GLP Training: GLP Control in Non-Clinical Environments

By: Marci Lynn Crane

GLPs (Good Laboratory Practices) are meant to aid non-clinical laboratories in achieving consistent and effective product results over time.

Like any quality-related regulatory practices, the GLPs, when managed poorly, are liable to cause dilatory pauses in production, which any good business professional---or researcher for that matter---is likely to resent. When all is said and done, it's the age-old teeter-totter balance of quality vs. speed.

Find the Healthy Balance
When aspects of GLP control are considered closely however, it's surprisingly apparent that a healthy balance between quality and speed can become a viable reality for laboratories everywhere.

This article focuses on one aspect of GLP control: GLP training.

GLP Training: Important or not so important?
GLP training is the process of educating employees in regards to understanding and adhering to GLP regulations. Thankfully however, most laboratory professionals (with good reason) choose not to train their employees with rote readings of the FDA's 21 CFR Part 58 regulation (the regulation that outlines GLP). Instead, a laboratory trainer is likely to explain the connections that exist between the laboratory's unique goals and procedures and the GLP regulations themselves. Since every laboratory will create unique connections and GLP-molded procedures, each GLP Training session will vary. However, there are a few common GLP training factors that can make or break not only GLP training but GLP control for any non-clinical laboratory.

These factors are listed as follows:

1) GLP Training Requires the Comprehension of Employees
A major question that must be answered when considering the effectiveness of a GLP training session is whether or not employees understand the relationship of company procedures and GLP regulations. A training examination, for instance, can be graded to determine a level of understanding but sometimes one training session isn't enough. Similar training sessions may need to occur 3-6 months after the initial session and subsequently at annual intervals.

2) Superior GLP Training Requires Document Control
GLP training requires document control. From SOPs to product design files and from design files to quality manuals, the foundation for successful quality is (or should be) written on a laboratory's quality control documents. Unfortunately, many non-clinical environments often http://www.mastercontrol.com/solutions/document_control_fb.html"">control documentation with paper-based or hybrid processes. When controlled with these processes, documentation can easily become lost, and "extinct" versions of a quality SOP can be distributed unknowingly to lab employees conducting research. Even if those employees have been properly trained, if the SOPs don't match the latest training, many employees will trust the documents they have access to. Document control software is highly recommended for non-clinical laboratories. Not only can document versions be tracked and controlled (even on the floor) they can also make training examinations and other documents easy to distribute, collect, archive, and search for leaving a laboratory with more valuable hours for the project that count. Also, look for a solution that combines scheduling, tracking, easy-search and reporting (analytics) features.

Save the Quality Department!
It isn't uncommon for those in charge of quality to be overwhelmed when it comes to managing quality control across departments. Let's say for instance that a CAPA (Corrective and Preventative Action) form has been completed in relation to a faulty device. Out of the devices produced, 9% have proven to be faulty. The quality team eventually tracks these errors to two particular employees, who due to incomplete training, have been twisting one of the device components on backwards. Wouldn't it be great if the CAPA form (instead of being a paper that had to be transferred from office to office) was an electronic form, and wouldn't it be great if that form automatically triggered electronic training preparation tasks? Better yet, wouldn't it be even better if initial training sessions were monitored and the poor training had been identified weeks or even months earlier?

This GLP training wish list is certainly by no means an impossible endeavor. There are electronic solutions that streamline documents and connect CAPA and training processes, leaving laboratories the time they need to think about investigative science and quality control employees with less of a need for guesswork and tedious manual tasks.

Conclusion
GLP Training is indeed an essential part of the non-clinical environment but like most reoccurring processes, GLP Training is best when controlled by current technologies.

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