Good Laboratory Practice (GLP): Principles, Guidelines, Requirements, and Examples

Good Laboratory Practice (GLP) is a quality system that helps laboratories plan, perform, monitor, record, and report studies in a consistent and reliable manner. It focuses not only on laboratory testing but also on the people, facilities, equipment, procedures, records, and quality controls that support scientific work.

GLP is particularly important for non-clinical safety studies used to evaluate substances such as pharmaceuticals, chemicals, pesticides, cosmetics, and other products before regulatory decisions are made.

A well-implemented GLP system improves data integrity, traceability, accountability, and confidence in laboratory results.

What is GLP?

Good Laboratory Practice (GLP) is a set of principles designed to ensure that laboratory studies are properly planned, conducted, documented, monitored, and reported.

GLP establishes a structured quality framework for laboratory studies. It helps ensure that another qualified person can understand how a study was performed and determine how the reported results were obtained.

The main purpose of GLP is to protect the quality and integrity of study data.

A GLP-compliant laboratory generally controls several important areas, including:

• Organization and personnel
• Study planning and protocols
• Laboratory facilities
• Equipment and instruments
• Test and reference substances
• Standard operating procedures (SOPs)
• Study records and raw data
• Quality assurance
• Data handling
• Final reports
• Storage and archiving

GLP should not be confused with a laboratory’s ability to produce scientifically interesting results. Instead, it provides a controlled framework that makes study data reliable, traceable, and reproducible.

10 Good Laboratory Practice Principles

Good Laboratory Practice is built around a series of principles that control how non-clinical laboratory studies are organized, performed, documented, reported, and archived. Although the exact wording may differ between regulatory frameworks, the core GLP principles cover the following areas:

1. Test Facility Organization and Personnel
   The laboratory should have a clearly defined organizational structure, appropriate responsibilities, qualified personnel, and adequate training for assigned duties.
2. Quality Assurance Programme
   An independent quality assurance function should monitor study activities and verify that applicable GLP requirements, study plans, and procedures are being followed.
3. Facilities
   Laboratory facilities should be suitable for the studies being performed and designed to support proper testing while reducing risks such as contamination, interference, and sample mix-ups.
4. Apparatus, Materials, and Reagents
   Equipment, materials, reagents, and other laboratory resources should be suitable for their intended use. They should be properly identified, controlled, maintained, and stored, with appropriate records available.
5. Test Systems
   Test systems used in a study should be properly selected, maintained, identified, and controlled. Their condition and suitability should be documented where required so that they do not compromise the validity of the study.
6. Test and Reference Items
   Test and reference items should be correctly identified, characterized where required, handled appropriately, and stored under suitable conditions. Their receipt, use, storage, and disposition should remain traceable.
7. Standard Operating Procedures
   Routine laboratory activities should be performed according to current, approved SOPs. Procedures should be controlled, periodically reviewed, and updated when necessary.
8. Performance of the Study
   Studies should be conducted according to an approved study plan. Activities, observations, measurements, deviations, and other relevant information should be documented accurately and promptly.
9. Reporting of Study Results
   The final report should provide a complete and accurate account of the study, including relevant methods, results, deviations, interpretation, conclusions, and the applicable GLP compliance statement.
10. Storage and Retention of Records and Materials
    Required raw data, reports, protocols, specimens, samples, and other study-related materials should be securely archived and retained for the period required by applicable regulations.

Together, these principles create a controlled framework for maintaining the quality, integrity, traceability, and reliability of GLP study data throughout the study lifecycle.

Why is Good Laboratory Practice important?

Laboratory results can influence important decisions involving human health, environmental protection, product development, and regulatory approval. Poor documentation, inadequate equipment control, or unreliable records can therefore undermine an entire study.

GLP helps reduce these risks by establishing documented procedures and defined responsibilities.

