MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details
Year of entry: 2021
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Course unit details:
Quality Assurance in Microbiology Laboratories (PMAT 5)
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Variable teaching patterns|
|Available as a free choice unit?||No|
Principles, concepts and references used in the QA, QC, GMP and GLP of the microbiology laboratory will be covered in more detail here. The laboratory facility, equipment and consumables used along with the validation of processes, equipment and methods will also be covered.
There will also be a more detailed look at quality audits and training issues, together with the documentation control required will be detailed. The management of microbiology laboratory customers will be explained.
The unit aims to:
- provide a good understanding of GMP required for a pharmaceutical microbiology laboratory;
- give a good overview of the main principles of GMP and the differences between QA and QC;
- provide a good understanding of the application of aspects of quality management systems that are applicable to the microbiology laboratory, for example validation, training and documentation standards.
Teaching and learning methods
Students are provided with the learning material in soft copy form. The learning material comprises 12 chapters covering the key areas of quality assurance in laboratories, including microbiology laboratories. Each chapter contains a number of exercises for students to check their learning as they progress through the unit. A reference list of further reading is provided at the end of the unit, allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises and practical demonstrations.
Knowledge and understanding
Students should be able to demonstrate:
- Basic knowledge and understanding of the principles and history of GMP for microbiology labs.
- An understanding of the differences between QA and QC.
- An understanding of the role of the microbiologist in QA and QC
- An understanding of how to manage GMP issues in the Microbiology field.
Students will be able to demonstrate:
- Application of the principles to real life situations that occur in the Microbiology Laboratory.
- Application of the principles of validation in microbiology processes.
- Application of microbiology skills in GMP training plans.
Students will be able to:
- Apply their learning and knowledge back in the workplace.
- Demonstrate key QA and QC skills in the microbiology laboratory.
Transferable skills and personal qualities
Students will be able to:
• Use QA and QC principles in other GMP environments outside the microbiology laboratory.
• Apply validation skills outside the microbiology field of interest.
|Written assignment (inc essay)||100%|
How and when feedback is provided
Weighting within unit (if relevant)
Feedback returned by email within 15 working days
Feedback returned by email within 15 working days.
• “Rules and Guidance for Pharmaceutical Manufacturers 1993”, MCA, HMSO, 1997.
• PDA Technical Report No. 33, Evaluation, Validation, and Implementation of New Microbiological Testing Methods (2000) PDA J Pharm Sci Technol, Suppl. TR33, Vol.54(3).
• PDA Technical Report No. 13, (2001) Fundamentals of an Environmental Monitoring Progam (Revised)
• Pharmaceutical Microbiology – Essentials for Quality Assurance and Quality Control. T Sandle. ISBN 978-0-08-100022-9
|Independent study hours|
|Karen Capper||Unit coordinator|