MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2022

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Course unit details:
Antimicrobials (PMAT 8)

Unit code PHAR71370
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 unit covers the following key areas:

Antibiotics: Major Classes and Modes of Action
Laboratory Evaluation of Antimicrobial Agents
Laboratory Evaluation of Disinfectants
Disinfectants: Process Validation and Current Regulatory Requirements
Preservation of Pharmaceutical Formulations
Preservative Efficacy Testing
Preservatives: Stability and Resistance
 

Aims

This unit aims to cover the three broad areas discussed above, namely:
 
(i) Antibiotics and Antimicrobial Chemotherapy;
(ii) Disinfection and Disinfection Validation;
(iii) Preservation of Sterile and Non-Sterile Pharmaceuticals. 
 
Examine the regulatory aspects relevant to each within the pharmaceutical industry.
 
Examine aspects of Current Good Manufacturing Practice (cGMP), process validation and efficacy testing as well as laboratory evaluation of antimicrobial agents are covered in the relevant units.

Teaching and learning methods

Students are provided with the learning material in soft copy form. The unit comprises 9 chapters covering the all the key areas of antimicrobials. Each unit 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 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:

•    Become familiar with the major antibiotic classes 
•    Understand the concept of selective toxicity with reference to the modes of action and targets of each class of antibiotic agent 
•    Gain an appreciation of the mechanisms by which bacteria elaborate resistance to antibiotics 
•    Appreciate the sources of antibiotics, namely, natural, semisynthetic and synthetic agents
•    Understand the standard methods for determination of antimicrobial activity of antimicrobial agents 
•    Gain an appreciation for the process of microbial biofilm formation and the features of the biofilm 
•    Become familiar with the terms minimum inhibitory concentration, minimum bactericidal concentration and minimum biofilm eradication concentration 
•    Understand the concept synergy and antagonism between antimicrobials in planktonic and biofilm assays 
•    Become familiar with current GMP guidance and regulations regarding antibiotic manufacture, specifically relating to dedicated facilities and antibiotics/APIs manufactured by processes involving cell culture and/or classical fermentation steps
•    Become familiar with the main classes of disinfectant, their modes of action and advantages and disadvantages associated with their use 
•    Understand the standard laboratory methods for evaluation of disinfectant agents and the design of such standard methods to permit evaluation of disinfectant attenuation 
•    Understand the factors influencing the selection of disinfectants for a given process 
•    Understand the concept of disinfection process validation  
•    Become familiar with disinfectant efficacy tests and the Comité European de Normalisation (CEN) ‘tiered test’ approach and application of CEN methods. 
•    Become familiar with the concept of disinfectant rotation and the issues surrounding it 
•    Become familiar with the current regulatory aspects which affect disinfectant and biocide manufacture, marketing and use, including cGMP, The Biocidal Products Directive and REACH 
•    Become familiar with the concept of preservation of pharmaceuticals and the characteristics of an ‘ideal’ preservative 
•    Gain an appreciation of the major classes of preservative agent and their in-use concentrations 
•    Consider the basic approaches to product preservation 
•    Understand the approaches to preservation of non-sterile pharmaceutical products and be familiar with current acceptance criteria for various classes of pharmaceutical product 
•    Understand the approaches to preservation of sterile pharmaceutical products 
•    Understand the various conditions under which preservative efficacy can be attenuated in a pharmaceutical/drug product 
•    Become familiar with pharmacopoeial standards for preservative efficacy 
•    Demonstrate an understanding of the pharmacopoeial test methods for PET, including the specific conditions of the test with respect to container types, challenge organisms, environmental conditions and so on.   
•    Appreciate the interpretation of data and alternative methods for PET  
•    Become familiar with the International Conference on Harmonisation guidelines for in-use stabi

Intellectual skills

Students should be able to:

•    Apply the knowledge of disinfectants efficacy studies to practical use in the pharmaceutical industry.
•    Apply the knowledge of anti-microbial effectiveness studies to the drug development and testing protocols.
•    Apply the knowledge of the mode of action of antibiotics to the application in the pharmaceutical development process.
 

Practical skills

Students should be able to:

•    Understand the circumstances under which disinfectant activity may be attenuated and use this information to guide rational selection of disinfectants 
•    Apply the knowledge of antibiotic mode of action as a guide drug development process.
•    Apply the knowledge of preservative efficacy testing to interpret results and give appropriate guidance to drug development and QC testing.
 

Transferable skills and personal qualities

Students should be able to:

•    Understand the circumstances under which disinfectant activity may be attenuated and use this information to guide rational selection of disinfectants 
•    Apply the knowledge of antibiotic mode of action as a guide drug development process.
•    Apply the knowledge of preservative efficacy testing to interpret results and give appropriate guidance to drug development and QC testing.
 

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

•    A Guide to Disinfectants and their use in the Pharmaceutical Industry (2006), Pharmig Disinfectant Action Group, Pharmaceutical Microbiology Interest Group, Hertfordshire, UK. 
•    Antibiotic and Chemotherapy: Anti-infective agents and their use in therapy, Eighth Edition (2003) Finch, R.J., Greenwood, D., Ragnar Norrby S., Whitley, R.J. (Eds), Churchill Livingstone (Elsevier Science Ltd.), London, UK. 
•    Biofilms, Infection, and Antimicrobial Therapy (2006) Pace, J.L., Rupp, M.E., Finch, R.G. (Eds), CRC Press/Taylor & Francis Group, LLC., Florida, USA. 
•    British National Formulary 59 (2010) BMJ Group and Pharmaceutical Press, London, UK. 
•    Goodman & Gilman’s The Pharmacological Basis of Therapeutics, Tenth International Edition (2001), Hardman, J.G., Limbird, L.E., Goodman Gilman, A. (Eds), McGraw-Hill Inc., Medical Publishing Division, New York, USA. 
•    Handbook of Pharmaceutical Excipients, Fourth Edition (2003) Rowe, R.S., Sheskey, P.J., Weller, P.J. (Eds), Pharmaceutical Press, London, UK. 
•    Disinfection, Sterilization, and Preservation, Fifth Edition (2001) Block, S.S. (Ed) Lippincott Williams & Wilkins, Philadelphia, USA. 
•    Hugo & Russell’s Pharmaceutical Microbiology, Seventh Edition (2004), Denyer, S.P., Hodges, N.A., Gorman, S.P. (Eds), Wiley-Blackwell/Blackwell Publishing Ltd., Oxford, 
•    UK. (8th Edition due for publication January 2011) 
•    Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 Edition (2007), Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceutical Press, London, UK. 
•    ** An extremely useful online resource for easy navigation of the EU GMP Guide, with links to pdf versions of all Annexes is available at the following link: http://ternquay.com/Orange_Guide/Orange_Guide_Annex.html 
•    Russell, Hugo & Ayliffe’s Principles and Practice of Disinfection, Preservation & Sterilization, Fourth Edition (2004), Fraise, A.P., Lambert, P.A., Maillard, J-Y. (Eds), Blackwell Publishing Ltd., Oxford, UK.
 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Karen Capper Unit coordinator

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