# GLP Good Laboratory Practice: A Practical Guide for Industry Scientists ## Introduction to GLP Good Laboratory Practice Good Laboratory Practice (GLP) is a formal quality system that governs the organizational processes and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. GLP is not a scientific framework—it does not dictate experimental design or the validity of a particular assay. Rather, it is a managerial framework that ensures the *integrity* and *reproducibility* of the data generated, such that regulatory authorities can confidently rely on those data for risk assessment and product approval decisions. ### Definition and Objectives The term "Good Laboratory Practice" was codified in the 1970s in response to a series of investigations by the US Food and Drug Administration (FDA) that uncovered widespread fraudulent practices and poor data quality in toxicology laboratories. The resulting regulations, published in 1978 (21 CFR Part 58), established the foundational requirement: studies submitted to the FDA in support of a research or marketing permit must be conducted under a defined set of standards covering facilities, personnel, equipment, protocols, record-keeping, and quality assurance. The core objective of GLP is **data integrity**. A study conducted under GLP produces data that are: - **Attributable** — every data point can be traced to the individual who generated it, the instrument used, and the time of generation. - **Legible** — records are permanent and readable. - **Contemporaneous** — entries are made at the time of the activity. - **Original** — the raw data are preserved, not transcribed or altered. - **Accurate** — records reflect the true observation, with no undocumented corrections. These five attributes, often abbreviated as ALCOA, form the operational heart of GLP. The system exists to answer one question for a regulator: *Can you prove that this study was done exactly as reported, and that the results are genuine?* ### Regulatory Framework (OECD, FDA, EPA) GLP is not a single global standard. The three principal frameworks you will encounter in industry are: | Framework | Issuing Body | Scope | Key Document | |-----------|-------------|-------|--------------| | OECD GLP | Organisation for Economic Co-operation and Development | International mutual acceptance of data (42+ member countries) | OECD Series on Principles of GLP, No. 1 (ENV/MC/CHEM(98)17) | | FDA GLP | US Food and Drug Administration | Non-clinical safety studies supporting IND/NDA submissions | 21 CFR Part 58 | | EPA GLP | US Environmental Protection Agency | Pesticide and toxic substance studies under FIFRA and TSCA | 40 CFR Part 160 (FIFRA) and 40 CFR Part 792 (TSCA) | The OECD framework is the most widely adopted internationally. Its key advantage is **Mutual Acceptance of Data (MAD)**: a study conducted under OECD GLP in one member country is accepted by regulatory authorities in all other member countries, eliminating the need for duplicate testing. The FDA and EPA frameworks are largely harmonized with OECD principles but contain US-specific requirements, particularly regarding facility inspection procedures and the role of the Quality Assurance Unit. For a working scientist, the practical implication is this: if your laboratory supports studies destined for regulatory submission, you must know which framework applies. A study conducted to OECD GLP for a European submission will generally satisfy FDA requirements, but the reverse is not always true without careful gap analysis. When in doubt, design your systems to meet the most stringent requirements across all applicable frameworks. ## Core Principles of GLP The OECD GLP principles enumerate ten fundamental requirements. These are not abstract ideals—each maps to concrete operational obligations that you must implement in your laboratory. ### Organization and Personnel **Study Director** — The single point of control for each study. The Study Director has overall responsibility for the technical conduct of the study, interpretation of results, and the final report. This individual must have the appropriate education, training, and experience, and must be identified in the study plan. Critically, the Study Director is the only person who can authorize deviations from the approved study plan. **Principal Investigator** — In multi-site studies, the Principal Investigator acts on behalf of the Study Director at a specific test site. If your laboratory serves as a contract research organization (CRO) conducting a defined portion of a larger study, you will likely function under a Principal Investigator. **All personnel** — Every individual involved in the study must have documented training records (current CV, job description, and training logs) demonstrating they are qualified