Active Substances and Excipients Training


July 3 – 7, 2023

Durham, United Kingdom

5 days


About This Course

This active pharmaceutical ingredients (API) training course gives a unique insight into the regulatory expectations associated with producing both chemically synthesized APIs and biological/biotech API’s. The course also provides insight and expertise on managing global API supply chains, vendor quality assurance and “how to audit” API facilities. We summarise the key steps in identifying and removing impurities, including some updated information on the impact of potential nitrosamine formation in API processes.

This course fulfils the requirements of the Qualified Person Study Guide and we don’t just train to pass a viva, we take the time to prepare you for your career ahead.

This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.

Key Learning Objectives

As API supply chains become ever more diverse and cost pressures more acute, the pharma manager needs a keen appreciation of risk factors, design, control and monitoring of API sources. This course allows delegates to differentiate between natural variation and risk across a range of API processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.

You will be provided with an overview of the regulatory framework surrounding active pharmaceutical manufacturing process and be given practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration.

You will also learn:

  • How to meet 2004/27/EC
  • The major differences between chemical synthesis and bioprocesses; and contrasting both against drug product formulation
  • How to manage change of API source
  • How to audit and provide QA oversight of excipients
  • How to audit and how to provide oversight of remote or contract manufacturing capabilities

The course will also allow you to make informed decisions when faced with a range of GMP non-conformances during API synthesis.

Our detailed educational material grows into a lifelong reference library.

Course Content

For chemically synthesized and biologically produced APIs, the course includes:

  • Common process steps and their effect on the quality of the final drug substance
  • EU and US regulatory requirements
  • Comparison and contrast of API facilities
  • How GMP is implemented across the key production processes from API starting materials through to packaging and distribution
  • Common sources of GMP non-conformance and adulteration or misbranding
  • Vendor assurance and management of supply chains including auditing of facilities

Course Outline

Active Pharmaceutical Ingredients

  • The regulations
    • EU and U.S. regulations and guidelines
    • Drug master files and certificates of suitability
    • Key GMP guidance – ICH Q7
  • Manufacturing processes and quality
    • Key issues for:
      • Synthesis
      • Purification and impurity control
      • Packaging
    • Process qualification/validation
  • Supply issues for the dosage form manufacturer
    • Supplier selection and audit
    • Supply chain integrity
    • Technical/quality agreements
    • Certificates of analysis

Bulk Biologicals and Biotech Products

  • What is a biological or biotech product?
  • EU and US regulatory aspects
  • Essential characteristics of biologicals
    • Antibiotics
    • Vaccines
    • Blood products
    • Monoclonal antibodies
  • Quality aspects
    • Control of starting materials
    • Control of cultivation, harvest and purification
    • Analytical and bioassay techniques


  • Regulatory environment
  • GMP guidance’s/codes

Who Should Attend

The Aspiring Qualified Person

  • Our training is generally considered as the best available and our QPs are held in high regard within the industry.
  • In addition to being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional

  • Not all people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
  • Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

Course Tutors

Course tutors will be selected from the following:

Kate Krachai – Kate is eligible to act as a QP. She has over 20 years’ experience in the pharmaceutical industry across key positions in quality management and as a pharma lead auditor. Kate has extensive experience in pharmaceutical development, manufacture and supply of marketed and investigational medicinal products (IMPs) and the associated pharma quality system.

David Waddington – David’s career in the pharmaceutical industry spans more than 30 years in various quality roles for three major international pharmaceutical organizations. Dave is eligible to act as a Qualified Person under the permanent provisions. He has broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for global supply, including solids, liquids, sterile products, food supplements and natural products.


Multi-delegate discounts available. Discounts also offered to NHS staff and charities.