QP pharmaceutical microbiology

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3 Day/s

CPD Hours: 21

Classroom, online

RSC approved

The Qualified Person needs to understand the significance of the presence of bacteria, yeasts moulds, viruses and toxins in pharmaceutical raw materials, intermediates, products and pharmaceutical production environments. In addition, the QP needs a good understanding of the microbiological control of pharmaceutical products, production environments and people.

This course will cover the main types and sources of micro-organisms and the issues associated with them in relation to both sterile and non-sterile pharmaceutical production. Specific sessions will cover water systems, clean room design and operation, the concept of sterilisation and sterility assurance.


The classroom version of this course, includes a microbiology practical session on the third day, run at RSSL's microbiology and sterility laboratory in Wokingham.


RSC Logo Approved Training High Res (1)
This course is one of a series of modules designed specifically to satisfy the requirements of the QP study guide. It is a popular module for trainee QPs who are non microbiologists. It will also be of benefit to other Quality Professionals, Production Technologists and support functions. In addition, this module produces an ideal opportunity for those who need to ensure they carry out Continuing Professional Development.
The course includes the following topics and reinforced using group exercises:


  • Day 1
    • Microbiology and QP Study Guide
    • Microbiology and Microorganisms
    • Ecology & Significance of Microbes
    • Contamination Control
    • Manufacture of Sterile Products in Clean Rooms
    • Water Microbiology
    • Sterilization Principles and Assurance
    • Sterilization Processes and Depyrogenation
  • Day 2
    • Disinfection and Sporicidal Agents
    • Testing - Environmental Monitoring
    • Cherwell Demonstration
    • EM Limit Setting
    • Media Fills
    • Control of Media, Reagents & Equipment
    • MLT, Specified Organisms and Water Testing
    • Sterility Testing
    • Rapid Enumeration methods of Testing
    • Microorganism Identification
  • Day 3
    • Endotoxins and Pyrogens
    • Laboratory session (classroom course only), includes Laboratory safety, MLTs, Gram staining Finger dabs and swabs
    • Water Activity Testing
    • Antimicrobial Efficacy Testing
    • Biological Assays
    • Failure Investigation and OOS

    At the end of the course you will:


    • Understand the sources and types of microorganisms relevant to pharmaceutical production operations
    • Understand the microbiological controls required for both sterile and non-sterile products
    • Appreciate the microbiology of water, its production and distribution systems
    • Appreciate test methods often used and the interpretation of microbiological data
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Meet the tutors

Andy Martin

A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.

Aaron Asare

Aaron is Cultures Laboratory Supervisor in RSSL's Global R&D Biological Sciences department.

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