MSc Pharma Micro Modules

Modules

Currently there are 9 modules available in the PMAT programme and these are outlined below:

PMAT Module 1: Introduction to Pharmaceutical Microbiology and Technology

  • Unit 1: Overview of the Pharmaceutical Industry
  • Unit 2: Pharmaceutical Dosage Forms
  • Unit 3: Risk Assessment
  • Unit 4: Water and Raw Materials
  • Unit 5: Environmental Control
  • Unit 6: Preservation and Sterilisation
  • Unit 7: Basic Laboratory Techniques
  • Unit 8: Manufacturing Procedures and Validation
  • Unit 9: GMP and Documentation
  • Unit 10: Regulatory Affairs

Module 1 will be compulsory to all students that wish to register for the PMAT programme as a Certificate, Diploma or MSc.
This is not the case if you simply wish to register for individual modules.


PMAT Module 2: Water Aspects

  • Unit 1: Water Qualities Defined
  • Unit 2: System Design & Water Generation
  • Unit 3: Validation & Change Control
  • Unit 4: System Operation & Sanitisation
  • Unit 5: Sampling and Microbiological Testing
  • Unit 6: System Troubleshooting
  • Unit 7: Water System Management


PMAT Module 3: Microbiological Environmental Monitoring & Control
(Sterile and Non-sterile Areas)

  • Unit 1: Introduction to Environmental Monitoring and Consideration of Regulatory Issues
  • Unit 2: Viable and Non-viable Monitoring Methods
  • Unit 3: Validation of Environmental Monitoring Methods
  • Unit 4: Designing an Environmental Monitoring Programme
  • Unit 5: Monitoring of Specific Processes
  • Unit 6: Data Handling and Trend Analysis
  • Unit 7: Micro-organisms
  • Unit 8: Risk Assessment
  • Unit 9: Classification of Clean Rooms and Clean Zones


PMAT Module 4: Microbiological Aspects of Sterile Pharmaceutical Manufacturing

  • Unit 1: Sterile Products, Sterility and Sterility Assurance
  • Unit 2: Pharmaceutical Preparations Required to be Sterile
  • Unit 3: Maintenance of Sterility – Containment of Sterile Pharmaceutical Preparations
  • Unit 4: Terminal Sterilization and Aseptic Manufacture
  • Unit 5: The Test for Sterility
  • Unit 6: Sterility Assurance as Applied to Sterilisation Processes
  • Unit 7: The Sterility Assurance Concept versus Aseptic Manufacture


PMAT Module 5: QA in Microbiological Laboratories

  • Unit 1: Introduction to Module
  • Unit 2: System Design and Water Generation
  • Unit 3: QC, QA and Good Manufacturing Practice
  • Unit 4: QA, GMP, QC, Regulations and the Law
  • Unit 5: Personnel and Training
  • Unit 6: Documentation
  • Unit 7: Further Aspects of GMP
  • Unit 8: Validation
  • Unit 9: Quality Control, Good Quality Control Laboratory Practice and Calibration
  • Unit 10: Sampling, Statistical Process Control, "Parametric Release" and Quality Auditing
  • Unit 11: Wider Aspects of GMP/QA and "TQM"
  • Unit 12: References

PMAT Module 6: Engineering Principles for Microbiologists

  • Unit 1: Engineering Terminology
  • Unit 2: Engineering and the Regulations, Guidance & Standards
  • Unit 3: Principles of Project Management & Design
  • Unit 4: Critical Utilities
  • Unit 5: Hygienic Design (references)
  • Unit 6: Environmental Control & HVAC
  • Unit 7: Commissioning & Qualification of Engineering Systems

PMAT Module 7: Application of Microbiology in Biopharmaceuticals

  • Unit 1: Introduction
  • Unit 2: Legislation and Guidelines in Biopharmaceuticals
  • Unit 3: Biopharmaceutical Technology
  • Unit 4: Mammalian Cell Culture
  • Unit 5: Analysis of Biopharmaceuticals
  • Unit 6: Microbiological Challenges
  • Unit 7: Application of Disposables to Bioprocessing
  • Unit 8: Module Summary and Future Prospects

PMAT Module 9: Microbiological Potency testing of Growth-inhibiting and Growth-promoting Substances

  • Unit 1: Overview
  • Unit 2: The Essential Tools of Microbiological Assay (1): Test Organisms
  • Unit 3: The Essential Tools of Microbiological Assay (2): Reference Standards
  • Unit 4: Good Laboratory Practice
  • Unit 5: The Agar Diffusion Assay: It's Quantitative Bias
  • Unit 6: The Theory and Practice of Tube Assays for Growth-inhibiting Substances
  • Unit 7: The Theory and Practice of Tube Assays for Growth-promoting Substances
  • Unit 8: Preliminary Evaluation of Data
  • Unit 9: The Design and Evaluation of Parallel-line Assays
  • Unit 10: Slope Ratio Assays, some Designs and their Evaluation
  • Unit 11: Choice of Experimental Design and Factors Influencing Accuracy and Precision
  • Unit 12: Miscellaneous

PMAT Module 10: Key Management Tools

  • Unit 1: Understanding Yourself
  • Unit 2: Influencing a Matrix Organisation
  • Unit 3: Leadership Styles and Choices
  • Unit 4: Managing Difficult Relationships
  • Unit 5: Change Management
  • Unit 6: Motivating Others and Yourself
  • Unit 7: Presenting Information
  • Unit 8: Managing Performance
  • Unit 9: Finance Skills
  • Unit 10: Managing Resources

The heading of the remaining PMAT Module, which is due for completion in 2010 is:

  • Module 8: Antimicrobials

To download the PMAT Course Modules Synopsis please click on the following link:

http://pharmig.org.uk/pmat/download/PMAT.pdf