GLP concepts in Flow Cytometry

What is Good Laboratory Practice (GLP)?

No doubt you have come across the term GLP (Good Laboratory Practice) when considering conducting a nonclinical study. But when should a study be performed under GLP conditions?

The principles of GLP

Let’s first briefly define what the Principles of GLPs are in order to understand when to use them. GLP is a quality system that allows the conduct of a non-clinical study to be performed under a set of standards that ensure the quality, reliability, and integrity of the study, including reporting and traceability of the data. To achieve this, GLP requires defined roles and responsibilities within each study, which are determined to be just as important as the execution itself 1.

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These include:

Test Facility Management - whose role is to ensure that sufficient qualified personnel, equipment and materials are dedicated to each program. As part of this, TFM is responsible for ensuring up to date record keeping of personnel training and experience that appropriately reflects their job description and responsibilities within the organization. The TFM assigns several of the GLP compliance responsibilities including the archiving of study documentation and data, IT security and compliance practices, workplace safety (training, ergonomic and PPE equipment) and facilities management (see below). Most importantly, the TFM assigns a Study Director and is intrinsic to the functioning of the Quality Assurance Unit’s activities within the organization.

Study Director - whose roles include the approval of protocols and study plans relating to any GLP-program and communicate these effectively with the lab personnel and Quality Assurance Unit. It is also the SD’s responsibility to analyze data and provide a report that accurately reflects the data in the study, before signing off on the report to acknowledge acceptance of the study outcome once completed.

Quality Assurance Unit - work to ensure that the study is completed in compliance with the principals of GLP. This includes ensuring equipment, personnel, methods, practices, records and controls all confirm with the regulations. The deviation process, in-phase studies, and final reporting statements are also overseen by this group.

Facilities role includes ensuring the workspace is suitable for the work being conducted. This includes air handling and environmental monitoring.

As previously mentioned, other GLP requirements include the archiving of all documentation and data for safekeeping and the safe disposal of all waste products.

When do we apply GLP?

Any new biomedical product needs to be evaluated for its safety and mode of action in the laboratory setting before it can be safely tested in human populations in clinical trials. These studies are termed “nonclinical” and can be defined as a study that supports a clinical trial or a regulatory submission to the FDA, which could include animal safety testing and efficacy studies, toxicology, and pharmacokinetic studies, or an investigational new drug application. Once reaching the clinical trial stage, studies would then be performed under GCP (Good Clinical Practice) or GCLP (Good Clinical Laboratory Practice) guidance 2.

Consider the following:

Are you trying to determine: efficacy of your product? If your medical device materials are appropriate? The purity of your product? Characteristics of a drug or biologic? If so, then the study can be conducted as non-GLP.

Is your product ready for safety testing? Are your studies intended to support applications for research or marketing permits? If so, your study should be performed in compliance with FDA GLP regulations 3,4.

GLP-compliant protocols

Each GLP study must have an approved written protocol prior to the study start that clearly indicates the objectives and all methods for the conduct of the study. A GLP-compliant protocol must be developed to satisfy specific criteria stated in the FDA regulations, and this process can be more costly and time-consuming than developing a protocol for non-GLP studies. Consider consulting with an expert in GLP compliance to assess your GLP needs. Proper planning can make the adaptation of GLP protocols more manageable and less overwhelming.

Benefits of GLP

GLP is an FDA regulation that is accepted and approved as an international standard by the Organization for Economic Cooperation and Development (OECD). As such, GLP reflects a high standard of quality to ensure the integrity of the study, with the goal of increasing public confidence in the research and development process and shortening time-to-market for new products.

For companies such as FlowMetric who work under the principals of GLP, our focus is to establish a positive reputation with our clients and maintain our image as a quality producer in the Global Marketplace.

GLP Comparison chart: https://www.fda.gov/media/75819/download

Authored by: Erin Range

Erin joined the FlowMetric team as a Senior Quality Associate with over 15 years of quality assurance experience in toxicology and bioanalytical studies for the contract research industry. In addition to being a senior QA auditor for GLP (Good Laboratory Practice) studies she has been a successful project leader on various quality improvement projects. She is a member of the Society of Quality Assurance (SQA) and Mid-Atlantic Region Society of Quality Assurance (MARSQA) and has served as a Director on the board for MARSQA.

Erin graduated from Delaware Valley College in Doylestown PA with a BS in Animal Science.