The major benefits of GLP include:

1. Improved data integrity
   GLP helps ensure that study data are complete, accurate, and traceable.
2. Better consistency
   Standardized procedures reduce unnecessary variation between studies and laboratory personnel.
3. Greater accountability
   Defined responsibilities make it clear who performs, checks, approves, and reports each activity.
4. Regulatory confidence
   GLP provides a recognized framework for generating data used in regulatory submissions.
5. Better traceability
   Records allow laboratory personnel and auditors to trace results back to their original observations and procedures.
6. Reduced risk of errors
   Controlled procedures, equipment checks, training, and quality assurance help identify problems early.

GLP principles are especially associated with non-clinical health and environmental safety studies. Regulatory frameworks such as the U.S. FDA’s 21 CFR Part 58 and EPA GLP requirements provide formal GLP requirements for relevant studies.

GMP vs GLP

GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) are both quality systems, but they control different activities.

GLP and GMP can work together

A pharmaceutical organization may need both systems.

For example, a laboratory may use GLP when conducting a non-clinical safety study, while the manufacturing facility uses GMP when producing the pharmaceutical product.

Therefore, GLP does not replace GMP. Each system addresses a different part of the product and development lifecycle.

Do You Need to Comply with GLP?

Not every laboratory activity is automatically subject to Good Laboratory Practice (GLP). Whether GLP applies depends mainly on the purpose of the study, the type of product or test article, the regulatory requirements, and whether the resulting data are intended to support a regulatory submission.

In the United States, 21 CFR Part 58 applies to nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA. These products include human and animal drugs, biological products, medical devices, food and color additives, animal food additives, and certain electronic products.

When is GLP generally required?

GLP is generally relevant when a nonclinical safety study is conducted to generate data that will be submitted to a regulatory authority. FDA describes these studies as investigations in which test articles are studied under laboratory conditions to determine their safety.

Examples can include:

• Nonclinical toxicology and safety studies supporting regulated products
• Preclinical safety studies intended to support an FDA submission
• Certain animal drug safety studies
• Studies evaluating the safety of test articles in laboratory test systems
• Supporting analytical work that contributes data to a GLP-regulated nonclinical study
• Safety studies whose results are intended to form part of an application for a research or marketing permit

Contract laboratories and other organizations that perform services contributing to a regulated nonclinical study may also need to follow applicable GLP requirements for the work they perform.

When may GLP not apply?

Some laboratory activities fall outside the scope of FDA’s GLP regulations because they are not conducted as regulated nonclinical laboratory studies for the purposes specified in Part 58.

Examples identified in FDA’s GLP guidance and historical questions-and-answers include:

• Preliminary exploratory or screening studies used to investigate whether a test article has potential utility
• Basic research that is not being conducted as a regulated nonclinical safety study
• Certain method-development activities
• Some routine quality-control testing
• Certain analytical activities that do not contribute to a GLP-regulated safety study
• Clinical studies involving human subjects
• Animal field trials, which are excluded from the FDA definition of a nonclinical laboratory study

FDA has specifically stated that preliminary exploratory, screening, and range-finding work intended to develop or improve a later nonclinical laboratory study is not subject to its GLP regulations.

GLP Applicability: Practical Examples

FDA’s published GLP questions and answers provide specific examples of this distinction. For example, FDA states that GLP applies to certain animal health product safety studies and to specified analytical procedures that support a nonclinical safety study, while method-development work and certain cosmetic safety studies are outside the scope of its GLP regulations.

GLP During Drug Development

GLP is primarily associated with the nonclinical safety stage of product development. FDA describes preclinical research as the stage in which researchers evaluate potential harm, including toxicity, before a product is tested in humans. FDA requires applicable preclinical laboratory studies to follow the GLP requirements in 21 CFR Part 58.

However, it is important not to assume that every experiment performed during drug discovery must be GLP compliant. Exploratory research, screening, and other early-stage activities may fall outside the regulatory definition of a GLP-regulated nonclinical laboratory study. The applicability should be determined from the purpose and regulatory use of the study rather than simply from the stage of development.