for their assigned tasks. Personnel must also follow health precautions to minimize risk to themselves and to the integrity of the study—for example, wearing appropriate PPE to prevent contamination of test systems. ### Quality Assurance Program The Quality Assurance Unit (QAU) is an independent group, separate from study conduct personnel, that monitors study compliance. The QAU does not perform the science; it verifies that the science is performed according to the study plan and SOPs. Key obligations of the QAU include: - Maintaining a master schedule of all studies conducted at the facility. - Conducting inspections at intervals adequate to assure the integrity of the study. - Reviewing the final report for accuracy and compliance. - Reporting findings to management and the Study Director. The QAU must be **functionally independent**—it cannot report through the same management chain as the scientists conducting the studies. In a small organization, this may mean designating a dedicated QA officer who has no other operational duties. ### Facilities and Equipment Facilities must be designed to minimize contamination risks and to provide adequate separation of test systems. For example, a laboratory conducting both *in vivo* and *in vitro* studies must have physically separate areas for animal housing and analytical work. Environmental controls (temperature, humidity, light cycles) must be monitored and recorded, with alarms for excursions. Equipment requirements are straightforward but exacting: - **Calibration** — instruments must be calibrated at defined intervals using traceable standards. For example, an analytical balance must be calibrated daily with certified weights, and the calibration must be documented. - **Maintenance** — preventive maintenance must follow a written schedule, with records retained. - **Documentation** — each piece of equipment must have a logbook recording usage, calibration, maintenance, and any malfunctions. A common practical point: if you use a PCR thermocycler in a GLP study, you must have documentation that the block temperature was verified within a defined tolerance (typically ±0.5°C) at the time of use, and that the verification was performed using a calibrated thermometer. ### Standard Operating Procedures (SOPs) SOPs are the backbone of GLP. Every routine operation—from animal husbandry to pipette calibration to data entry—must have a written, approved SOP. The requirements are: - **Approval** — each SOP must be signed and dated by authorized personnel (typically the facility manager and the QAU). - **Version control** — a master list must track current versions; obsolete versions must be removed from active use and archived. - **Availability** — current SOPs must be readily accessible at the work site. - **Training** — personnel must be trained on each SOP relevant to their duties, and that training must be documented. SOPs should be written at a level of detail that allows a trained individual to perform the task without verbal instruction. For example, an SOP for [buffer preparation](/knowledge/molecular-biology/buffer-preparation) should specify the exact components, concentrations, pH adjustment method, and storage conditions. A good rule of thumb: if two different scientists could interpret the instruction differently, the SOP is not detailed enough. ## Study Planning and Conduct ### Study Plan and Protocol Every GLP study begins with a written **study plan** (also called a protocol). This document, approved and dated by the Study Director, defines the entire scope of the study before any experimental work begins. The study plan must include: 1. A descriptive title and statement of purpose. 2. Identification of the test item (the compound or material being studied) and reference item (the control). 3. Name and address of the sponsor and test facility. 4. The proposed experimental start and completion dates. 5. Justification for the chosen test system (e.g., species, cell line, or in vitro model). 6. A detailed description of the experimental design, including methods, controls, and [statistical analysis](/blog/guides/statistical-analysis) to be used. 7. Description of the records to be maintained. The study plan is a contract between the Study Director and the regulatory expectation. **Any deviation from the approved plan must be documented as a signed, dated amendment** before the deviation occurs, or as a deviation report if it occurs unexpectedly during the study. ### Conduct of the Study During the in-life phase, the study must be conducted exactly as described in the study plan and SOPs. Key operational requirements include: - **Test item characterization** — the identity, purity, stability, and concentration of the test item must be documented. For example, if you are