A laboratory is an exciting place. Among the many microscopes, test tubes, and Petri dishes, scientists continuously bring our species one step further in our evolution. However, scientific progress is only possible if research takes place in a safe, accurate, and well-regulated environment–which is where good laboratory practices (GLP) come in.
Behind modern scientific discoveries are a foundation of protocols, systems, and standards designed to uphold data integrity and protect public safety. GLP provides the framework laboratories need to generate reliable, reproducible results.
Whether you’re new to GLP or looking to refine your lab’s processes, this guide will walk you through the key components and best practices for GLP compliance.
What are good laboratory practices?
Good laboratory practices (GLP) are a set of standards for ensuring that laboratories deliver high-quality, reliable, and consistent data. Back in the 1970s–when standards weren’t enforced as much yet–errors and fraud in lab testing were much more common, so regulatory agencies like the US Food and Drug Administration (FDA) decided to develop GLP.
Today, GLP is already required for laboratories conducting safety studies on products to be submitted for regulatory approval. It also spans multiple industries:
- Pharmaceutical: Preclinical safety studies must comply with GLP for drugs to advance to further development.
- Food: GLP is critical for testing contaminants and ensuring products meet safety standards.
- Chemical: Through GLP, labs can create products that are safe for human use and for the environment.
GLP sets the bar for laboratory excellence. Today, labs are expected to generate data that can form the foundation for critical decisions, upholding safety and driving innovation further.
Components of good laboratory practices
As a comprehensive framework, GLP includes the following important components:
1. Standard operating procedures (SOPs)
Standard operating procedures are the foundation of good laboratory practices. These detailed, step-by-step instructions describe how to perform specific processes in the laboratory, from sample preparation to more complex testing.
Regulatory agencies like the FDA and OECD expect labs to have comprehensive SOPs in place. These serve as evidence that lab processes follow clearly defined steps and they can withstand scrutiny during audits and inspections.
2. Documentation and record-keeping
GLP requires laboratories to have accurate and thorough records of all processes. Key documents include:
- Laboratory notebooks
- Equipment calibration logs
- Test protocols
- Observation sheets
- Data analysis protocols
These records provide a clear paper trail that can be reviewed later on. Without proper documentation, any results may be dismissed because of a lack of transparency.
3. Quality assurance (QA) program
A quality assurance program serves as the lab’s internal monitoring system, with a dedicated team or department responsible for checking that each step of the workflow meets GLP standards. These are essential tasks:
- Overseeing processes
- Reviewing final reports
- Conducting routine audits to identify gaps
The QA team must conduct independent inspections of laboratory procedures and systems. These inspections may be unannounced, verifying that GLP requirements are followed consistently and not just selectively.
4. Personnel training and qualifications
Lab processes depend heavily on the expertise of people, so it’s essential for staff members to be properly trained and competent. This includes scientists, technicians, and support staff. In fact, labs should have detailed records of each employee’s training history, qualifications, and certifications.
On top of this, there must be comprehensive training programs for employees to understand GLP principles, laboratory procedures, and regulatory requirements. Staff must also be trained to follow standard operating procedures (SOPs).
5. Equipment and instrumentation management
For tools in the lab to work accurately, GLP requires laboratories to regularly calibrate, maintain, and validate their equipment to prevent errors.
In practice, equipment management involves:
- Creating and following a maintenance schedule
- Documenting calibration records
- Conducting routine performance checks
- Conduct validation before using new equipment
This applies to all tools, from high-tech analytical instruments to basic tools like pipettes and balances.
6. Sample collection and handling
GLP also includes strict protocols for how samples are collected, labeled, transported, stored, and processed to prevent contamination or mix-ups. With proper sample management, you can confidently trace back test results to the correct sample, which is crucial for data integrity.
Labs must follow proper labeling and documentation. Clearly label every sample with relevant information, such as its source, collection date, and storage conditions, to ensure full traceability.