How to Determine Whether GLP Applies

Before starting a study, organizations should consider the following questions:

1. What is the purpose of the study?
   Is it exploratory research, routine testing, or a formal nonclinical safety study?
2. What type of test article or product is involved?
   Different regulatory authorities may apply GLP requirements to different categories of products.
3. Will the study data support a regulatory submission?
   This is a major factor in determining whether regulated GLP requirements apply.
4. Which regulatory authority has jurisdiction?
   FDA, EPA, OECD-based national systems, and other authorities may have different scopes and requirements.
5. Are external laboratories involved?
   Work performed by contractors or specialist laboratories may also fall within GLP requirements when it contributes to a regulated study.
6. Are there study-specific exemptions or special provisions?
   Certain studies may require a different interpretation of individual GLP provisions.

The safest approach is to determine the applicable regulatory requirements before the study begins, document the decision, and ensure that all participating personnel and laboratories understand their responsibilities.

GLP Is Not a Universal Requirement for Every Laboratory

GLP should not be treated as a requirement for every laboratory test simply because the work involves chemicals, biological materials, animals, or sophisticated instruments. Its application depends on the regulatory purpose and scope of the study.

For example, a laboratory may conduct exploratory experiments during early research without being subject to FDA Part 58. The same organization may later conduct a regulated nonclinical safety study intended to support a regulatory submission, in which case the applicable GLP requirements would need to be followed.

Therefore, organizations should evaluate each study individually and determine the applicable regulatory framework, GLP requirements, and documentation expectations before work begins.

Definition of GLP Terms

Understanding common GLP terminology makes it easier to implement and audit a GLP system.

1. Test Facility

The organization or location where a GLP study or relevant part of a study is conducted.

2. Study Director

The individual responsible for the overall conduct of a study and for ensuring that the study follows the approved study plan and applicable GLP requirements.

3. Principal Investigator

A person who may be responsible for a defined phase of a study, particularly when different parts of a study are conducted at different locations.

4. Study Plan

A written document that describes the objectives, design, methods, procedures, and other important details of a planned study.

5. Standard Operating Procedure

A written instruction describing how a routine laboratory activity should be performed.

6. Raw Data

Original records and documentation generated during a study. These records provide evidence of the observations, measurements, and activities performed.

7. Quality Assurance Unit

An independent function that monitors laboratory activities to determine whether studies and procedures are being conducted according to applicable requirements.

8. Test Substance

A substance or material being investigated during a study.

9. Reference Substance

A substance used for comparison or control purposes in a study.

10. Protocol Deviation

A departure from an approved study plan or established procedure. Deviations should be appropriately documented, evaluated, and reported.

11. Final Report

The Study Director is responsible for ensuring that the final report provides a complete, accurate, and objective account of the study. The report should clearly describe how the study was conducted and present the results in a way that allows the work to be properly reviewed and evaluated.

A GLP final report should normally address the following:

• Study conduct: Describe the study objectives, methods, procedures, observations, and results sufficiently to provide a complete record of the work performed.
• Deviations: Identify and explain any departures from the approved study plan, protocol, SOPs, or other established procedures. Where appropriate, their potential impact on the study should also be considered.
• Results and scientific interpretation: Present the study findings clearly and provide a scientifically sound interpretation of the results. Significant observations and their relevance to the study objectives should be discussed.
• GLP compliance statement: Include a statement from the Study Director indicating whether the study was conducted in accordance with the applicable GLP requirements and identifying any relevant areas of non-compliance.
• Conclusions: State the conclusions supported by the study data without introducing information that is not justified by the results.

The final report should undergo the required review and approval process before it is finalized. Any subsequent changes should be controlled and documented so that the original report, the reason for the change, and the person responsible remain traceable.

A properly prepared final report therefore serves as more than a summary of results. It provides a complete and traceable record of the study, linking the planned work, actual activities, deviations, data, scientific interpretation, and conclusions.

12. Storage of Records

GLP records should be stored in a controlled archive throughout the required retention period. The archive should protect study-related information from loss, damage, unauthorized access, alteration, and premature destruction.

The Study Director has an important responsibility for ensuring that study data and supporting documentation are properly maintained during the study. At the end of the study, applicable records should be transferred to the designated archive in accordance with the laboratory’s document-control procedures.