dosing cells with a small molecule inhibitor, you must have analytical data (e.g., HPLC purity ≥ 98%, NMR confirmation) on the batch used. - **Test system preparation** — animals must be acclimated, cell lines must be tested for mycoplasma contamination, and all conditions must be documented. - **Contemporaneous recording** — all observations must be recorded at the moment they are made, in permanent ink, in bound notebooks or validated electronic systems. If you are working with a physical notebook, follow [Good Laboratory Notebook Practices](/knowledge/molecular-biology/good-laboratory-notebook-practices) to ensure your entries meet GLP standards. A critical nuance: **raw data** are defined as the original records of the study. For a spectrophotometric assay, the raw data are the instrument printout or the electronic trace file, not the transcribed values in your notebook. You must preserve the original output and ensure it is traceable to the sample and the analyst. ### Raw Data and Documentation Raw data must be: - **Identified** — each page or electronic record must include the study number, test system identification, and date. - **Corrected properly** — errors in handwritten records must be corrected by a single line through the error, the correction written alongside, and the change initialed and dated. White-out, erasure, or overwriting is strictly prohibited. - **Traceable** — for electronic data, the audit trail must capture the original entry, the modified entry, the time of modification, and the identity of the individual making the change. For [molecular biology](/blog/careers/molecular-biology) laboratories, a common challenge is the use of shared equipment with electronic outputs. If your gel imager or qPCR instrument generates electronic files, those files must be stored on a validated system with restricted access and a functional audit trail. A practical approach is to configure the instrument software to save files to a network drive with write-protection for all users except the system administrator. ## [Data Management](/blog/guides/data-management-basics-principles-processes-and-best-practices) and Reporting ### Data Integrity and Traceability Data integrity under GLP extends beyond the ALCOA principles to encompass the **data lifecycle**: from generation, through processing and analysis, to archival. The key operational requirements are: - **21 CFR Part 11 compliance** (for FDA-regulated studies) — electronic records must have controlled user access, audit trails, and electronic signatures that are unique to each individual. - **Data ownership** — the test facility must have a documented process for data transfer, ensuring that data generated at one site (e.g., a contract analytical laboratory) are transmitted securely and without alteration to the Study Director. - **[Statistical analysis](/blog/guides/statistical-analysis)** — the [statistical methods](/blog/guides/statistical-methods) must be specified in the study plan, and the analysis must be performed using validated software. For example, if you plan to use a two-way ANOVA with post-hoc Tukey correction, the software version and analysis parameters must be documented. A practical point about **spreadsheet use**: Microsoft Excel is not inherently GLP-compliant for data analysis unless you implement controls. The file must be password-protected, the calculation cells must be locked, and the audit trail (via the "Track Changes" feature or a validated add-in) must be enabled. Many laboratories find it simpler to use dedicated statistical software (e.g., SAS, JMP, or GraphPad Prism with audit trail enabled) for GLP studies. ### Archiving and Retention GLP requires that all raw data, documentation, protocols, final reports, and samples be archived at the completion of the study. The archive must be: - **Secure** — with controlled access, fire protection, and environmental monitoring (temperature and humidity). - **Organized** — with an indexing system that allows rapid retrieval. - **Retained for a defined period** — typically at least 5 years for FDA studies, but many sponsors require 10–15 years or longer. Check your sponsor agreement. The archive is a common point of failure in GLP compliance. If you are establishing an archive, consider the [Duplicate Laboratory Notebook Best Practices](/knowledge/molecular-biology/duplicate-laboratory-notebook-best-practices) guidance for ensuring that critical records are backed up in a separate location. ### Final Report and Signatures The final report is the definitive record of the study. It must include: - The study title and identification number. - Names of the Study Director, Principal Investigators, and all scientists involved. - A description of the test and reference items. - The experimental start and