This course addresses the importance of implementing and complying with cleaning and sanitising procedures and why the responsibilities apply to all GMP staff (not just cleaners).
Objectives
- Define “cleaning” and “sanitation”
- Recognise why you need to clean before you sanitise
- Identify GMP requirements for documenting cleaning and sanitising activities
- Explain the reasons why you must use only approved cleaning and sanitising materials
- Explain why cleaning and sanitation prevents product contamination
Topics and Content
- Introduction
- Objectives
- Reviews and assessment
- Defining cleaning and sanitation
- What do you think?
- What do the GMP rules state?
- Types of contamination
- What is cleaning?
- What is sanitation?
- What is sterilisation?
- Sanitising agents
- Cleaning procedures and records
- What must be cleaned?
- How clean is "clean"?
- Protecting yourself
- Why do we need to clean?
- Fill in the blanks
- True or false?
- Facility cleaning
- What do you think?
- What do the GMP rules state?
- Overview
- More about air controls
- GMP cleaning issues
- Buildings and grounds
- Inwards goods and storage areas
- Cleaning the facility
- Cleaning techniques
- Pest control
- True or false
- Equipment cleaning
- What do you think?
- What do the GMP rules state?
- Overview
- Equipment cleaning challenges
- Common and dedicated equipment
- Cleaning validation
- Hold times and agent contact time
- Cleaning status tags
- Water
- Cleaning agents
- Cleaning equipment/utensils
- Clean-In-Place (CIP)
- CIP considerations
- What proves that cleaning processes consistently remove the previous product?
- True or false?
- Which type of equipment presents the greatest risk of product cross-contamination?
- Cleaning records
- What do you think?
- What do the GMP rules state?
- Overview
- Status tags and cleaning logs
- Select all that apply
- Conclusion
- Summary
Participants
This course is designed for induction of personnel new to GMP or as a refresher for experienced GMP personnel because cleaning is a key responsibility of all GMP operations.
Assessment / Certificate
There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.
A PDF Certificate is issued upon passing the quiz.
Duration
The course is expected to take approximately 1 hour.
Access
For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.
For individuals, you can buy now for $149 (ex GST) and your licence grants you access to the course for 30 days.
Contact us with any questions.
