Pharmaceutical product development, GMP requirements

2 Day/s

CPD Hours: 14

Classroom, online, in-house

The development of Pharmaceutical Products typically takes years and costs significant amounts of money.


Pressures to get products to the market are ever increasing so working in a well- controlled, compliant manner during all phases of development is essential if market approval of a product is to be achieved. Although there is some guidance available, often those involved are unsure of how much “GMP” is required and when it is required. Once Investigational Medicinal Product (IMP) manufacture has been initiated, it becomes a little easier, however there are still some flexibilities allowed depending on the phase of the clinical trials involved. There is therefore a need for some practical GMP guidance for these important stages of the product lifecycle and sharing of experiences.

The course is suitable for any person working in QA or QC plus Formulation Scientists and Regulatory Affairs personnel plus those looking after the premises, utilities and equipment. In addition, those starting out working in this field and those who even if they have worked in this field for some time, have little or no understanding of the GMP expectations for these activities. It could also be of benefit for trainee QPs who do not work in this field and have little understanding of the challenges involved.
The course covers the following topics:


  • Legislation and guidelines available
  • Specific GMP expectations for IMP manufacture
  • How to handle “events” arising during manufacture or testing
  • Management of raw/starting materials and suppliers
  • Documentation expectations during product development
  • Data integrity – what is expected?
  • Overview of analytical method development requirements
  • Overview of stability study requirements
  • Role of the QP in development and for IMP manufacture
  • Management of outsourced activities
  • Inter relationship between GMP/GDP and GCP
  • Packaging and supply of Clinical Trial (CT) materials

    By the end of the course, you will :


    • Understand the development stages for a pharmaceutical product and what is involved
    • Aware of the legislation and guidelines that are relevant for development and IMP manufacturing/supply activities
    • Understand some of the practical GMP challenges that face those working in this field and how these are managed
    • Feel more confident when interacting with colleagues in other disciplines
    • As trainee QPs, gain an awareness of product development and IMP manufacture
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Meet the tutors

Sue Mann

Sue has worked in the industry for over 38 years, principally in quality and technical roles. She has a wealth of experience having held European Director & VP level positions at companies such as Eisai and Shire. For the last 11 years, Sue has been an independent consultant providing services across all major dosage forms and more recently ATMPs.

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