QP pharmaceutical formulation and processing - part 2

3 Day/s

CPD Hours: 21

Classroom, online, in-house

RSC approved

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. Part one of the course includes a practical day to gain hands-on experience in the preparation and evaluation of some formulations.

RSC Logo Approved Training High Res (1)

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
    • Preformulation
    • Water Systems
    • Solution Formulation & Liquids Processing
    • Syrup Formulation & Processing
    • Suspension Formulation
    • Solutions & Suspension
    • Topicals & Semi-solids
  • Day 2
    • Inhalation Products
    • Process Validation
    • Formulation of Sterile Products – Part 1 (Standard Aqueous Products & packaging)
    • Utilities
    • Formulation of Sterile Products – Part 2 (Non-aqueous, Lyophilised and Biologics Products)
  • Day 3
    • Processing Sterile Products – Annex 1
    • Annex 1 comparison
    • Steam Sterilisation
    • Autoclaving Considerations
    • Other Methods of Sterilisation
    • Manufacturing Sterile Products
    • Sterile Products Formulation & Manufacturing

    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

Neil Wayman

Neil is a Microbiologist with over 30 years experience in the pharmaceutical industry. Neil Treasurer of the Pharmaceutical Quality Group and actively involved in running the annual MHRA/PQG meeting. In 2012 he moved back to a role as QA Group manager, QP and RP on the license at AstraZeneca’s second largest manufacturing site at Macclesfield in Cheshire with primary responsible for the site QMS, internal and external inspections, licensing, issue management and recall. In 2018 he moved to AstraZeneca Corporate Quality as Global Quality Director primarily responsible as Global Business Process Owner for Complaints.

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 1

First part of the six day formulation and processing course