During this training, you will be presented with the following elements:
- What is GLP, to what does it apply and why?
- You will receive an overview of the existing legislation
- The GLP guidelines will be explained using practical examples
After this training, you will be familiar with the importance of the guidelines and have insight regarding compliance with these within your company.
Why this topic?
Safety for health and the environment of (animal) drugs, cosmetics, food additives, industrial chemicals and pesticides must be studied. Laboratories/authorities that carry out this research are required by law to abide by specific guidelines: the GLP (Good Laboratory Practice) guidelines.
Not all laboratories are required to work according to GLP, only those that carry out the abovementioned research.
GLP tries to provide organisations with a quality assurance system to ensure, among other things, that the data generated in the laboratory are reliable and traceable. This requires a specific modus operandi that makes knowledge of GLP necessary for each employee. The rules must be followed.
They are discussed in this training but it is also explained why they are set up in this way.
What can you expect during the training?
- You will be given an overview of the GLP legislation and expectations of authorities. Not only from a purely theoretical perspective, but also practical application.
- You will acquire a sound basic knowledge of working in a GLP environment.
- Where the focus lies during an inspection will be explained.
What is the result in your daily work?
Knowledge of and acting in accordance with GLP guidelines is a requirement for all employees of laboratories/authorities that have to comply with GLP legislation.
- Participants know who the various legislative authorities are and what their role is in relation to GLP
- Participants have a good insight into GLP
- Participants understand when and why they should apply the GLP rules
You work in a regulatory environment, or will shortly be working in a quality laboratory that has to deal with GLP.
Note: the instructors have no experience of animal testing and this aspect of GLP is not dealt with in the course.
- Why GLP?
- Who/which laboratories (activities) has/have to comply with GLP
- Various authorities
- Overview of legislation
- Supervisory authorities
- Organisation/staff: training, hygiene
- Programme for quality control
- Facilities in a laboratory environment
- Equipment (possibly software-controlled) and material: calibration, qualification/validation
- Test and reference material
- Analytical methods and validations (Pharmacopoeia): materials and reagents, specifications and out of specifications (OOS), change of control
- Work instructions – SOP
- Carrying out the research
- Reporting and storage of data
- Loss of qualification