![Good Laboratory Practice (GLP) is a quality system that provides a framework for planning, performing, monitoring, recording, reporting, and archiving non-clinical health and environmental safety studies[1][3][8]. GLP ensures the quality, integrity, reliability, and reproducibility of safety test data submitted to regulatory authorities for research or marketing permits of regulated products[2][3][6][7]. These products include pharmaceuticals, color additives, food additives, medical devices, and other non-pharmaceutical agents[6].](https://cdn.drstemcellsthailand.com/wp-content/uploads/2025/02/image-46.png)
Good Laboratory Practice (GLP)
![Good Laboratory Practice (GLP) is a quality system that provides a framework for planning, performing, monitoring, recording, reporting, and archiving non-clinical health and environmental safety studies[1][3][8]. GLP ensures the quality, integrity, reliability, and reproducibility of safety test data submitted to regulatory authorities for research or marketing permits of regulated products[2][3][6][7]. These products include pharmaceuticals, color additives, food additives, medical devices, and other non-pharmaceutical agents[6].](https://pharmawiki.in/wp-content/uploads/2014/01/Good-laboratory-practice-glp.jpg)
Good Laboratory Practice (GLP): Ensuring Quality and Integrity in Non-Clinical Studies
Good Laboratory Practice (GLP) is a quality system that provides a framework for planning, performing, monitoring, recording, reporting, and archiving non-clinical health and environmental safety studies[1][3][8]. GLP ensures the quality, integrity, reliability, and reproducibility of safety test data submitted to regulatory authorities for Research and Clinical Trials or marketing permits of regulated products[2][3][6][7]. These products include pharmaceuticals, color additives, food additives, medical devices, and other non-pharmaceutical agents[6].
Key Principles of GLP
GLP principles outline requirements for various components[1]:
- Roles and Responsibilities: Defining the roles and responsibilities of individuals involved in GLP studies, including test facility management, study directors, principal investigators, study personnel, and quality assurance personnel[1].
- Quality Assurance (QA) Program: Establishing a QA program to monitor and ensure compliance with GLP standards[1].
- Facility: Maintaining a suitable facility, including proper archiving and waste disposal systems[1].
- Equipment and Materials: Ensuring that apparatus, materials, reagents, test systems, and test/reference items meet the required standards[1].
- Standard Operating Procedures (SOPs): Developing and following SOPs for all aspects of the study[1].
- Study Performance: Properly conducting the study and accurately reporting the results[1].
- Record Storage: Maintaining secure storage and retention of records and materials[1].
GMP vs. GLP
While both Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) are quality guidelines, they differ in scope. GMP applies to the entire manufacturing process of products, such as drugs, while GLP applies specifically to the safety testing phase[3].
GLP Compliance
Compliance with GLP is essential for research laboratories to ensure the quality and integrity of their data[3]. GLP is enforced by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States[3].
GLP in Medical Device Testing
The term GLP is also included in ISO 10993-1, an important standard for the medical device industry that addresses the biological evaluation of medical devices. ISO 10993-1 specifies that any testing to support a biological evaluation should be part of the manufacturer’s quality management system and subject to the same requirements for validation and traceability as any quality control test[5].
DrStemCellsThailand‘s Anti-Aging and Regenerative Medicine Center of Thailand and GLP Compliance
At DrStemCellsThailand‘s Anti-Aging and Regenerative Medicine Center of Thailand, we recognize the importance of GLP in ensuring the quality and reliability of our research and development activities. We are committed to:
- Adhering to GLP principles in all non-clinical laboratory studies related to our Cellular Therapy and Stem Cells.
- Implementing robust quality assurance programs to monitor compliance with GLP standards.
- Partnering with laboratories that are GLP-certified or compliant with equivalent standards.
- Ensuring that our Research and Clinical Trial data is accurate, reliable, and reproducible, meeting the requirements of regulatory authorities.
By adhering to GLP principles, we enhance the credibility and reliability of our Research and Clinical Trials, ultimately benefiting our patients through safer and more effective Cellular Therapy and Stem Cells.
Take the first step toward recovery by contacting us today for a consultation on how our advanced Cellular Therapy and Stem Cells, developed in compliance with GLP standards, can transform your health journey.
Consult with Our Team of Experts Now!
References
- Good Laboratory Practice Everything You Need to Know – Test Labs. Test Labs. Link
- Good Laboratory Practices (GLP): 2024 Guide – Biobide. Biobide. Link
- A Guide to Good Laboratory Practice (GLP) | SafetyCulture. SafetyCulture. Link
- Good Laboratory Practice (GLP) – EFSA – European Union. EFSA. Link
- What are the 5 main Good Laboratory Practices (GLP)? – Scilife. Scilife. Link
- What is GLP (Good Laboratory Practice)? – Certara. Certara. Link
- Good Laboratory Practice (GLP): Definition and Compliance. Biosoftware. Link
- Good laboratory practice – Wikipedia. Wikipedia. Link
