Good Laboratory Practice

What does Good Laboratory Practice mean?
Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.

What are the principles of good laboratory practice?
The Principles of Good Laboratory Practice (GLP) is a managerial quality control system covering the organizational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived).

Why are good laboratory practices important?
Good Laboratory Practice embodies different principles which are designed to ensure and promote consistency, quality, safety, reliability and integrity of chemicals during non-clinical and laboratory testing.

What is the difference between GLP and GMP?
The GLP regulations are intended to ensure the quality and integrity of “open-ended” research studies of product safety, while the GMP regulations are intended to ensure the quality and safety of individual batches of regulated medical products through manufacturing and testing in accordance with pre-defined processes.

What is Good Laboratory Practice?
Good Laboratory Practice is defined as “a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.” 

The purpose of the Principles of Good Laboratory Practice is to promote the development of quality test data and provide a tool to ensure a sound approach to the management of laboratory studies, including conduct, reporting and archiving. The Principles may be considered as a set of standards for ensuring the quality, reliability and integrity of studies, the reporting of verifiable conclusions and the traceability of data. 

The Principles require institutions to assign roles and responsibilities to staff in order to ensure good operational management of each study and to focus on those aspects of study execution (planning, monitoring, recording, reporting, archiving) that are of special importance for the reconstruction of the whole study. Since all these aspects are of equal importance for compliance with GLP Principles.

It is not permissible to partially implement GLP requirements and still claim GLP compliance. No test facility may rightfully claim GLP compliance if it has not implemented, and does not comply with, the full array of the GLP rules.

As far as pharmaceutical development is concerned, the GLP Principles, in their regulatory sense, apply only to studies that:
  • are non-clinical, i.e. mostly studies on animals or in vitro, including the analytical aspects of such studies;
  • are designed to obtain data on the properties and/or the safety of items with respect to human health and/or the environment;
  • are intended to be submitted to a national registration authority with the purpose of registering or licensing the tested substance or any product derived from it.

Depending on national legal situations, the GLP requirements for non-clinical laboratory studies conducted to evaluate drug safety cover the following classes of studies :
  • Single dose toxicity
  • Repeated dose toxicity (sub-acute and chronic)
  • Reproductive toxicity (fertility, embryo-fetal toxicity and teratogenicity, peri-/postnatal toxicity)
  • Mutagenic potential
  • Carcinogenic potential
  • Toxicokinetics (pharmacokinetic studies which provide systemic exposure data for the above studies)
  • Pharmacodynamic studies designed to test the potential for adverse effects (Safety pharmacology)
  • Local tolerance studies, including phototoxicity, irritation and sensitization studies, or testing for suspected addictive and/or withdrawal effects of drugs.

GLP Principles are independent of the site where studies are performed. They apply to studies planned and conducted in a manufacturer’s laboratory, at a contract or subcontract facility, or in a university or public sector laboratory.

GLP is not directly concerned with the scientific design of studies. The scientific design 
may be based on test guidelines and its scientific value is judged by the (Drug) Regulatory Authority that provides marketing authorization. However, adherence to GLP will remove many sources of error and uncertainty, adding to the overall credibility of the study.

Through the application of technically valid and approved Standard Operating Procedures many sources of systematic error and artifacts may be avoided. The requirement to formulate a study plan with a defined scientific purpose for the study will prevent false starts and diminish the incidence of incomplete or inconclusive studies. Respecting the GLP Principles will thus indirectly optimize the scientific yield of studies.

When implementing GLP in a test facility, and particularly during training, it is important to clearly differentiate between the formal, regulatory use of the term Good Laboratory Practice and the general application of “good practices” in scientific investigations.

Since the term “Good Laboratory Practice” is not a trade-mark-protected term, any laboratory may consider that it is following good practices in its daily work. 
This does not comprise GLP compliance.

It must be clearly understood that only adherence to, and compliance with, all the requirements of GLP Principles constitutes real compliance with GLP. Therefore, the use of similar terminology to describe quality practices outside the scope of GLP proper should be strongly discouraged.

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