QP Pharmaceutical Formulation and Processing - Part 1 with Practical Day
The Qualified Person should have a thorough knowledge of formulation and processing of the medicinal products they are asked to certify. The comprehensive six-day course is split into two parts, with Part 1 focusing on foundational formulation principles.
Attendees will gain an understanding of preformulation studies, bioavailability considerations and the effects of excipients on physical and chemical stability. Each major product category is covered in detail, with respect to common formulations and processing techniques.
The course also includes practical exercises on typical situations, allowing trainee QPs to enhance their decision-making skills using real life scenarios. Sessions will also focus on other key areas that a QP must understand including process validation and scale-up, facility design, utilities and sterilisation processes.
On the last day, attendees will take part in a hands-on practical laboratory day, where they will prepare and evaluate various formulations.
This is a crucial module for QPs who are, or who will be involved in certifying commercial or investigational batches of medicinal products. The course is most suitable for delegates with little or no prior knowledge of the subject, although it also offers valuable insights for more experienced professionals.
The course includes the following topics and group exercises:
Introduction to formulation
Raw materials in pharmaceutical products
Preformulation
Particle size and analysis
Powder mixing and direct compression
Granulation, drying and milling
Lubrication and compression
General aspects of solid dose forms
Hard and soft gel capsules
Tablet coating
Oral modified release
Preparation and evaluation of formulations
By the end of the course, delegates will:
Understand the key pre-formulation data that should be available and the impact of drug properties on product development
Be able to demonstrate familiarity with commonly used excipients and understand the importance of sources and quality on product performance and safety
Have familiarity with formulation and manufacture of the major categories of pharmaceutical products
Understand the factors that can affect content uniformity, stability (physical, chemical and microbiological) and bioavailability
Understand the critical processing techniques, their limitations and critical control parameters
Understand principles of process validation, scale-up and technology transfer
Be able to recognise the potential sources of cross contamination and mix-ups during manufacture of pharmaceutical products
Appreciate issues with storage and transportation of finished products
Be familiar with key annexes in the Orange Guide relating to processing and validating of products.
Know how to prepare and evaluate some of the relevant formulations through practical laboratory experience
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
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.
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.
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
