Teaching Responsibility
LJMU Schools involved in Delivery:
Pharmacy & Biomolecular Sciences
Learning Methods
Lecture
Off Site
Workshop
Module Offerings
6001PHASCI-JAN-CTY
Aims
To cover the philosophy and procedures used in the development, registration and commercial production of pharmaceutical and cosmetic products and the associated regulatory controls to ensure quality, efficacy and safety.
Learning Outcomes
1.
Evaluate the various processes involved in the industrial development and production of pharmaceutical and cosmetic products.
2.
Critically appraise the requirements for product registration and the role of regulatory bodies in the licensing process
3.
Synthesise a coherent proposal for the development of a theoretical product based on existing scientific data
Module Content
Outline Syllabus:Material will be delivered within specified industrially relevant topics, which may be subject to change depending on current staff and external speaker expertise and will focus on contemporary topics of interest. Potential topics include:
Product development and scale-up of manufacturing processes
Quality Control, Good Manufacturing Practice and Quality Assurance
The role of the Qualified Person
Product licensing
The role of regulatory authorities within industry
Regulatory affairs
The International Council on Harmonisation (ICH) process and Quality by design (QbD)
Module Overview:
Within this module, you will gain information relating to pharmaceutical manufacturing processes and the associated regulatory controls to ensure consistency of patient safety.
Within this module, you will gain information relating to pharmaceutical manufacturing processes and the associated regulatory controls to ensure consistency of patient safety.
Additional Information:The Industrial Product Development module will provide undergraduate students with information relating to manufacturing processes and associated regulatory controls within the Pharmaceutical and Cosmetic Industries in order to ensure quality, safety and efficacy. To achieve this a number of aspects will be considered including for example strategies associated with product development and scale-up, the regulation of industrial manufacture and guidelines to ensure appropriate product development.