QP Active Pharmaceutical Ingredients
The Qualified Person (QP) must understand the influence of manufacturing pathways and associated physical and physico-chemical attributes of both active pharmaceutical ingredients and major excipients on the quality of the finished dosage form.
Certification of the finished medicinal product by a QP relies on the assurance of active substances, excipients and packaging materials, as well as the control of the supply chain.
With the specific responsibility of assuring the quality of the active substances used in the finished medicinal product, the QP must sign a declaration of compliance with GMP for initial product registration and subsequent variations. The QP must have assurance that the active substance has been transported under appropriate GDP conditions and meets the importation requirements laid down in the Falsified Medicines Directive (FMD) and by the UK MHRA.
This course includes the technical aspects of the manufacture of active substances, GMP requirements for active substances and excipients, the different routes for registration of active substances and the relationship with other relevant standards including the European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability (CEP) and International Council for Harmonisation (ICH) guidelines.
Interested in QP training for your team? Contact us today.
This is an essential course for all those who are undergoing QP training and expect to be undertaking the QP VIVA. It is also an extremely useful refresher and useful for Continuing Professional Development for current QPs. The course is also suitable for those who need an understanding of the requirements for active substance manufacture and supply, including those working in purchasing, quality assurance, manufacturing or regulatory affairs.
This course covers the following topics:
The responsibilities of the QP, including the preparation of the QP declaration of GMP compliance for active substances
Manufacturing methods and equipment including virtual tour of facilities used to manufacture active substances by chemical synthesis or biological active substances
Control of sources and levels of degradants, impurities and adventitious agents, including relationship with relevant ICH guidelines
Control and assurance of sterility for sterile active substances
Overview and application of Eudralex Volume 4/Orange Guide Part II: Basic Requirements for Active Substances used as Starting Materials and relevant elements of Part I.
Good Distribution Practice (GDP) for active substances
Falsified Medicines Directive and the verification and the control of the supply chain and importation
The alternative routes for registration of active substances including Marketing Authorisation, Active Substance Master File (ASMF) and EDQM CEP
The laboratory controls applied in the analysis and testing of active substances and excipients, including the application of the EDQM CEP process
Process validation of active substance manufactured by chemical synthesis and biological active substances
Impact of the quality of active substances and excipients in the finished dosage form
The requirements for cleaning validation and potential impact of inadequate cleaning
The control and assurance of active substance supply chain
The control of packaging materials for the storage and transportation of active substances
Auditing of the active substance supply chain and the interpretation of active substance observations
At the end of the course you will know the:
Role and responsibilities of the QP regarding active substance manufacture and supply
Methods and equipment used in active substances manufactured by chemical synthesis and biological methods
Regulatory framework for the manufacture and supply of active substances
Requirements of the Falsified Medicines Directive for active substances
GMP requirements for active substances and excipients
Principles for the management and control of active substance and excipient supply chains including the QP declaration and application of EDQM CEP
Processes for registration of active substances and structure of registration contents
Requirements for specifications, organic solvents, impurities and adventitious agents
Principles of process and cleaning validation applied to active substances
The control of packaging materials for active substances
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If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.
Yes, QP Trainee packages are available with RSSL and include a number of exclusive benefits. Contact our QP Training Advisor to learn more on trainingsales@rssl.com or by calling +44 (0)118 918 4000, and join our upcoming webinar, 'To QP or not to QP?', designed for aspiring QPs.
Yes, the QP API course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details.
Places will be available for you to book unless it states ‘Full’ next to your chosen QP API course date. When this occurs, we operate a waiting list service.
Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems.
You will need to first register yourself on our booking system by selecting the QP API course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the QP API course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included.
Yes, this QP Active Ingredients course is available in-person or virtually on the Adobe Connect training platform. If a venue is listed against your preferred course date, then this course is scheduled as an in-person session.
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you.
Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address.
Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system.
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
Please see our 'minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test.
Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.
All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.
Our classroom courses are fully catered, and we provide all refreshments. If you have any special dietary requirements, please enter these into the ‘dietary requirements’ field when creating your account. Our virtual tutor-led courses will include a 45-minute lunch break.
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We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
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