Archived materials may include:

• Approved study plans and amendments
• Raw data and original observations
• Standard operating procedures
• Final reports
• Quality assurance records
• Equipment and calibration records
• Training records
• Test and reference substance records
• Other documents and materials required by the applicable GLP regulations

Access to archived records should be limited to authorized personnel. The laboratory should maintain appropriate controls to prevent unauthorized removal, modification, or destruction of archived information.

A record should also be maintained when archived material is accessed, removed, or returned. This tracking system can identify who accessed the record, when it was accessed, what was removed, and when it was returned, where applicable.

Archived records should be properly indexed and organized so that authorized personnel can locate and retrieve them efficiently. Electronic archives should use appropriate access controls, backup measures, and data-integrity safeguards.

These controls help maintain the security, traceability, availability, and integrity of GLP records throughout their required retention period.

13. Retention of Records

Archiving a GLP record is not enough; the laboratory must also retain it for the period required by the applicable regulations. The retention period can vary according to the type of study, regulatory authority, and whether the study data were submitted as part of a regulatory application.

In the United States, 21 CFR Part 58, Subpart J establishes requirements for retaining records and other study-related materials generated during nonclinical laboratory studies. These requirements cover items such as raw data, study documentation, protocols, final reports, and certain specimens.

For FDA-regulated studies, laboratories should determine the applicable retention period based on the status and purpose of the study. Important considerations include:

• Studies submitted to the FDA: Determine the applicable retention period based on the regulatory application and the provisions of 21 CFR § 58.195.
• Studies supporting an IND or IDE: Apply the specific retention provisions that govern records associated with these submissions.
• Studies supporting a research or marketing permit: Records are subject to the retention periods specified under the applicable FDA requirements.
• Studies that are not submitted to the FDA: Records generally need to be retained for the period specified by the regulation after the study has been completed, terminated, or discontinued.

The retention requirement may also apply to quality assurance records, personnel training and qualification records, equipment maintenance and calibration records, and other documents required by the GLP regulations.

A laboratory should maintain an effective archive system that protects records from loss, deterioration, unauthorized access, accidental destruction, or inappropriate modification. Archived information should remain identifiable and readily retrievable throughout the required retention period.

Before disposing of an archived record, the laboratory should verify that:

• The applicable retention period has expired.
• No regulatory requirement requires longer retention.
• No ongoing investigation, audit, inspection, or legal requirement requires the record to be preserved.
• The record is not subject to a sponsor or organizational retention requirement that extends beyond the minimum regulatory period.
• The disposal process is documented and appropriately authorized.

Because GLP requirements differ among countries and regulatory authorities, laboratories should not assume that one retention period applies to every study. The applicable national regulations and study-specific requirements should always be reviewed before records are destroyed.

Good Laboratory Practice Guidelines

GLP guidelines provide a framework for controlling the entire study lifecycle.

Although exact requirements vary between regulatory systems, the major principles generally include the following areas.

1. Organization and Personnel

The laboratory should have a clearly defined organizational structure.

Personnel should understand:

• Their responsibilities
• Reporting relationships
• Required qualifications
• Training requirements
• Study-specific responsibilities
• Applicable laboratory procedures

Personnel should receive appropriate training before performing assigned activities.

2. Quality Assurance

An effective GLP system requires independent quality oversight.

The Quality Assurance function should monitor laboratory activities and verify that applicable procedures and study requirements are being followed.

Quality assurance activities can include:

• Reviewing SOPs
• Inspecting study activities
• Reviewing study documentation
• Checking reports
• Recording findings
• Following up on corrective actions

3. Facilities

Laboratory facilities should be suitable for the studies being performed.

Facilities should provide adequate space and appropriate environmental conditions while minimizing the risk of contamination, interference, or mix-ups.

Where necessary, separate areas may be provided for:

• Test systems
• Test substances
• Sample preparation
• Equipment
• Storage
• Waste
• Records and archives

4. Equipment

Laboratory equipment should be appropriate for its intended purpose.

Important controls include:

• Identification
• Calibration
• Maintenance
• Cleaning
• Inspection
• Performance verification
• Service records

Equipment problems should be documented and evaluated for their potential impact on study data.