7. Facilities and environment controls
At minimum, labs need to be organized, clean, and built properly for the type of work being conducted. For example, labs dealing with chemicals or biological materials must have separate areas for storage, testing, and waste disposal. The following factors must also be tracked and controlled to create a stable environment for experiments:
- Airflow
- Temperature
- Humidity
- Lighting
In fact, labs today often use environmental monitoring systems, ensuring that experiments are conducted under consistent conditions.
8. Test and study protocols
A protocol is a detailed plan that serves as a roadmap for a test or study so that it can be carried out systematically. It includes:
- The purpose of the study
- Materials and methods to be used
- Acceptance criteria for results
- Potential variables that need to be controlled
- Roles and responsibilities
According to GLP, laboratories must carefully develop, review, and approve protocols–before any testing can even begin. Once a protocol is finalized, it becomes the standard against which all activities and results are measured, so any deviations from the protocol must be documented and justified.
9. Audits and inspections
Audits and inspections are critical components of good laboratory practices.
Labs should conduct regular internal audits to assess if operations still align with established protocols, such as standard operating procedures (SOPs) and GLP requirements. External audits are often conducted by regulatory agencies or third-party organizations, and they provide an additional layer of accountability.
To prepare for audits and inspections, documentation should be thorough, accessible, and up-to-date, and personnel must be well-trained in following GLP protocols.
10. Data integrity and security
Data integrity refers to the completeness, accuracy, and consistency of data, from initial collection all the way to final reporting. Errors or unauthorized changes here can lead to serious consequences–like failed regulatory audits or the rejection of findings.
GLP requires labs to implement strict safeguards to prevent data tampering, whether intentional or accidental. This includes:
- Version control
- Audit trails
- Restricted access to data
Labs must also securely store records. For digital records, this may involve encryption, regular backups, and secure servers, while physical records must be stored in controlled environments that prevent deterioration.
Strategies for implementing good laboratory practices
To genuinely follow GLP, labs should focus on continuous improvement. Here are some strategies for taking your GLP compliance to the next level:
- Promote a “right first time” culture. This emphasizes doing things correctly from the start, minimizing errors and the need for rework. In a laboratory setting, every step—from experiment setup to documentation—should be carried out with accuracy and attention to detail.
- Leverage digital tools and checklists. Instead of relying on paper-based systems that are prone to human error, labs can adopt digital solutions such as mobile apps for real-time data entry. Tools like Lumiform also offer customizable checklists while automating repetitive processes and streamlining data collection.
- Perform root cause analysis (RCA) for non-conformities. When errors happen, simply fixing the immediate issue is not enough to maintain compliance with GLP. Labs need to identify the underlying cause of the problem. Tools for this include. the “5 Whys” method, fishbone diagrams, or failure mode and effects analysis (FMEA).
A digital tool for good laboratory practices
In laboratory environments, compliance with good laboratory practices (GLP) can be challenging without the right tools. Traditionally, safety officers and lab managers have relied on pen-and-paper methods for inspections and documentation. This approach is tedious and time-consuming, with much room for human error—especially when tracking compliance or producing reports.
You can avoid this hassle by moving to a digital application like Lumiform. The app and software solution specializes in making audits and inspections efficient and easy. Lumiform can be used by laboratories, schools, and universities worldwide to improve GLP compliance by:
- Capturing photographic evidence, annotating and attaching detailed notes on damage or repair needs in the lab.
- Identify issues and damage and immediately assign corrective actions to other teams within the organization via the app.
- Generate real-time lab inspection reports, anywhere, anytime – even offline. As soon as access to the internet is available, the data is automatically synchronized.
- Employees receive notifications of scheduled tests in the lab.
- Thanks to the comprehensive template library, you can get started digitally right away.
- All documents and reports are securely stored in the cloud.
Try Lumiform today with a 14-day free trial and experience how digital tools can transform your laboratory workflows!