completion dates. - A description of the materials and methods, including [statistical methods](/blog/guides/statistical-methods). - The results, presented as tables, figures, and narrative. - A discussion and conclusion. - Storage location of raw data and samples. The final report must be **signed and dated by the Study Director**, who takes responsibility for the accuracy and completeness of the report. The QAU must also sign, certifying that the study was conducted in compliance with GLP and that the report accurately reflects the raw data. If a study is found to have significant deviations from GLP, the report must include a statement describing those deviations and their impact on the study. ## Quality Assurance and Audits ### QA Inspections The Quality Assurance Unit conducts three types of inspections: 1. **Study-based inspections** — performed during the conduct of a specific study, at critical phases (e.g., dosing, sample collection, data analysis). 2. **Facility-based inspections** — performed to assess the general compliance of the facility, including equipment maintenance, SOP adherence, and personnel training. 3. **Process-based inspections** — performed on specific procedures that are used across multiple studies (e.g., animal husbandry, histopathology processing). The QAU must document each inspection, including the date, the phase of the study inspected, the findings, and any actions taken. These inspection records must be available for regulatory review. ### Audit Process A regulatory audit (e.g., by the FDA or a national GLP monitoring authority) is a formal inspection of your facility, records, and processes. The audit typically follows a defined sequence: 1. **Pre-audit preparation** — the inspector reviews the master schedule and selects one or more studies for detailed review. 2. **Facility tour** — the inspector verifies that the physical facilities match the descriptions in the study plan and SOPs. 3. **Records review** — the inspector examines raw data, SOPs, training records, equipment logs, and the final report for consistency. 4. **Personnel interviews** — the inspector may question scientists about their specific duties and their understanding of the procedures they performed. 5. **Exit meeting** — the inspector presents preliminary findings, which are categorized as: - **No findings** — full compliance. - **Minor deficiencies** — isolated errors that do not affect data integrity. - **Major deficiencies** — systemic problems that may affect data integrity. - **Critical deficiencies** — data integrity is compromised; the study may be rejected. The best defense in an audit is a well-maintained, self-audited facility. Conduct internal audits at least annually, using the same checklists that regulatory inspectors use. ### Corrective and Preventive Actions (CAPA) When an inspection (internal or external) identifies a deficiency, the facility must implement a **CAPA** process: 1. **Identify the root cause** — use a structured method such as the "5 Whys" or a fishbone diagram. 2. **Define the corrective action** — the immediate fix to address the specific finding. 3. **Define the preventive action** — the systemic change to prevent recurrence (e.g., revising an SOP, retraining staff, or upgrading equipment). 4. **Verify effectiveness** — document that the CAPA resolved the issue and did not introduce new problems. CAPA records must be maintained and made available for regulatory inspection. A robust CAPA process demonstrates to regulators that your facility has a culture of continuous improvement, which can significantly mitigate the impact of minor findings. ## GLP vs GMP vs GCP ### Key Differences GLP, Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) are three distinct quality systems that apply at different stages of the product lifecycle. The table below summarizes the key differences: | Attribute | GLP | GMP | GCP | |-----------|-----|-----|-----| | **Stage** | Non-clinical (preclinical) | Manufacturing and quality control | Clinical trials in humans | | **Primary focus** | Data integrity and study conduct | Product quality and consistency | Patient safety and ethical conduct | | **Key regulatory basis** | OECD GLP, 21 CFR Part 58 | 21 CFR Parts 210/211, ICH Q7 | ICH E6 (R2), 21 CFR Parts 50, 56, 312 | | **Unit of analysis** | The study | The batch/lot | The trial/patient | | **Core documents** | Study plan, raw data, final report | Batch records, deviation reports, COAs | Protocol, informed consent, case report forms | | **Quality oversight** | Quality Assurance Unit (QAU) | Quality Control (QC) and Quality Assurance (QA) | Clinical Quality Assurance (CQA) | | **Primary question** | "Was the study conducted as reported?" | "Was the product manufactured consistently to specification?" | "Were the