GLP Lab vs. Non-GLP Lab: What’s the Difference?

Laboratory compliance standards are critical in pharmaceutical development and regulatory approvals. GLP labs are the foundation for achieving these laboratory compliance standards. GLP labs are not just focused on supporting and conducting non-clinical studies intended for drug products. They also support research and development of animal drugs, color and food additives, medical devices, and biological products.

Good laboratory practices (GLP) are quality control elements encompassing conditions and processes under which non-clinical studies are planned, conducted, monitored, reported, and recorded. Hence, the primary difference between a GLP and a non-GLP lab is to conduct non-clinical studies with good laboratory practices. Most importantly, GLP Labs focuses on conducting non-clinical studies. GLP principles are not considered for human studies. This article discusses the difference between GLP and non-GLP labs.

Understanding the standards of GLP bioanalysis

GLP Bioanalysis Labs operate under regulatory systems developed to ensure study reliability and data integrity for regulatory compliance. Let us consider the regulatory compliances and standards of GLP bioanalysis:

Personnel

• All GLP laboratory personnel should have the training, education, and experience to perform all assigned functions.
• GLP labs should document the experience and training of individual laboratory personnel.
• GLP labs should have personnel and staff for the timely conduct of non-clinical studies.
• Staff should take necessary health precautions and wear appropriate clothing for non-clinical environments.

Testing facility management

• GLP labs should assign a study director before initiating a study. Besides, if necessary, they should promptly replace a study director during the investigation.
• Assure the presence of a quality assurance team.
• Appropriately test mixtures and control articles for purity, identity, strength, uniformity, and stability.
• Ensure the availability of resources, facilities, personnel, materials, and equipment as scheduled.
• Assure that laboratory staff understand their roles and functions, and any deviation from assigned protocols is reported promptly.

Study director

For each study, a scientist, researcher, or other personnel with necessary experience, education, and training should be appointed as a study director. The study director should focus on the technical aspects of the study and analysis, interpretation, reporting, and documentation of results. He/she should ensure that:

• The study protocol is approved
• All experimental data are appropriately stored and verified
• Unforeseen situations are adequately handled and noted, and corrective measures are initiated
• All good laboratory practices are followed
• All data, specimens, protocols, reports, and documentation are accurately stored in the archives

Must Read: Role of a Bioanalytical Lab in Pharmacokinetic and Toxicology Studies

Quality assurance unit

A GLP laboratory should have a quality assurance unit to monitor each study and ensure that the equipment, facility, methods, practices, personnel, control, and records are compliant with regulatory specifications. Importantly, this quality assurance unit should be an independent team from other laboratory staff and personnel. This assurance unit should:

• Maintain the master schedule sheet of studies performed at the laboratory
• Maintain study protocols
• Inspect studies at adequate intervals
• Submit periodic reports to the study director
• Maintain correct protocol or SOP following
• Review the final report to assess accuracy and compliance

Facilities

All GLP laboratories should be of appropriate construction and size for the proper conduct of research studies. Each lab should have a specific degree of space and separation to prevent unnecessary impact on activities or function, having adverse effects on study data. The different types of facilities in a GLP lab include:

• Animal care facility
• Animal supply facility
• Laboratory operation area
• Facility for handling control and test articles
• Facility for storing data and specimens

Equipment

All equipment used to generate, assess, or measure data and used to control laboratory parameters should be of adequate capacity and design to function at peak performance and accuracy. Besides, the location of this equipment should be ideal to facilitate regular cleaning, inspection, operation, and maintenance. 

Non-GLP lab characteristics

By definition, non-GLP labs are facilities that do not follow GLP guidelines. This approach does not mean they are not conducted with utmost accuracy and compliance. Non-GLP labs typically focus on exploratory studies and early-stage development.

The primary goal of non-clinical studies is accurate and compliant data. The data acquired in non-clinical testing forms the basis for subsequent human trials. Hence, accurate data is critical during non-clinical studies. This need for accuracy and compliance necessitates the employment of GLP specifications. On the other hand, non-GLP labs offer faster turnaround time, fewer documentation requirements, and greater protocol flexibility. The primary goal of non-GLP labs is to assess preliminary research, feasibility studies, and method development. These initiatives do not require the extensive quality assurance as needed for GLP laboratories. Hence, clients and drug developers can effectively reduce costs and increase operational efficiency without overly investing in regulatory protocols. In conclusion, non-GLP labs are critical in drug discovery and the preliminary developmental phase, where regulatory submissions are not necessary.

Which lab to choose?

The fundamental differences between a GLP and a non-GLP lab are regulatory compliance, intended applications, and operational requirements. A proper lab selection affects regulatory acceptance, data quality, and overall development success. Hence, the sponsors should ideally choose between a GLP and a non-GLP lab based on study objective, development phase, and regulatory requirements. Understanding these differences is critical to making informed decisions in biotechnology and pharmaceutical development.