QP investigational medicinal products

2 Day/s

CPD Hours: 14

Classroom, online, in-house, eLearning

RSC approved

All QPs need to understand the different Good Manufacturing Practice (GMP) requirements for commercial and Investigational Medicinal Products (IMPs), and the unique additional GMP requirements for IMPs. This two day interactive course examines the EU legislation relevant to the manufacture, control and supply of IMPs. It provides practical guidance on the major differences in the GMP requirements between IMPs and commercial products, and the unique areas that QPs need to consider when releasing IMPs e.g. packaging and labelling processes and control.

Delegates will also benefit from the opportunity to learn about the principles of Good Clinical and Good Laboratory Practice, and how these relate to GMP for IMPs.

This course now has an optional eLearning Knowledge Reinforcement Module available for delegates to purchase at £170. The eLearning module reviews 5 key topics from the tutor led course and has 72 questions, to test your knowledge and ensure you know the subject matter ready for your Viva.

RSC Logo Approved Training High Res (1)

The course is ideally suited for those wishing to ensure they have sufficient awareness of the specific nature of IMPs and the challenges facing the QP, and is suitable for QPs, Production and QA Staff working in IMP manufacture and supply.

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

  • Day 1
    • Methods and Equipment including Virtual Tour of Chemical facilities
    • Methods and Equipment for Bio APIs
    • GMP Requirements for API’s-Eudralex Vol 4
    • GMP Requirements FMD and GDP
    • GMP Requirements ICH and Impurities
    • MCQ on Part II
  • Day 2
    • Registration Aspects including QP declaration
    • Laboratory Controls
    • Process validation overview
    • Cleaning validation overview
    • Understanding the Supply Chain and QP Responsibilities
    • The Control of API Packaging Materials
    • API Audit Situations

    At the end of the course you will:

    • Understand the requirements of Directives 2001/20/EC and 2005/28/EC
    • Appreciate the unique nature of many aspects of IMP manufacture
    • Be aware of the GMPs relevant to IMPs – including Annex 13
    • Be aware of the principles of GCP and GLP and how these relate to IMP manufacture
Book your place
Select Date & Location

ex VAT

Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Jane Wright

Jane has over 30-years’ experience in quality assurance roles, including Quality Management positions and, encompassing a wide range of dosage forms. Dosage form experience includes metered dose inhalers, tablets, capsules, liquids, topical preparations, plus sterile products.

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.

Related Course

Istock 1355977307

Good clinical practice for ATMPs

Provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP) specific to ATMPs.