MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2021

Coronavirus information for applicants and offer-holders

We understand that prospective students and offer-holders may have concerns about the ongoing coronavirus outbreak. The University is following the advice from Universities UK, Public Health England and the Foreign and Commonwealth Office.

Read our latest coronavirus information

Course unit details:
Introduction to Pharmaceutical Microbiology and Technology (PMAT 1)

Unit code PHAR71300
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This introductory unit will provide an overview of the pharmaceutical Industry and regulatory affairs covering all aspects of QA, QC, GMP and GLP, and consider documentation and health and safety issues. The design of premises and equipment for the laboratory and facility including quality audits will be covered.

Commonly encountered micro-organisms and basic laboratory techniques, including rapid methods will be discussed along with validation of processes and methods.

Aims

The unit aims to:

Provide the student with an introduction to pharmaceutical microbiology and introduce the PMAT programme. The unit is recommended for those taking any other part of the microbiology programme. The unit introduces the scope of pharmaceutical microbiology; how microbiology interfaces with drug development and GMP; risk assessment; contamination control; cleanrooms; environmental monitoring; pharmacopeia test methods; intermediate and finished product testing; assessment of raw materials; pharmaceutical water systems; disinfection and preservation; and validation.

Teaching and learning methods

Students are provided with the learning material in soft copy form. The learning material comprises 10 chapters covering all the key concepts of pharmaceutical microbiology and related technology. Each chapter contains a number of exercises together with suggested answers for students to check their learning as they progress through the unit. A reference list of further reading is provided for each chapter 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.

 

Knowledge and understanding

Students will be able to:

• Gain/refresh basic concepts of microbiology
• Understand the principles of pharmaceutical microbiology and its essential role in modern pharmaceutical manufacturing (both sterile and non-sterile products)
• Understand the beneficial use of microorganisms (e.g. biotechnology) in relation to pharmaceuticals
• Understand the risk (contamination) in relation to pharmaceuticals

Intellectual skills

Students will be able to:

• Understand the theoretical concepts in relation to microbial spoilage and survival
• Understand risks and applications of microbiology

Practical skills

Students will be able to:

• Understand key microbiological tests, which can feed into protocol, report and procedure writing
• Evaluate microbiological data and test results.

Transferable skills and personal qualities

Students will be able to:

• Apply information to different situations within the pharmaceutical sector (such as developing an understanding of microbiological growth towards both contamination control and the application of microorganisms to develop medicines).
• Assess how pharmaceutical products are manufactured from the microbiological perspective and be able to input into new drug development.
• Prioritise and effectively manage time to complete work by required deadlines
• Acquire technical skills in relation to understanding the array of microbiological tests required for quality control microbiology. 
• Formulate an argument, through completing the course assignment.

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

• Sandle, Tim (2015) Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control, Woodhead Publishing, Cambridge, UK
• Heritage, J., Evans, E.G.V. and Killington, R.A. (1996): Introduction to Microbiology, Cambridge: Cambridge University Press
• Black, J.G. (1996). Microbiology. Principles and Applications. Third Edition. Prentice Hall. Upper Saddle River, New Jersey. pp. 136-140
• Tortora, G.J., Funke, B.R., Case, C.L. (1995). Microbiology. An Introduction. Fifth Edition. The Benjamin/Cummings Publishing, Co., Inc., Redwood City, CA, pp. 155-158.
• Sandle, T. (2016) Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies, PDA / DHI, Bethesda, MD, USA
• Sandle, T. (Ed.) (2017) Industrial Pharmaceutical Microbiology: Standards & Controls, Euromed Communications, UK

 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Tim Sandle Unit coordinator

Return to course details