5. Standard Operating Procedures

SOPs provide consistent instructions for routine laboratory activities.

An SOP may cover activities such as:

• Sample handling
• Instrument operation
• Equipment maintenance
• Calibration
• Cleaning
• Data recording
• Computerized systems
• Waste management
• Archiving

SOPs should be controlled, reviewed, approved, and updated when necessary.

6. Study Plan

A study should be properly planned before work begins.

The study plan normally identifies the study objectives, test materials, methods, test systems, observations, measurements, and reporting requirements.

Changes to the approved plan should be appropriately documented and justified.

7. Test and Reference Substances

Test and reference substances should be properly identified, handled, stored, and documented.

Records should allow personnel to determine what substance was used, where it came from, how it was stored, and how it was used during the study.

8. Data Recording

Laboratory personnel should record observations and measurements accurately and promptly.

Records should be:

• Clear
• Complete
• Traceable
• Accurate
• Legible
• Secure
• Protected from unauthorized changes

Electronic records require appropriate controls to protect data integrity.

9. Reporting

The final report should accurately represent the study.

It should provide sufficient information about the study methods, results, deviations, and conclusions so that the work can be properly evaluated.

10. Archiving

Important study records and supporting materials should be retained according to applicable requirements.

Proper archiving protects records against loss, damage, unauthorized alteration, or premature destruction.

Good Laboratory Practice Examples

Good Laboratory Practice becomes easier to understand when its principles are connected to everyday laboratory activities. The following examples illustrate how GLP requirements can be applied in practical situations.

Example 1: Using and Maintaining Laboratory Equipment

A laboratory should select equipment that is suitable for the intended task and operate it according to approved procedures. Equipment should be uniquely identified, routinely inspected, calibrated when required, and maintained in a controlled manner.

For example, an analytical balance used to measure test materials should have current calibration records and a documented maintenance history. If the balance produces results outside established acceptance limits, the laboratory should investigate the issue and determine whether previously generated study data could have been affected.

Example 2: Proper Sample Identification

Laboratories may handle a large number of samples during a study. Each sample should therefore have a clear and unique identification system.

The identification should allow personnel to follow the sample through relevant stages such as receipt, preparation, testing, storage, and final disposition. Proper labeling and tracking help prevent sample mix-ups and strengthen traceability.

Example 3: Following Approved Procedures

Personnel should perform routine laboratory activities according to current, approved SOPs and study-specific instructions.

For example, an analyst preparing a test solution should follow the applicable procedure rather than relying on memory or an outdated document. Controlled procedures help different personnel perform the same activity consistently.

Example 4: Maintaining a Safe Working Environment

Good laboratory practices also include maintaining appropriate workplace safety during laboratory activities. Personnel should use the required personal protective equipment (PPE), follow applicable safety procedures, handle substances appropriately, and keep work areas clean and orderly.

Employees should also be trained to recognize potential hazards and report unsafe conditions, spills, equipment problems, or unfamiliar substances through the laboratory’s established reporting process.

Example 5: Responding to Instrument Failure

Laboratory equipment can occasionally malfunction during a study. When this happens, personnel should document the problem rather than simply continuing the work without evaluation.

The laboratory should determine which activities or data may have been affected, take appropriate corrective action, and assess whether the incident could influence the reliability of the study results.

Example 6: Correcting Laboratory Records

Errors in laboratory records should be corrected in a controlled and traceable manner.

For example, if an analyst enters an incorrect value in a handwritten record, the original entry should remain readable. The correction should identify the revised information and include the appropriate date, reason, and identification of the person making the change, according to the laboratory’s approved procedure.

Electronic records should likewise be corrected using controlled processes that preserve the relevant history and maintain data integrity.

Example 7: Maintaining Personnel Training

Personnel should receive appropriate training before performing GLP-related activities independently.

Training records should demonstrate the training completed by an employee and provide evidence that the person is appropriately qualified for assigned responsibilities. Refresher training should be provided when procedures, equipment, responsibilities, or applicable requirements change.

