Teaching Responsibility

LJMU Schools involved in Delivery:

Pharmacy & Biomolecular Sciences

Learning Methods

Lecture
Off Site
Workshop

Module Offerings

6001PHASCI-JAN-MTP

Aims

To present information relating to pharmaceutical manufacturing processes and the associated regulatory controls to ensure consistency of patient 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 6 specified industrially relevant topics, which may be subject to change depending on current staff expertise and will focus on topical delivery systems of current interest. Potential topics include:

1. Formulation development and scale-up of pharmaceutical manufacturing processes
2. The structure of a pharmaceutical company
3. GMP, Quality Assurance and the role of the Qualified Person
4. Pharmaceutical product licensing
5. The role of regulatory authorities within the Pharmaceutical Industry
6. The International Conference on Harmonisation (ICH) process
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.
Additional Information:
The Industrial Drug Development module will provide undergraduate students with
information relating to manufacturing processes and associated regulatory controls
within the Pharmaceutical Industry in order to ensure the consistency of patient
safety. To achieve this a number of aspects will be considered including for example
strategies associated with formulation development and material scale-up,
organisational aspects within the Pharmaceutical Industry, the regulation of
pharmaceutical manufacture and guidelines to ensure appropriate formulation
development.

The requirement for professional behaviour within the Pharmaceutical Industry will be underscored throughout the module.  A competency in this field will not be assessed.

Assessments

Presentation
Centralised Exam