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Active Pharmaceutical Ingredients - QP Module

NSF International, Pharmaceutical Services
Course summary
4.5 days
2,960 GBP excl. VAT
Full time
Next available date: 26/10/2020 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

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

Why choose NSF International, Pharmaceutical Services

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

Provided expert pharmaceutical training for over 30 years

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


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

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About provider

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


Average rating 5

Based on 5 reviews

A. Hume
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 experience as fulfilling as possible. Very grateful for the opportunity to visit, these sites are very different from my own but give me a much better understanding.
G. Clarke
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. This work was an excellent overview of both, the plant tours were hugely helpful and interesting and all tutors were engaging and very knowledgable.
A. Costa
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 opportunities to the trainee QPs, keep it up!
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Based on 5 reviews
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