QP Pharmaceutical Formulation and Processing - Part 1 with Practical Day

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3 Day/s

CPD Hours: 21

Classroom

The Qualified Person should have a thorough knowledge of formulation and processing of the medicinal products they are asked to certify.


This six-day (two part) module 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 includes exercises on typical situations for the trainee QP to practice decision-making. Sessions on other key areas that a QP must understand including process validation and scale-up, facility design, utilities and sterilisation processes are included.

There are two versions of this course, a two day course (run in February/March) and a three day course (run in June/July). The three day course includes a practical day to gain hands-on experience in the preparation and evaluation of some formulations. If you do not need the practical day because you have enough hands-on formulation experience you may be better suited to our February course.



Classroom courses - please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.


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 no prior or a basic knowledge of the subject however would be of benefit to the more experienced.
The course includes the following topics and reinforced using group exercises :

Day 1


  • Introduction to Formulation
  • Dosage Forms & Routes of Administration
  • Introduction to Formulation continued (Bioavailability/ Pharmacokinetics)
  • Raw Materials in Pharmaceutical Products
  • Preformulation 1 (Solid State Properties)
  • Particle Size and Particle Size Analysis
  • Powder Mixing & Direct Compression
  • Blending
  • Granulation (wet granulation)
  • Drying & Milling
  • Questions on Granulation, Drying & Milling
  • Granulation (Dry Granulation)

Day 2


  • Lubrication & Compression
  • Tablet Processing
  • General Aspects of Solid Dosage Forms
  • Hard Gel Capsules
  • Tablet Coating
  • Solid Dose Modified Release Products
  • Soft Gel Capsules
  • Solid Dose Forms

Day 3


  • Practical laboratory day includes, preparation and evaluation of some formulations

    By the end of the course you will be able to:

    • Understand the key pre-formulation data that should be available and the impact of drug properties on product development
    • Demonstrate familiarity with commonly used excipients and understand the importance of sources and quality on product performance and safety
    • Demonstrate 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
    • 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.

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Meet the tutors

Elena Kabova

Elena is a Lecturer in Pharmaceutical Chemistry (Teaching and Research) at the University of Reading, specialising in Pharmaceutical Chemistry and Pharmaceutics. Elena graduated with a first class honours degree in Chemistry and then a PhD in Pharmacy.

Rebecca Rutter

Rebecca is a Qualified Person and Responsible Person (Eligible to act as a Qualified Person under the permanent provisions) with expertise with Biotechnology products and provision of support for Advanced Therapy Medicinal Products (ATMP). She has held Director positions at some of the most prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.

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QP pharmaceutical formulation and processing - part 2

Part two of the QP formulation and processing module continuing the insights you'll need in order to gain the thorough knowledge of the medicinal products you will be asked to certify