How much do you really need to know about the ingredients of a medicine?

As a QP, you may not need to be a synthetic chemist or molecular biologist, but there is still plenty you need to know about what goes into your product

After all - Garbage in = Garbage out

  • Key topics

    Regulatory requirements for API and Excipients including

    -Registration of activities
    -Licensing in product dossiers
    -GMP / GDP for human and veterinary products

    Key synthesis routes for chemical and biological entities

    Control measures for impurities, degradation products

    Process validation for APIs

  • Main Tutors

    Greg Webber (In Person)

    Rebecca Rutter (In Person)

    __________________________

  • Included

    Workshops, exercises, assessment

    Leadership for the QP

    Form and viva practice

Learning outcomes

By the end of this module, you will have a broad understanding of the influence of manufacturing pathways, associated physical and physico-chemical attributes of API and Excipients.

  • Common manufacturing steps and the principles of process validation for Chemical and Biological Active Substance

  • Good Manufacturing Practice applicable to Active Substance and Excipients, including controls to prevent / reduce impurities, contamination (including adventitious infection agents e.g. TSE) and control of supply chains

  • The role of the EDQM and Certificates of Suitability
    The role of the Marketing Authorisation Holder in auditing and providing API QP Declarations

  • Physico-chemical and biological properties of Active substance and excipients, the impact of solvents, catalysts and process aids
    The impact on the final dosage form

In this portal

Your materials, assignments and assessments will all be provided through this learning portal

You will be notified by email when items are available for you to access...

  • 1 month before the course start date
    ~ You can access your course workbook
    ~ You will be able to download your Preparatory Assignment

  • Day before course start date
    ~ Downloads for workshops and exercises

  • End of each course day
    ~ Answers to exercises where appropriate

  • After course
    ~ Learning assessment
    ~ Course evaluation
    ~ Certificate

How to find us

Location: Maidstone Innovation Centre
Gidds Pond Way,Weavering, Maidstone, Kent ME14 5FY

Maidstone is very accessible by car, with the M2 and M20 motorways providing easy connections to the M25.

Southeastern run trains across the county and Maidstone town centre benefits from two railway stations. Maidstone East connects to London and Ashford, while Maidstone West links to Gatwick and Tonbridge.
how to find us

Want to know more, find out about the discount bundles available, or book your training

Call us directly on
01622 477781
email us
[email protected]
or pop your email in the box below and we will get right back to you

Thank You