QP pharmaceutical microbiology

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.

SPECIAL OFFER - If you book our Introduction to Pharmaceutical Microbiology course, you will receive a discount of £350 off this course (excludes Trainee QPs on packages).

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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Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Andy Martin

Andy has over 35 years of pharmaceutical industry experience, beginning at Smith and Nephew in 1985 as a microbiologist, progressing to QA Microbiology Manager in 1996. During that time, he gained experience in QA and QC activities of the manufacture of sterile eye drops (terminally sterilized and aseptically filled), aseptically filled sterile creams and non-sterile syrups. In 2003 he became the RSSL Pharmaceutical Training Manager with responsibility for providing commercial pharmaceutical training courses. In 2007, Andy moved to Catalent pharma Solutions, in Swindon, as Microbiology Manager leading a team responsible for microbiological control of freeze-dried tablets and soft gel capsules. Andy gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events. In 2012 Andy set up ABM Consulting Ltd which offers services specializing in Microbiology, QA and Good Manufacturing Practice. Andy is also treasurer for the UKs foremost microbiology organisation, Pharmig.

Aaron Asare

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

Related course

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Introduction to pharmaceutical microbiology

If you attend this course, you will receive a discount of £350 (15%) off our QP Pharmaceutical Microbiology training course.