rights, safety, and well-being of subjects protected?" | ### When Each Applies The three systems are sequential in the drug development timeline. A candidate compound is first tested in non-clinical safety studies under GLP to establish its toxicological profile. If the data support proceeding, the compound is manufactured under GMP for use in clinical trials, which are conducted under GCP. The GLP data, GMP batch records, and GCP clinical data are all submitted together in the regulatory filing (e.g., an IND, NDA, or MAA). For a scientist in a [molecular biology](/blog/careers/molecular-biology) laboratory, the most relevant distinction is between GLP and GMP. If you are developing an assay to support a toxicology study, you work under GLP. If you are producing a recombinant protein for use as a therapeutic, you work under GMP. The two systems have different documentation requirements: GLP emphasizes the study plan and raw data, while GMP emphasizes batch records and deviation management. A laboratory that performs both functions must maintain separate SOPs and quality systems for each. ## Implementing GLP in Your Laboratory ### Gap Analysis Transitioning a research laboratory to GLP compliance is a significant undertaking. The first step is a **gap analysis**: a systematic comparison of your current practices against the GLP requirements. The analysis should cover: 1. **Personnel** — do you have documented training records for all staff? 2. **Facilities** — are your laboratory areas adequately separated and environmentally controlled? 3. **Equipment** — is all equipment calibrated and maintained with documented logs? 4. **SOPs** — do you have written SOPs for all routine procedures? 5. **Data management** — are your electronic records secure, with audit trails? 6. **Quality assurance** — do you have an independent QAU function? 7. **Archiving** — do you have a secure, organized archive with defined retention periods? The gap analysis should produce a prioritized list of actions, with the most critical gaps (those affecting data integrity) addressed first. ### Training and Culture GLP compliance is a cultural shift, not just a documentation exercise. Scientists who are accustomed to the flexibility of research laboratories must adapt to a mindset where every action is documented and every deviation is reported. Key training elements include: - **Initial GLP training** — a comprehensive course covering the principles of GLP, the regulatory framework, and the consequences of non-compliance. - **Role-specific training** — Study Directors need training on study plan development and deviation management; analysts need training on raw data documentation and electronic record keeping. - **Refresher training** — annual updates on regulatory changes and lessons learned from internal audits. A practical tip: integrate GLP training into your laboratory's existing onboarding process, and pair new staff with experienced mentors who model compliant behavior. The [Recombinant Protein Laboratory](/knowledge/molecular-biology/recombinant-protein-laboratory) environment is a good example of a setting where GLP principles can be embedded into daily workflows. ### SOP Development and Management SOP development is often the most time-consuming part of GLP implementation. A practical approach is to: 1. **Inventory existing procedures** — list all routine operations in your laboratory. 2. **Prioritize** — start with the SOPs that are most critical to data integrity (e.g., sample handling, instrument calibration, data entry). 3. **Draft** — write each SOP in a standard template with sections for purpose, scope, responsibilities, materials, procedure, and documentation. 4. **Review and approve** — have the SOP reviewed by the scientists who will use it, then approved by management and the QAU. 5. **Train and implement** — train all relevant personnel and document the training. 6. **Review periodically** — establish a review cycle (typically every 2–3 years) to ensure SOPs remain current. A common mistake is writing SOPs that are too generic. An SOP that says "perform PCR according to manufacturer's instructions" is not GLP-compliant because it does not specify the exact conditions. Instead, the SOP should state: "Amplify the target sequence using 100 ng genomic DNA template, 0.5 µM each primer, 200 µM each dNTP, 1× Phusion HF buffer, and 0.5 U Phusion DNA polymerase in a 50 µL reaction. Thermal cycling conditions: 98°C for 30 s; 30 cycles of 98°C for 10 s, 60°C for 20 s, 72°C for 30 s; final extension at 72°C for 5 min." ## Common Pitfalls and How to Avoid Them ### Data Integrity Issues The most serious GLP violations involve data integrity. Common failure modes include: - **Backdating entries** — recording an observation days after it was made, without