QP Pharmaceutical Formulation and Processing - Part 2

Comprehensive Formulation and Processing Fundamentals for Qualified Person Certification

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, each three days in duration.  

 

This course provides basic formulation principles, including preformulation studies, bioavailability considerations and the effect of excipients on physical and chemical stability. Each major product category is considered separately 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 key areas that a QP must understand, including process validation and scale-up, facility design, utilities and sterilisation processes. 

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Duration
3 days
CPD Hours
21 hrs
Locations
  • Reading (RSSL)

RSC Logo Approved Training High Res (1)

Who Should Attend

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.  

Course Programme

The course includes the following topics and group exercises: 

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    Preformulation 

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    Water systems 

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    Solution formulation and liquids processing

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    Syrup formulation and processing 

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    Suspension formulation 

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    Topicals and semi-solids 

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    Inhalation products and complaints 

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    Process validation 

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    Utilities 

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    Formulation of sterile products – standard aqueous products and packaging and non-aqueous, lyophilised and biologics products 

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    Processing sterile products – Annex 1 

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    Steam sterilisation and other methods 

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    Autoclaving considerations 

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    Formulation and manufacturing sterile products 

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    Advances Therapies Manufacturing Products (ATMPs) 

Learning Outcomes

By the end of this course, delegates will: 

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    Understand the key pre-formulation data that should be available and the impact of drug properties on product development 

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    Be able to demonstrate familiarity with commonly used excipients and understand the importance of sources and quality on product performance and safety 

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    Have familiarity with formulation and manufacture of the major categories of pharmaceutical products 

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    Understand the factors that can affect content uniformity, stability (physical, chemical and microbiological) and bioavailability 

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    Understand the critical processing techniques, their limitations and critical control parameters 

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    Understand principles of process validation, scale-up and technology transfer 

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    Know how to recognise the potential sources of cross contamination and mix-ups during manufacture of pharmaceutical products 

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    Appreciate issues with storage and transportation of finished products 

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    Be familiar with key annexes in the Orange Guide relating to processing and validating of product 

Peter Deegan (1)

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience. Peter is adept at working with a cross-slice of people to drive a positive ‘Quality Culture’, from shopfloor to boardroom and is passionate about passing on his personal experience to others, through education, coaching, mentoring and training.
Rebecca Rutter (2)

Rebecca Rutter

Rebecca is a highly experienced pharmaceutical professional, eligible to act as a QP under the permanent provisions. She is a recognised subject matter expert in Biotechnology products and ATMPs, with a distinguished career that includes leadership roles at several of the world's most prestigious pharmaceutical companies. Rebecca has a proven track record in establishing and managing greenfield manufacturing facilities, implementing robust processes, optimising supply chains, and delivering critical strategic milestones. Her global expertise includes leading complex remediation activities, ensuring compliance and excellence across diverse regulatory environments.
Frequently asked questions
What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Excellent tutors

Excellent delivery by the tutors and great content with respect to the course materials, which really tackles the subject matter
Anonymous
Curiumpharma Ltd - Employee

Excellent and thorough QP module

Excellent and thorough QP module
Anonymous
ECO animal health - Technical Director

Book Your Place

QP Pharmaceutical Formulation and Processing - Part 2
22 Sep 2025
-
Reading (RSSL)
£2450 excl VAT
Istock 675822682

Bespoke Training

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.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Why choose RSSL?

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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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community