Active Pharmaceutical Ingredients - QP Module

NSF International, Pharmaceutical Services
Course summary
4.5 days
2,290 GBP excl. VAT
Next available date: 01/06/2020 08:30 - Durham

Course description

Active Pharmaceutical Ingredients

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 APIs. Delegates will practice interpretation of the key API regulations and see them in operation during visits to two API manufacturing facilities. The course also provides insight and expertise on managing global API supply chains, vendor quality assurance and “how to audit” API 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.

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

*All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Suitability - 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.

Outcome / Qualification etc.

Key Learning Objectives

  • To manage risk across a range of API processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern
  • Provides practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration
  • How to meet 2004/27/EC
  • How to manage change of API source
  • How to audit and how to provide oversight of remote or contract manufacturing capabilities

Training Course Content

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


Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

pharma training courses

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...

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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
YO62 6AF York


Ineta Sudmale, JSC Olainfarm, Latvia
Very good course and experienced tutors.
Helen Neal, Reckitt Benckiser Healthcare, UK
Site visits were excellent and really helped put things into ‘real’ application. Buzz Groups were useful and relevant. Very informative, useful and enjoyable.
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