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.
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.
This module reviews eight key sections from the course to test your knowledge.
QP module - RSC approved training
Learn qualitative and quantitative methods, in addition to method selection and validation.
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.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
