Records Management for Good Laboratory Practice (GLP)

October 13, 2020

In the pursuit of scientific and medical advancement, pharmaceutical companies and medical instrumentation makers are in a constant state of research and discovery. While this research is absolutely critical to the betterment of medicine and the improvement of society as a whole, the way in which the research is conducted and documented needs to be strictly defined and carefully monitored to protect the public against errors and bad actors. 

In the early days of pharmaceutical research, there were almost no restrictions on the methods used, with different researchers and laboratories each adhering to their own standards. However, after several unfortunate incidents which resulted in unsafe products making it to market or test subjects being harmed, governments around the world began to develop official best practices guidelines and regulations to enforce them. One such set of guidelines is Good Laboratory Practice (GLP).

What is Good Laboratory Practice? 

Good laboratory practice is one of a host of good practices guidelines known collectively as GxP. Initially implemented by Denmark and New Zealand in 1972, a version of good laboratory practice was brought into law in the USA by the FDA in 1978. However, the increasingly global pharmaceutical industry quickly made for complications when navigating the different versions of GLP that were implemented by each country. So, in 1992 the Organization for Economic Co-Operation and Development (OECD) introduced its own universal GLP guidelines which were adopted by all member states. The FDA maintains its own good laboratory practice regulation, known as 21 CFR 58, but the principles and guidelines mirror those of the OECD. 

GxP guidelines and regulations cover every aspect of the research, production, manufacturing, and distribution of drugs and medical instruments. GLP refers specifically to non-clinical laboratory or field studies that are conducted in support of the research and discovery of regulated substances and instrumentation. The non-clinical nature of the studies means that they exclusively involve non-human participants. It is important to note that, as with all GxP principles, good laboratory practice principles are intended as a quality management system. This means that it is concerned with the conduct of those involved in the study and the documentation of their actions for auditing purposes, rather than the scientific quality of the research. 

According to the FDA 21 CFR 58.1, GLP should be adhered to in any non-clinical studies that support the safety of: 

  • Human drugs and biological products

  • Medical devices for human use

  • Electronic products

  • Food and color additives

  • Animal food additives

  • Animal drugs

Good Laboratory Practice Examples 

There is a wide variety of non-clinical laboratory and field studies that fall under GLP regulations. Good laboratory practices should be adhered to when conducting any of the following types of study:

  • Physical-chemical testing

  • Toxicity profiles

  • Mutagenicity studies

  • Environmental toxicity studies 

  • Safe levels of use studies

  • Bioaccumulation studies in food or animal feedstuffs

  • Analytical and clinical chemistry testing

Good Laboratory Practice Principles

The principles of good laboratory practice are all aimed at improving the quality, consistency, and auditability of pre-clinical or non-clinical trials. With GLP in place, it allows for lower barriers to trade, safer clinical trials, and the avoidance of duplication of research. GLP principles are very detailed and many will only pertain to specific types of study. However, there are six principles which make up the foundation of GLP:

Quality Assurance

The first step in GLP compliance is implementing a Quality Assurance (QA) program. The goal of a QA program is itself to ensure that the other principles of GLP are implemented properly and adhered to. This should be properly documented, with the person(s) responsible for the QA program clearly identified. 

Equipment, Reagents, and Materials

GLP has lengthy guidelines for the handling, calibration, and storage of all equipment, reagents, and materials used in the laboratory. At the core of compliance, however, is that all procedures that govern how apparatus and materials are handled, tested, and maintained be properly documented and made available to all study personnel. 

Facilities

The facilities used for testing must meet certain standards to be in compliance with GLP. These include having adequate separate spaces to protect against contamination, suitable storage spaces to ensure the quality of materials, and proper waste disposal facilities, among others. GLP also dictates the conditions that must be met for animal care facilities.

Personnel Responsibilities

Ensuring that personnel is properly trained and informed plays a significant role in GLP compliance. Records of training and personnel responsibilities should all be clearly documented. The actions of individual personnel should also be accurately documented to provide an audit trail in the case of an audit. 

Standard Operating Procedures (SOPs)

As important as having a quality assurance program is having standard operating procedures in place. SOPs should clearly define all of the procedures involved in maintaining GLP compliance and be readily available to all personnel. 

Records Management 

The steps taken to ensure that GLP has been followed are all meaningless if it cannot be proved. The FDA has clear guidelines on how long records documenting GLP compliance must be maintained. A GLP study should ensure it has adequate archival space and a robust records management system in place. 

Good Laboratory Practice Record-Keeping

As noted above, good laboratory practice record-keeping is an essential component of compliance. Every aspect of GLP is affected by records management, from the documentation of responsibilities to the accurate recording of study results. Without a comprehensive records management system in place, compliance will be impossible to prove in the event of an audit. 

The most crucial component of good laboratory practice record-keeping is maintaining and proving data integrity. The OECD uses the acronym ALCOA to define the criteria that a records management system meet to be GLP compliant:

Attributable - Who performed an action and why?

Legible - Data must be recorded securely and must be legible

Contemporaneous - Data should be recorded at the time that the action occurs

Original - Information should be held in original documents or certified copies 

Accurate - No edits should be performed outside of documented amendments

Good Laboratory Practice Training

Any member of personnel that is involved in the quality assurance of non-clinical or preclinical studies should absolutely be trained fully on GLP guidelines and principles. There is no single accredited body that provides GLP training. Most degrees in pharmaceutical or medical fields with a research component will provide GLP training as part of their syllabus. 

For those that did not receive GLP training as part of their degree, or who need to ensure that their knowledge is current, there are a number of organizations around the world that offer GLP certification training programs that will certify attendees as a Good Laboratory Practice Certified Professional (GLPCP). While programs differ in scope and depth to some extent, any GLP certification course should cover the following: 

  • The scope of research that GLP covers

  • Definitions of terminology

  • How to inspect a testing facility

  • Personnel roles and responsibilities

  • Testing facility management

  • Implementing a quality assurance program

  • Managing animal care facilities

When exploring GLP certification training programs, be sure to review the syllabus to see if it covers all of these aspects of GLP compliance and implementation.  

Summary

Good laboratory practices play an essential role in ensuring the quality of the research to distribution pipeline for pharmaceuticals and medical instruments. All non-clinical and pre-clinical studies that will support an application to the FDA for the marketing of a substance or product should ensure that they meet GLP requirements. 

As with all GxP guidelines, meeting GLP compliance can be complex. Not only must principles be implemented and followed, but they must also be fully and correctly documented to prove compliance. However, with the proper training, documentation of SOPs, and a compliant-ready records management platform in place, compliance can be relatively straight forward.

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