noting the delay. This is a critical finding that can invalidate an entire study. - **Undocumented corrections** — erasing or overwriting an incorrect entry instead of striking through and initialing. - **Uncontrolled electronic data** — storing instrument output on a shared drive where any user can modify or delete files. - **Transcription errors** — copying values from an instrument printout into a notebook or spreadsheet without preserving the original. **Prevention strategies**: implement a policy of "record at the time of observation, no exceptions." For electronic data, use validated systems with role-based access and mandatory audit trails. For manual data, use bound notebooks with numbered pages and a signature on each page. The [Good Laboratory Notebook Practices](/knowledge/molecular-biology/good-laboratory-notebook-practices) resource provides detailed guidance on maintaining compliant records. ### Inadequate SOPs SOPs that are vague, outdated, or not followed are a frequent audit finding. Specific pitfalls include: - **SOPs that do not match actual practice** — if your laboratory has changed a reagent concentration or a temperature setting, the SOP must be updated immediately. - **SOPs that are not available at the work site** — personnel cannot be expected to follow a procedure they cannot access. - **SOPs that lack sufficient detail** — "use appropriate amount of enzyme" is not an instruction. **Prevention strategies**: conduct periodic SOP reviews that include a "walk-through" where a scientist performs the procedure using only the SOP as a guide. Any discrepancy between the SOP and actual practice must be resolved—either by correcting the practice or updating the SOP. ### Poorly Managed Archives Archives that are disorganized, inaccessible, or environmentally uncontrolled can compromise the integrity of study records. Common issues include: - **No indexing system** — raw data cannot be located when needed. - **Inadequate security** — unauthorized personnel can access or remove records. - **Environmental damage** — humidity or temperature excursions degrade paper records or electronic media. - **No retention schedule** — records are discarded too early or retained indefinitely without a defined policy. **Prevention strategies**: designate a qualified individual as the Archivist, implement a documented indexing system, and establish environmental monitoring with alarms. For electronic archives, maintain regular backups and verify data readability on a defined schedule (e.g., annually). ### Lack of QA Oversight A Quality Assurance Unit that is understaffed, underfunded, or not truly independent cannot provide effective oversight. Common issues include: - **QA is combined with operational roles** — the same person who conducts the study also performs QA inspections, creating a conflict of interest. - **QA inspections are infrequent or superficial** — inspections are scheduled only when convenient, or are limited to checking signatures rather than verifying data integrity. - **QA findings are not acted upon** — management ignores QA recommendations, undermining the entire system. **Prevention strategies**: ensure QA reports to senior management, not to the operational department heads. Provide QA with adequate resources and authority to conduct thorough inspections. Establish a formal process for tracking QA findings to closure, with management review of the CAPA effectiveness. ## Frequently Asked Questions ### What is good laboratory practice (GLP)? Good Laboratory Practice (GLP) is a formal quality system that governs the organizational processes and conditions under which non-clinical safety studies are planned, performed, monitored, recorded, archived, and reported. It ensures that data generated in these studies are reliable, reproducible, and traceable, allowing regulatory authorities to make informed risk assessments. ### Why is GLP important in the pharmaceutical industry? GLP is important because regulatory agencies (FDA, EMA, OECD member countries) require GLP-compliant data for the approval of pharmaceuticals, pesticides, and industrial chemicals. Without GLP compliance, non-clinical safety data are not accepted, and the product cannot advance to clinical trials or market approval. GLP also protects public health by ensuring that safety decisions are based on trustworthy data. ### What are the main principles of GLP? The ten OECD GLP principles are: (1) organization and personnel, (2) quality assurance program, (3) facilities, (4) apparatus, materials, and reagents, (5) test systems, (6) test and reference items, (7) standard operating procedures, (8) performance of the study, (9) reporting of results, and (10) storage and retention of records and materials. ### How does GLP differ from GMP? GLP governs