Example 8: Reporting Deviations

If laboratory personnel depart from an approved study plan, SOP, or other established procedure, the deviation should be documented and evaluated.

For example, if a required test condition cannot be maintained because of an equipment problem, the event should be recorded, investigated, and assessed for its potential effect on the study.

Example 9: Protecting Laboratory Data

GLP requires more than producing a laboratory result. The laboratory should also be able to demonstrate how the result was generated.

Personnel should record observations promptly and maintain complete and traceable records. Access to electronic systems should be appropriately controlled, while backups, audit trails where applicable, and other data-integrity measures should be implemented according to the laboratory’s procedures.

Example 10: Controlled Storage and Archiving

At the completion of a study, required records should be transferred to a controlled archive. Records should be organized so that authorized personnel can retrieve them when needed.

The archive should protect study documents, raw data, reports, and other required materials from loss, damage, unauthorized access, alteration, or premature destruction.

These examples show that GLP is not limited to paperwork or regulatory inspections. It becomes part of routine laboratory work through proper equipment control, safe working practices, sample traceability, personnel training, accurate documentation, data protection, deviation management, and controlled archiving.

GLP Requirements

Although specific regulatory requirements differ, a functioning GLP system generally needs controls across several key areas.

Data Integrity in GLP

Data integrity is one of the most important aspects of Good Laboratory Practice.

Laboratory data should remain trustworthy throughout their lifecycle. This includes the creation, recording, processing, review, reporting, storage, and eventual retention or disposal of data.

A GLP laboratory should therefore establish controls for:

• User access
• Data entry
• Data review
• Electronic records
• Audit trails where applicable
• Corrections
• Backups
• Record retention
• Change control

The goal is not simply to generate a result. The laboratory must also be able to demonstrate how that result was generated.

How GLP Training Can Help You Implement Workplace Best Practices

GLP training helps laboratory personnel understand both the principles and practical responsibilities associated with a quality system.

Effective training should explain how GLP requirements apply to everyday laboratory work.

Important training topics may include:

• GLP principles
• Personnel responsibilities
• Study plans
• SOPs
• Documentation
• Data integrity
• Equipment control
• Sample handling
• Deviations
• Quality assurance
• Corrective and preventive actions
• Reporting
• Archiving

Training should also be appropriate to an employee’s role.

For example, laboratory analysts may need detailed training on data recording and equipment use, while study directors may require additional training on study management, deviations, reporting, and overall compliance.

Regular refresher training can help reinforce good practices and address changes in procedures or regulatory expectations.

Good Laboratory Practice Templates

Laboratories can use controlled templates to standardize documentation and reduce the risk of missing important information.

Useful GLP templates may include:

• Study plan template
• SOP template
• Training record
• Equipment calibration record
• Equipment maintenance log
• Sample receipt form
• Sample tracking log
• Test substance record
• Deviation form
• Corrective action record
• Quality assurance inspection checklist
• Study report template
• Archive inventory
• Document change-control form

Templates should be controlled documents rather than informal forms. The laboratory should establish appropriate version control, approval, review, and retention procedures.

GLP Audit Checklist

A GLP audit can help identify weaknesses before they become significant compliance problems.

A basic checklist may include:

Organization and Personnel

• Are responsibilities clearly defined?
• Are personnel appropriately qualified?
• Are training records maintained?
• Are roles and reporting relationships documented?

Facilities

• Are laboratory areas suitable for their intended use?
• Are storage areas adequately controlled?
• Is contamination or mix-up adequately prevented?

Equipment

• Is equipment uniquely identified?
• Is calibration current?
• Are maintenance records available?
• Are equipment failures documented?

Documentation

• Are SOPs current and approved?
• Are obsolete versions controlled?
• Are records complete and traceable?

Study Management

• Is an approved study plan available?
• Are deviations documented?
• Are study activities performed according to approved procedures?

Data Integrity

• Are original records retained?
• Are corrections traceable?
• Are electronic records appropriately controlled?
• Are access rights properly managed?

Quality Assurance

• Is quality assurance independent?
• Are inspections documented?
• Are findings communicated?
• Are corrective actions followed up?

