About This Course

This active pharmaceutical ingredients (API) training course gives a unique insight into the regulatory expectations associated with producing chemically synthesized APIs. Delegates will practice interpretation of the key API regulations and see them in operation during a visit to a commercial API manufacturing facility. The course also provides insight and expertise on managing global API supply chains, vendor quality assurance and “how to audit” API facilities. Featured for 2020, we summarise the key steps in identifying and removing impurities, including some updated information on the impact of potential nitrosamine formation in API processes (a key genotoxic impurity that has led to multiple global recalls this past year).

If you need a similar introduction to APIs derived from biotech, biological or ATMP routes, please access our Biotech and ATMPs course that focusses on bio drug substances.

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 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, management of supply chains and auditing of facilities by QA or QPs – scope, execution and follow-up of audits
  • Visit to state-of-the-art facilities and discussions with on-site pharma professionals

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 validation
  • Supply issues for the dosage form manufacturer
    • Supplier selection and audit
    • Supply chain integrity
    • Technical agreements
    • Certificates of analysis

Excipients

  • 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.
  • 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:

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.

John Johnson - 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 and margin to ensure perpetual GMP inspection readiness.

Kevin Mackenzie - Kevin has 40 years’ experience in the pharmaceutical industry and has held a number of key positions within quality, most recently as Head of Global Supplier Audit & Compliance. Much of his career has been in API manufacturing, supporting technology transfer and sourcing programs. He has performed audits and technical visits in over 40 countries. Kevin’s areas of expertise include API manufacture, supplier quality management processes, inspection preparation and remediation, auditing and pharmaceutical quality systems.

Discounts

Multi-delegate discounts available. Discounts also offered to NSF staff, regulators and charities.