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.

An introductory course on applicable GMPs to be applied during Pharmaceutical Product Development including IMP manufacture for Pharmaceutical professionals working in the industry, NHS or academic institutions, wanting to learn about some of the differences and challenges associated with the development process and how to ensure compliance with relevant GMPs.

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 run her own consultancy since 2009 and works with companies all around the world. She became a QP in the mid 1980’s and a QP Assessor in the early 2000’s. Although her core knowledge and experience is in GMP, she has built up knowledge and experience in Good Distribution Practice (GDP) and has helped write a guidance document published by PQG and ECA which expands upon the EU GDP Guideline. Sue has dealt with many GMP systems in her over 40 years’ experience in the industry; including WHO whilst involved in a development project in a number of African countries, funded by UNIDO. Sue has been a QP for many years and understands the complexity of the role and its position within a company. She is an inspiring trainer being able to break down complex topics into understandable sections and can “train” at all levels in an organisation. She understands what it is that is important in fulfilling the role of a QP.

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