Reporting and Archiving

• Does the final report accurately represent the study?
• Are required records archived?
• Can study data be retrieved when needed?

Advantages of Good Laboratory Practice

Implementing GLP can provide several long-term benefits.

Reliable Laboratory Data

A structured quality system improves confidence in laboratory observations and results.

Better Traceability

Documentation makes it easier to trace results to samples, equipment, procedures, personnel, and original records.

Consistent Laboratory Operations

SOPs and controlled procedures help personnel perform routine activities consistently.

Improved Regulatory Readiness

A properly documented GLP system can help laboratories demonstrate compliance when their studies are subject to regulatory oversight.

Reduced Risk

Equipment controls, training, quality assurance, and documented procedures help reduce operational and data-quality risks.

Improved Accountability

Clearly assigned responsibilities make it easier to identify who performed and reviewed particular activities.

GLP vs ISO 17025

GLP and ISO/IEC 17025 are sometimes confused because both involve laboratory quality.

However, they serve different purposes.

GLP primarily addresses the quality and integrity of regulated non-clinical study processes and data, while ISO/IEC 17025 establishes requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories.

A laboratory may therefore use one or both frameworks depending on its activities and regulatory obligations.

The appropriate quality system should always be determined according to the laboratory’s purpose, applicable regulations, and customer or regulatory requirements.

Common GLP Mistakes

Laboratories may experience compliance problems when GLP principles are treated only as documentation requirements.

Common mistakes include:

• Performing work without an approved procedure
• Using outdated SOPs
• Inadequate personnel training
• Missing equipment calibration
• Poor sample identification
• Incomplete raw data
• Uncontrolled data corrections
• Failure to document deviations
• Inadequate quality assurance
• Poor record retention
• Weak electronic data controls
• Incomplete final reports

The solution is to integrate GLP into daily laboratory operations rather than treating it as an occasional audit exercise.

How to Implement Good Laboratory Practice

A practical GLP implementation process can follow these steps:

Step 1: Assess Current Laboratory Practices

Review existing procedures, documentation, equipment controls, training, data systems, and quality processes.

Step 2: Identify Applicable Requirements

Determine which GLP regulations, guidelines, and regulatory expectations apply to the laboratory and its studies.

Step 3: Define Responsibilities

Clearly assign responsibilities for study direction, laboratory activities, quality assurance, equipment management, documentation, and archiving.

Step 4: Develop and Control SOPs

Create procedures for routine laboratory activities and establish document-control processes.

Step 5: Train Personnel

Train employees according to their roles and maintain appropriate training records.

Step 6: Control Equipment

Establish procedures for identification, calibration, maintenance, inspection, and use of laboratory equipment.

Step 7: Strengthen Data Integrity

Control paper and electronic records throughout their lifecycle.

Step 8: Establish Quality Assurance

Implement independent monitoring and inspection activities.

Step 9: Conduct Internal Audits

Regularly evaluate laboratory practices against applicable GLP requirements.

Step 10: Correct and Prevent Problems

Document findings, investigate their causes, implement corrective actions, and verify their effectiveness.

Conclusion

Good Laboratory Practice (GLP) provides a systematic approach for ensuring the quality, reliability, integrity, and traceability of laboratory study data. It covers much more than laboratory testing itself. Personnel, facilities, equipment, SOPs, study plans, raw data, quality assurance, reporting, and archiving all form important parts of a GLP system.

For laboratories involved in regulated non-clinical studies, effective GLP implementation can improve confidence in study results and support regulatory acceptance. The strongest GLP systems integrate quality principles into everyday laboratory activities rather than relying only on inspections or audits.

By combining appropriate training, controlled procedures, reliable equipment, accurate documentation, data-integrity controls, independent quality assurance, and proper archiving, organizations can build a laboratory environment that consistently produces trustworthy and traceable data.

FAQs about Good Laboratory Practice

Read Next:

1. GMP: Good Manufacturing Practices – Meaning, Components, Principles & Compliance
2. Data Collection Techniques: Definition, Types, Methods & Applications
3. Complete Guide to EHS Compliance