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Good laboratory practices (GLP): A comprehensive guide

Good laboratory practices (GLP): A comprehensive guide

Author NameBy Ima Ocon
•
January 17th, 2025
• 9 min read
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Table of contents

  • What are good laboratory practices?
  • Components of good laboratory practices
  • Strategies for implementing good laboratory practices
  • A digital tool for good laboratory practices
Choose from our 10,000+ free, customizable templates.
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Summary

Good laboratory practices (GLPs) ensure labs produce reliable, consistent, and accurate results. This guide covers its core components as well as strategies for implementing GLP effectively.

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!

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Frequently asked questions

What’s the difference between good laboratory practices (GLP) and good manufacturing practices (GMP)?

Good laboratory practices (GLP) focuses on ensuring that laboratory studies are conducted with consistency and reliability. It governs preclinical testing, such as safety and efficacy studies for drugs, chemicals, or food additives. On the other hand, good manufacturing practices (GMP) apply to the production and distribution stages of manufacturing.

How do I identify gaps in good laboratory practices during day-to-day operations?

Start by observing workflows and comparing them to your SOPs. Look for inconsistencies between how processes are documented and how they’re actually carried out. For example, are calibration logs always completed? Is sample labeling clear and traceable? Conduct mini internal audits regularly to spot deviations early.

How do I prepare for unannounced regulatory inspections in a lab?

Maintain a “ready at all times” mindset by keeping documentation up to date and easily accessible. Assign specific roles during inspections—for example, designate someone to retrieve records quickly. Conduct mock inspections regularly to identify areas that might need attention, such as missing equipment logs.

Author
Ima Ocon
Ima is a writer and editor who specializes in technology, with experience crafting content for companies like Canva and FluentU. She's passionate about startups, remote work, and language learning, as well as the applications of AI in marketing. Currently, she is based in Asia, and she previously studied in Taiwan and Singapore.
Lumiform offers innovative software to streamline frontline workflows. With over 12,000 ready-to-use templates or custom digital forms, organizations can increase efficiency and automate key business processes. The platform is particularly user-friendly, offering advanced reporting capabilities and powerful logic functions that enable automated solutions for standardized workflows. Discover the transformative potential of Lumiform to optimize your frontline workflows. Learn more about the product

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