Course Scope
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 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 practise 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.
Learning Outcomes
By the end of the course you will be able to:
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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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Demonstrate familiarity with commonly used excipients and understand the importance of sources and quality on product performance and safety
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Demonstrate 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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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 products.
