Professional Training
5.0 (5 Reviews)

Active Substances & Excipients

NSF International, Health Sciences, In Durham (+1 locations)
4.5-5 days
2,100 - 2,960 GBP excl. VAT
Next course start
Enquire for more information (+2 start dates)
Course delivery
Classroom, Virtual Classroom
4.5-5 days
2,100 - 2,960 GBP excl. VAT
Next course start
Enquire for more information (+2 start dates)
Course delivery
Classroom, Virtual Classroom
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Course description

Active Substances & Excipients

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 dont 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.

Upcoming start dates

Choose between 2 start dates

Enquire for more information

  • Classroom
  • Durham

Enquire for more information

  • Virtual Classroom
  • Online

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.

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.

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


  • Regulatory environment
  • GMP guidances/codes

Course delivery details

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.

Why choose NSF International, Health Sciences

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert health sciences training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

Customer Outreach Award


We believe that it should be easy for you to find and compare training courses. 

Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.


Average rating 5

Based on 5 reviews.
Reviews are published according to our review policy.
Write a review!
A. Hume
14 Jun 2019
Enjoyable course

Very enjoyable course - tutors excellent. The site visits were great. Two very different sites but each great hosts, open and honest with a view to making our learning experienc...

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G. Clarke
29 Jun 2018
More than met my requirements

The training more than met my requirements. I had no previous experiences if other small molecule synthesis or biopharmaceutical manufacture and only limited knowledge of either...

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A. Costa
29 Jun 2018
Enjoyable module

Truly enjoyable module where tutors went the extra mile to show experiences, deliver additional lectures, and change the programme to give the best possible educational opportun...

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

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