QP Module 5: Active Pharmaceutical Ingredients
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The quality of a medicine depends in no small part on the quality of its ingredients, and in particular the active
Dates:
Monday 08 to Thursday 11 September 2025
Venue:
Newcastle Marriott Gosforth Park, Newcastle, UK
Cost:
£2560.00 excl. VAT - £3072.00 incl. VAT
(2nd delegate bookings from the same company and same site will receive a 20% discount on the course fee)
Type: Pharmaceutical
About this course
The quality of a medicine depends in no small part on the quality of its ingredients, and in particular the active.
Thus, the Qualified Person and other key professionals in dosage form manufacture must have a thorough understanding of how the manufacture and control of the active and its supply chain may influence the fitness for use of the finished product.
This is recognised by the regulators, especially in Europe where the adoption of Directive 2004/27/EC has put the responsibility for assuring the quality of the active firmly on the shoulders of the dosage form manufacturer, with certain expectations specifically for the QP.
This course is designed to provide you with the knowledge and understanding to fulfil your responsibilities with competence and confidence.
Why This Training Will Benefit YOU
The Aspiring Qualified Person
- This series of 12 modules held over a 21 month period has been carefully designed to meet the requirements for theoretical training detailed in the latest UK Qualified Person Study Guide and EC Directives 2001/82/EC and 2001/83/EC.
- All our training courses provide practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges that lie ahead.
- 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.
- Increasingly, companies are using these modules as part of a modular technical and professional development plan for their staff.
- Additionally, many industry professionals attend the courses as part of their Continuing Professional Development.
- This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator, at [email protected] for more information
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?
- EU and US Regulatory Aspects
- Essential Characteristics of Biologicals
- Antibiotics
- Vaccines
- Blood products
- Monoclonal antibodies
- Recombinant DNA products
- Quality Aspects
- Control of starting materials
- Control of cultivation and purification
- Analytical techniques to judge quality
Excipients
- Regulatory Environment
- GMP Guidances/Codes
Manufacturing Site Visits
The course will include visits to state-of-the-art API manufacturing facilities in the area in order to put into practical perspective the key issues discussed in the lectures.
Discussion and Working Groups:
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific question and concerns.
Venue
Newcastle Marriott Gosforth Park, Newcastle, UK
Set on 12 acres of parkland near Newcastle City Center and Newcastle International Airport, the Newcastle Marriott Hotel Gosforth Park offers the ideal setting.
The Newcastle hotel’s beautifully renovated guest rooms have high-speed internet access. The Hotel also has an impressive range of leisure facilities includeding a well-equipped gym, tennis courts, pool, sauna and squash courts. You can also pamper yourself at the spa located inside the hotel.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which will be provided to you on receipt of a completed booking form.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Newcastle Marriott Gosforth Park
High Gosforth Park
Newcastle upon Tyne, NE3 5HN
England
Tel: +44 (0) 191 236 4111
Fax: +44 (0) 191 236 8192
www.marriott.com
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
“It was a very good summary of API expectations. Being an API manufacturer, it was important for me to know the QP expectations. The course fully met my requirements. Thank you!”
Edit Berezvai, Sanofi-Aventis-Chinoin, Hungary
“It was very nice to visit an API plant and match the lectures with the real-life situation. The buzz group about planning/content for an audit was very helpful for my further tasks at the company.”
Leen van de Water, Pannoc, Belgium
“Course was beneficial in gaining a better understanding of the expectations a QP/customer would have regarding an API supplier and the areas/systems/standards required, particularly as I am working for an API manufacturer. The course was also beneficial in providing an overview of the regulation of APIs which I personally wouldn’t have much dealings with on a day to day basis.”
Evan McCarthy, Novartis Ringaskiddy, Republic of Ireland
An NSF International Company 
