch manufacturing records. Delegates will have the chance to apply their problem-solving skills to a scenario they may encounter in the workplace

Learning outcomes:

  • 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.

Who should attend:

  • 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

Course dates

More dates coming soon

For enquiries and details of the full agenda please email CPDNHC@tees.ac.uk

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