This course provides an introduction to the types, sources, risks and control measures of contamination in relation the manufacturing of pharmaceutical products.
Objectives
- Recognise why contamination controls are critical to product quality
- Identify different types of contaminants
- Identify potential sources of contamination
- Identify the key types of contamination controls within a manufacturing facility
Topics and Content
- Introduction
- Objectives
- Reviews and assessment
- Contamination and quality
- What do you think?
- What do the GMP rules state?
- Overview
- Responsibility to patients
- Impure products are dangerous
- What about Quality Control (QC)?
- Select all the statements that are true
- Contamination sources
- What do you think?
- What do the GMP rules state?
- Where does contamination come from?
- More about microbes
- Personnel
- Manufacturing environment
- Factory air
- Equipment
- Water
- Cross contamination
- Examples
- How does contamination get into products?
- Contamination control
- What do you think?
- What do the GMP rules state?
- Written programs
- Buildings and premises
- Air control
- Cleanrooms
- Personal hygiene and gowning
- Environmental monitoring
- Housekeeping
- Facility cleaning
- Equipment cleaning
- Common versus dedicated equipment
- Cleaning equipment/utensils
- Starting materials
- Storage of materials
- Pharmaceutical water
- Controlling cross-contamination
- Room clearance
- Line clearance
- Example keg
- Which of the following are controls to address building and premise contamination?
- How should equipment be stored?
- Select True or False for each statement
- Conclusion
- Summary
Participants
This course is designed for induction of personnel new to GMP or as a refresher for experienced GMP personnel in any manufacturing-related roles including but not limited to facility/equipment/process engineering & design and manufacturing/packing/warehouse 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.
