What Is Good Laboratory Practice (GLP)?
Good Laboratory Practice (GLP), as defined by the U.S. Food and Drug Administration (FDA), refers to a set of regulations and quality practices intended to ensure the reliability, consistency, and integrity of non-clinical laboratory studies. These studies are conducted to evaluate the safety, efficacy, and potential risks of products such as pharmaceuticals, biologics, medical devices.
There are a number of recognized standards, regulations, and guidelines governing GLP, the most predominant being the Organisation for Economic Co-operation and Development (OECD) Principles on Good Laboratory Practice and the US FDA’s 21 CFR Part 58 “Good Laboratory Practice for Nonclinical Laboratory Studies”.
What Is Covered In OECD GLP?
The OECD Principles of GLP concern “non-clinical” testing of a chemical or chemical product, examined under laboratory conditions or in the environment, including work conducted in greenhouses and in the field. They do not include studies which use human subjects.
Examples of studies carried out under GLP include:
- physical-chemical testing;
- toxicity studies;
- mutagenicity studies;
- the environmental toxicity studies on aquatic and terrestrial organisms;
- studies on behaviour in water, soil and air; bioaccumulation;
- studies to determine pesticide residues in food or animal feedstuffs;
- studies on effects on mesocosms and natural ecosystems; and
- analytical and clinical chemistry testing.
The OECD Principles on GLP includes ten (10) sections:
- Test Facility Organisation and Personnel
- Quality Assurance Programme
- Facilities
- Apparatus, Material, and Regents
- Test Systems
- Test and Reference Items
- Standard Operating Procedures
- Performance of the Study
- Reporting of Study Results
- Storage and Retention of Records and Materials
What Is Covered In 21 CFR Part 58?
The US FDA’s 21 CFR Part 58 prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. 21 CFR Part 58 contains nine (9) subparts (A through K):
- Subpart A – General Provisions
- Subpart B – Organization and Personnel
- Subpart C – Facilities
- Subpart D – Equipment
- Subpart E – Testing Facilities Operation
- Subpart F – Test and Control Articles
- Subpart G – Protocol for and Conduct of a Nonclinical Laboratory Study
- Subpart J – Records and Reports
- Subpart K – Disqualification of Testing Facilities
Who Must Comply with GLP?
Good Laboratory Practice (GLP) compliance is required any nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA, EU MHRA, etc.
Request a Quote
What Type Of Auditing Can GLP Require?
There are a number of different types of audits that can occur to ensure:
- Study audits: Review protocols, standard operating procedures (SOPs), and data, and inspect studies in progress.
- Vendor audits: Inspect facilities and equipment, review organization structure, and assess the qualification and training of personnel.
- Facility audits: Ensure compliance with GLP standards.
- Archive audits: Provide an unbiased perspective on the state of quality systems and compliance with regulations.
- Continuous improvement audits: Identify non-compliance and provide opportunities for improvement.
Quality Auditing provided ARAMARK with excellent service, highly qualified auditors and an exceptional and comprehensive audit report.
Jennifer J. QA Manager