non-clinical safety studies (preclinical research), focusing on data integrity and study conduct. GMP governs manufacturing and quality control, focusing on product consistency and quality. GLP asks "Was the study conducted as reported?" while GMP asks "Was the product manufactured consistently to specification?" They apply at different stages of the product lifecycle. ### What are the common pitfalls in GLP compliance? Common pitfalls include data integrity issues (backdating, undocumented corrections, uncontrolled electronic data), inadequate SOPs (vague, outdated, or not followed), poorly managed archives (disorganized, insecure, or environmentally compromised), and lack of effective QA oversight (conflicts of interest, infrequent inspections, unaddressed findings). ### What is the role of quality assurance in GLP? The Quality Assurance Unit (QAU) is an independent group that monitors study compliance. Its roles include maintaining a master schedule of studies, conducting inspections at critical phases, reviewing final reports for accuracy, and reporting findings to management and the Study Director. The QAU does not conduct the science but verifies that the science is performed according to the study plan and SOPs. ### How do I implement GLP in my laboratory? Implementation begins with a gap analysis comparing current practices against GLP requirements. Prioritize actions that affect data integrity. Develop and implement SOPs for all routine procedures. Train all personnel on GLP principles and role-specific requirements. Establish a QAU function with independence from operational staff. Set up a secure archive with defined retention periods. Finally, conduct internal audits to verify compliance and address findings through a CAPA process. ## Key Takeaways - GLP is a quality system for non-clinical safety studies that ensures data integrity through defined organizational, procedural, and documentation standards. - The OECD, FDA, and EPA frameworks are the principal regulatory bases; OECD GLP offers mutual acceptance of data across member countries. - The ten core principles cover personnel, QA, facilities, equipment, SOPs, test systems, study conduct, reporting, and archiving. - Data integrity (ALCOA) is the foundation of GLP—every data point must be attributable, legible, contemporaneous, original, and accurate. - The Study Director is the single point of control for each study; the QAU provides independent oversight. - GLP differs from GMP and GCP in its focus on non-clinical data integrity rather than manufacturing quality or clinical patient safety. - Implementation requires a systematic gap analysis, comprehensive SOP development, staff training, and a functional QAU. - Common pitfalls—data integrity lapses, inadequate SOPs, poor archiving, and weak QA oversight—are preventable with disciplined processes and a culture of compliance. - A well-maintained GLP system not only satisfies regulators but also improves the scientific quality and reproducibility of your laboratory's work. ## Further Reading - Ito K, Someya H. *[Good Laboratory Practice: Initial Development, Necessity, and Issues of Data Reliability in Basic Research]*. Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan. 2019. [PubMed 31155529](https://doi.org/10.1248/yakushi.18-00193-1) - Wolf JC, Wolfe MJ. *Good laboratory practice considerations in the use of fish models*. Toxicologic pathology. 2003. [PubMed 12597432](https://doi.org/10.1080/01926230390178739) - Cho KH et al. *Basic Principles of the Validation for Good Laboratory Practice Institutes*. Toxicological research. 2009. [PubMed 32038812](https://doi.org/10.5487/TR.2009.25.1.001) - Fujikawa Y. *[Conducting Assured Nonclinical Studies in the Pharmaceutical Industry: Good Laboratory Practice (GLP) Study, GLP Inspection, and Standards for Assurance]*. Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan. 2019. [PubMed 31155530](https://doi.org/10.1248/yakushi.18-00193-2) - Begg S et al. *Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility*. Gates open research. 2020. [PubMed 32789289](https://doi.org/10.12688/gatesopenres.13133.1) - Jena GB, Chavan S. *Implementation of Good Laboratory Practices (GLP) in basic scientific research: Translating the concept beyond regulatory compliance*. Regulatory toxicology and pharmacology : RTP. 2017. [PubMed 28713068](https://doi.org/10.1016/j.yrtph.2017.07.010)
## Related Clinical & Scientific Guides * [MAPK Pathway: Mechanism, Function, and Clinical Relevance](/knowledge/molecular-biology/mapk-pathway) * [Mammalian Cell Culture Bioreactors: A Practical Guide](/knowledge/molecular-biology/mammalian-cell-culture-bioreactor) * [Nucleotide Formation: Biosynthesis and Assembly of DNA/RNA Building Blocks](/knowledge/molecular-biology/nucleotide-formation)