Contamination Prevention and Control in a GMP Environment
Description:
Contamination is a serious concern for the pharmaceutical industry. The presence of contaminants such as non-viable particles, micro-organisms and their endotoxins can reduce or even inactivate the therapeutic activity of the drugs and can adversely affect patients taking the contaminated drugs. In this course, we will learn about the basics of contamination and the control measures and strategies to prevent pharmaceutical contamination.
Curriculum for this course:
Introduction
Overview | 49 secs |
Learning objectives | 32 secs |
Who should take this course? | 1 min 13 secs |
Course modules | 1 min 01 secs |
Module 1: Introduction to Contamination Prevention
Overview | 2 mins 05 secs |
Why the concern over contamination | 1 min 34 secs |
Vaccines | 1 min 20 secs |
Parenteral Medicine | 1 min 15 secs |
Terms explained | 3 mins |
Review Activity | 5 mins |
Module 2: Types of Contamination
Overview | 1 min 35 secs |
The FDA | 2 mins 35 secs |
What is contamination? | 1 min 23 secs |
What is cross contamination? | 2 min 10 secs |
Types of contamination | 1 min 38 secs |
Microorganisms | 1 min 02 secs |
Size of microorganisms | 1 min 30 secs |
Growing Microbes | 56 secs |
Different types of microorganisms | 1 min 34 secs |
Growth of microorganisms | 45 secs |
Rate of growth of bacteria | 1 min 02 secs |
Module 3: Sources of Contamination
Overview | 2 mins 10 secs |
Where does contamination come from? | 1 min 20 secs |
Sources of contamination | 1 min 40 secs |
Personnel | 1 min 34 secs |
Sources of viable contamination | 1 min 50 secs |
Human hands | 33 secs |
Skin | 25 secs |
Proper hand washing | 2 mins 05 secs |
Building and facility | 1 min 50 secs |
Equipment | 1 min 20 secs |
Materials | 1 min 55 secs |
Manufacturing process | 2 min 20 secs |
HVAC systems | 1 min 25 secs |
Modes of cross contamination | 2 mins 20 secs |
Review Activity | 5 mins |
Module 4: Quality Risk Management
Overview | 2 mins 20 secs |
QRM defined | 1 min 20 secs |
QRM team for contamination prevention | 55 secs |
ICH Q9 Quality Risk Management – Part 1 | 1 min 40 secs |
ICH Q9 Quality Risk Management – Part 2 | 1 min 20 secs |
FDA focus on risk assessments | 2 mins 30 secs |
QRM European Commission Insight | 1 min 10 secs |
Quality risk management tool selection | 2 mins 28 secs |
FMEA – Contamination preventation | 1 min 20 secs |
FMEA example | 2 min 20 secs |
Module 5: Contamination Control Strategies
Overview | 1 min 17 secs |
Control strategies | 2 min 10 secs |
Personnel – Part 1 | 58 secs |
Personnel – Part 2 | 1 min 47 secs |
Monitoring methods – people | 1 min 20 secs |
Gowning | 1 min 50 secs |
Facility building design – Part 1 | 1 min 25 secs |
Facility building design – Part 2 | 1 min 48 secs |
Facility building design – Part 3 | 1 min 10 secs |
Aseptic facilities | 1 min 33 secs |
Airlocks | 58 secs |
Pressure differentials | 1 min 44 secs |
HEPA Filters | 45 secs |
Laminar air flow | 1 min 10 secs |
Heating ventilation and air conditioning (HVAC) system | 2 min 17 secs |
Manufacturing process | 1 min 17 secs |
Access to areas | 2 min 17 secs |
Cleaning and disinfection – Part 1 | 1 min 30 secs |
Cleaning and disinfection – Part 2 | 1 min 48 secs |
Chemical agents | 1 min 16 secs |
Different type of chemical agents | 2 min 48 secs |
How to use the chemical agent | 1 min 18 secs |
Utilities | 1 min 50 secs |
Water | 2 min 17 secs |
Sterilization | 1 min 09 secs |
Sterile equipment | 1 min 01 secs |
Equipment – Part 1 | 1 min 57 secs |
Equipment – Part 2 | 2 min 18 secs |
Materials | 47 secs |
Conclusion
Final Assessment
Certification
Talk to us
Find out how we can help you bring your life science training to the next level.