Glp Training: a Tool is Better Than a Task

Every laboratory’s checklist should include appurtenant GLP training for its employees but do you have to invest in a 3rd party trainer or is it something you can do yourself?

GLP Training? Why is it necessary?
GLP (Good Laboratory Practice) standards are necessary because before the GLPs were created not every medicine sold via a laboratory was effective or safe. Outright deception--though not common--could happen without the safety net or bullet proof vest of quality standards and practices. In the “end,” enough deceptions were taken note of (and taken account of) so the lab deceptions issue went to Congress. Thus it was that in the 1970s and the 1980s the CLIA amendments and GLP standards were established.

The OECD Defines
The OECD (Organization of Economic Cooperation and Development) assists in the delineation of good laboratory practices. In a current online publication1, OECD principles--in relation to good laboratory practice—are said to delineate the following laboratory exigencies:

“...a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”

The list (i.e. planned, performed, monitored, recorded, archived and reported) is the important aspect of the delineations defined by OECD’s principles. These processes must occur in every laboratory. You might notice however that these terms are broad and as long as they are thoroughly met leave room for a broad range of scientific creativity and flexibility, which means that GLP training can be simple once the planning, performing, monitoring (etc.) have been properly documented. However, as you have probably already guessed the process isn’t always as simple as it sounds. In fact, the indefinite definitions and restrictions of the GLPs make them even more difficult to document and support. Notwithstanding, the GLPs can be more of a catalyst to modern science than a detriment. The problem is that many lab professionals view GLPs as tasks to be accomplished instead of the tool they were designed to be, when in fact the GLPs and the GLP training processes have already been transformed into a tool as tangible and workable as a hammer or a miter saw.

The GLPs and GLP Training Tool
You might have already guessed that the GLP/GLP training tool is a software solution and you are correct. One of the points that I wish to make however before describing the type of GLP/GLP training tool that you should look for is that perhaps surprisingly even the language used to describe additional ethereal GLP requirements sounds a lot like the lingo you could use to describe a software computer solution. Take a look at the following:

“The purpose of these Principles of Good Laboratory Practice is thus to promote the development of quality test data and to provide a managerial tool to ensure a sound approach to the management, including conduct, reporting and archiving, of laboratory studies.”

So, returning to the meat of the matter, if it really is possible that the GLPs and GLP training can be handled with managerial software tool is there a solution that exists that both standardizes the GLPs and GLP training while leaving room for extended regulations and internal manifestations of flexibility and creativity? The answer is that there might be several solutions that could help you turn your GLP tasks into a tool. All it takes is an understanding of your needs, research and comparison. To start, look for solutions that include the following features:

• Document Control (GLPs and GLP training processes are going to require a lot of documentation so your solution might as well include document control).
  
• Meets Compliance Regulations (this includes for the FDA, CLIA amendments, ISO, EMEA, SOX, etc.) Whatever type of regulations you have to meet, make sure your solution will conform to them.
  
• A Great GLP Training Module (a great GLP training module will allow you to train anyone, anywhere (online at least) about anything. Also, look for a training module that allows you to integrate with other software modules such as those designed for CAPA (corrective and preventive action), nonconformance, deviations, customer complaints, etc.