Microbiological Quality Control

This module is designed to give learners a clear understanding of the role of microbiological quality assurance and quality control, particularly as applied to the (bio)pharmaceutical and medical device sectors.

It will provide learners with the information and laboratory skills to enable them to recognise the role of the microbiologist in the production of safe and wholesome products and to participate effectively in Quality Assurance teams in industry.

It will equip learners with the skills necessary to design appropriate QC testing protocols for raw materials, waters, in-process and finished products.  Learners should be able to adopt an advisory role in situations relating to Microbiological Quality Control by recommending suitable materials, equipment and procedures. ‘Laboratory practical’s will be delivered/rolled out to students with a lecturer led emphasis on sustainability. Students will be asked to reflect on how they may incorporate sustainability into their practical work when preparing their laboratory reports’. ​

Learners will have gained sufficient knowledge of the microbiology of pharmaceutical and healthcare products to enable them to take up responsible positions in QA and QC in Industry.

1. Describe potential microbial contamination problems which would compromise the wholesomeness and safety of Pharmaceutical and Healthcare products.

2. Define the role of the microbiologist in the implementation of appropriate Quality Assurance (QA) and Quality Control (QC) programmes.

3. Identify potential sources of microbial contamination in industry.

4. Assess specific microbiological problems associated with ‘water for pharmaceutical purposes' and monitor such water.

5. Construct appropriate microbiological QC testing protocols for raw materials, waters, in-process and finished products.

6. Plan and undertake pharmacopoeial 'microbial limits tests'.

7. Perform total cell counts and viable counts, using a broad range of analytical techniques.