Program Overview

Module Information

Module Goal

To provide students with an introduction to the formulation and regulatory requirements for the manufacture of pharmaceutical dosage forms and how those requirements influence the safety, quality and efficacy of the pharmaceutical products.

Module Content

An overview of therapeutic agents - from small to large molecules and biologics. Pharmaceutical formulations and routes of delivery. Unit processes involved in the production of drug substances and dosage forms. Practical aspects and applications in the processing and control of sterile pharmaceutical products. Registration and licensing requirements for new medicinal products and facilities. An overview of cGMP requirements in the regulations. Design and validation of pharmaceutical processes.

Additional Teaching Mode Information

• 24 x 0.5hr(s) lectures
• 8 X 1hr(s) webinars

Assessment and Evaluation

Continuous Assessment - 200 marks

• Canvas Quiz - 2 x 40 marks (80 marks)
• 2000 word written assignment - 2 x 60 marks (120 marks)

Program Learning Outcomes

On successful completion of this module, students should be able to:

• Describe the formulations and routes of delivery appropriate for different therapeutic agents.
• Explain unit operations involved in the production of drug molecules and how they affect the product quality attributes.
• Evaluate how current regulatory practices ensure the quality, safety and efficacy of the pharmaceutical drug products.
• Discuss how the GxP principles are integrated within the quality management system of pharmaceutical organizations.
• Discuss the lifecycle approach of the pharmaceutical process validation.

Admissions and Eligibility

Requirements

Science, engineering and healthcare graduates who hold a NFQ Level 8 qualification and who wish to receive targeted upskilling in the pharmaceutical and biopharmaceutical sectors. Provision will also be made for candidates who hold sufficient previous educational/professional experience.

Fees and Costs

Fees

The fee for this micro-credential is €1,250 but applicants who meet the subsidy requirements can attend this micro-credential for €625.

Key Dates

Closing Date

21/12/2025

Start Date

January 2026

Program Details

Credits

10

NFQ Level

Level 9

Duration

8 weeks

Teaching Mode

Part-Time

Updated

17 Jul 2025