Course Overview

  • “Very good course and experienced tutors.” Ineta Sudmale / JSC Olainfarm, Latvia
  • “Site visits were excellent and really helped put things into ‘real’ application. Buzz Groups were useful and relevant. Very informative, useful and enjoyable.” Helen Neal / Reckitt Benckiser Healthcare, UK
  • “The combination of site tour, presentation, discussions and exercises results in huge learning.” Katja Brodersen / Novo Nordisk, Denmark
  • “I very much enjoyed this course. Very knowledgeable and helpful presenters and valuable discussions. As a non-chemist I particularly found the small molecule API sections very informative - it was pitched at a level I could understand too. I alsoBecky Wildman / Bell’s Healthcare, UK

This course gives a unique insight into the regulatory expectations associated with producing both chemically synthesized APIs and biological/biotech APIs. Delegates will practice interpretation of the key API regulations and see them in operation during visits to two API manufacturing facilities. 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. The course also provides insight and expertise on managing global API supply chains, vendor quality assurance and “how to audit” API facilities.

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.

It provides 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
  • How to audit and provide QA of excipients
  • How to manage change of API source
  • How to compare the requirements of chemically synthesized APIs and biotech products
  • How to audit and how to provide oversight of remote or contract manufacturing capabilities

It 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.

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

Course Content

For both chemically 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
  • Common sources of GMP non-conformance and adulteration or misbranding
  • Vendor assurance, management of supply chains and auditing of facilities by QA or QPs – scope, execution and follow-up of audits
  • Two visits to state-of-the-art facilities and discussions with on-site pharma professionals (API and Biotech)

We provide an optional post-course assessment.

Course Outline

Active Pharmaceutical Ingredients

  • The regulations
    • EU and US 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 validation
  • Supply issues for the dosage form manufacturer
    • Supplier selection and audit
    • Supply chain integrity
    • Technical 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 guidances/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.
  • As well as being accepted in the UK, our training courses are well known and accepted by several other 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 the 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.

Find out why you should choose NSF for your QP training by visiting our qualified person training section

Course Tutors

  • John Johnson -Vice President at NSF, John has vast experience in preparing sites for regulatory GMP inspections, preparing or remodelling biopharma and steriles facilities, installing quality systems and helping companies embed the right culture for long term sustainable growth. A passionate educator, John has a track record of improving service, improving margin and ensuring perpetual GMP inspection readiness.
  • Roger Guest Roger has held senior roles within R&D, manufacturing and QA with several blue-chip pharma and biotech companies. He has been responsible for the design and implementation of new sterile manufacturing facilities and has extensive experience of the development of IMPs and biologicals from formulation to manufacture.

Other dates and venues for this course

Course Fees

Course cost (excluding VAT)  £2,880.00


Multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators, charities and some self-funding individuals – contact us for details.

Have a question or want to book a place? Contact - you can also register online by clicking below.