Guide to Good Laboratory Practice

Science must be able to guarantee the reliability of its results. 

To this end, it is essential to define good laboratory practice that can be verified by third-party observers and attest to the validity of the tests.

Far from being a series of informal recommendations, Good Laboratory Practice (abbreviated BPL in Italian and GLP internationally, from Good Laboratory Practices) has merged into a series of internationally that indicate all the factors that a certified laboratory must take into consideration.

In the following article, we will look at the history of Good Laboratory Practice and provide a general overview of its principles.

History of Good Laboratory Practice

The need to establish criteria for the reproducibility of experiments, and therefore the reliability of results, has accompanied scientists since the beginning of the modern scientific revolution. So-called "laboratory conditions" have always been central to the concept of an experiment, as a practice that takes place in a controlled environment, isolated from external factors and human error.

And yet, it was only in the 1970s documents were drawn up that prescribed which factors laboratories and operators had to respect in order to guarantee the reliability of the results.

Denmark and New Zealand were the first countries to introduce a shared national document on Good Laboratory Practice, in 1972. 

In 1976, the US Congress proposed a similar draft which was approved in the following years and finally signed by all OECD countries in 1981.

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The 10 Points of Good Laboratory Practice

The OECD Guidelines for Good Laboratory Practice can be found here.

The document is divided into ten points that identify the various issues to be taken into account and are as follows.

• Organization and Staff.

Each facility must have a clear organizational chart regarding who is responsible for the laboratory and for verifying the application of these principles.

• Quality Assurance Program

The facility must have a clear quality assurance program that must be conducted and enforced by individuals not involved in the testing.

• Structures

This point outlines the minimum requirements that facilities hosting laboratories must have.

• Equipment, Materials and Reagents.

This point outlines the minimum safety requirements for equipment, materials and reagents.

• Test Systems

The test system is divided into physical/chemical and biological tests. Each test system must follow guidelines to ensure the isolation and reliability of the tests performed.

• Reference Substances and Test Tools

This section contains instructions on the proper storage of samples, substances, and other equipment involved in the experiment.

• Standard Operating Procedure

One of the most important points in which the drafting of a Standard Operating Procedure is imposed is the following one, described in its phases which articulate the points previously mentioned.

• Studio Performance

It emphasizes the need to draw up a study plan before conducting the study itself in order to have evaluation parameters independent of the results.

• Study Results Report

Indicates how to write the final report on the study conducted.

• Conservation and Classification of Materials and Reports

This point indicates which results and materials relating to the study must be stored in suitable facilities for the period of time indicated by the competent authorities.

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Reference Standards

• OECD Principles of Good Laboratory Practice (ENV/MC/CHEM(98)17, rev. 1997) — International GLP principles for non-clinical health and environmental safety studies.
• 21 CFR Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies. U.S. FDA Implementation of GLP Principles.
• Legislative Decree 50/2007 — Italian implementation of Directives 2004/9/EC and 2004/10/EC on GLP.
• ISO/IEC 17025 — General requirements for testing and calibration laboratories (complementary to GLP).
• EMA/CHMP/CVMP/JEG-3R(R)/450091/2012 — Guideline on the principles of regulatory acceptance of 3Rs testing approaches (alternatives to animal testing).
• 21 CFR Part 11 — Electronic Records and Electronic Signatures, applicable to GLP computerized systems.
• OECD Series on Principles of GLP (Monographs Nos. 1-17) — Application guidelines on archiving, computerized systems, and multi-site studies.

Authoritative Sources

• OECD – Organisation for Economic Co-operation and Development. International body that authored the globally recognized GLP principles.
• FDA – Food and Drug Administration. US regulatory authority, oversees 21 CFR Part 58 and GLP inspections.
• Istituto Superiore di Sanità. Italian GLP monitoring authority pursuant to Legislative Decree 50/2007.
• EMA – European Medicines Agency. The European Medicines Agency develops regulatory guidelines that complement GLP.

Frequently Asked Questions on Good Laboratory Practice (GLP)

What is the difference between GLP, GMP and ISO 17025?

The three systems have complementary but distinct purposes. GLP (OECD, 21 CFR Part 58) applies to non-clinical safety studies (toxicology, ecotoxicology, pharmacokinetics, pesticide residues) submitted to regulatory authorities as evidence of human/environmental safety. It focuses on data integrity, traceability of individual studies, and a responsible Study Director. GMP (EU GMP, 21 CFR 210-211) regulates the production of pharmaceuticals and APIs to ensure the quality, purity, and potency of the marketed batch. ISO/IEC 17025 is a technical standard for testing and calibration laboratories (environmental, construction, food analysis) that guarantees technical competence and the validity of analytical results. A GLP laboratory is often also ISO 17025 accredited, but the two are not the same: GLP is study-centric, ISO 17025 is laboratory-centric.

What are the 10 key components of GLP?

The 10 chapters of the OECD principles are: (1) Test Facility Organization and Personnel: Study Director, Principal Investigator, Management; (2) Quality Assurance Programme with independent inspections; (3) Facilities adequate to separate incompatible activities; (4) Apparatus, Materials, Reagents with documented calibration/maintenance; (5) Test Systems (animals, cells, plants, physical-chemical systems) with certification of origin; (6) Test and Reference Items with documented chemical characterization; (7) Standard Operating Procedures (SOP); (8) Performance of the Study with approved protocol and raw data; (9) Reporting of Study Results with final report signed by SD; (10) Storage and Retention of Records for a minimum of 10-15 years. The Italian ISS inspections periodically verify compliance with biennial cycles and QA audits.

How do you manage raw data and GLP computerized systems?

Raw data are the original records (paper or electronic) generated during the study and must comply with ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available. Electronic documentation follows 21 CFR Part 11 and OECD GLP Monograph No. 17 (Application of GLP Principles to Computerized Systems) requiring: audit trail (who/what/when/why), access control with user-specific login, redundant backups (3-2-1 rule), IQ/OQ/PQ validation of CDS software (Empower, OpenLab, LabSolutions), periodic review and change control. Electronic signatures require at least two factors and are legally equivalent to a handwritten signature. Retention is a minimum of 10 years from study completion, extended to 15 years for chronic OECD studies.

What environmental parameters must a GLP laboratory monitor?

Environmental monitoring for GLP depends on the sensitivity of the test systems. For animal facilities (toxicology tests): temperature 20-24 °C ± 2, humidity 45-65% RH ± 10, air exchange 10-15/h, light cycle 12h/12h ± 30 min, differential pressure between zones. For analytical laboratories (HPLC/GC-MS): temperature 20-25 °C ± 2, RH 30-70%, absence of vibrations and EM fields. For pharmaceutical stability chambers (ICH Q1A): setpoint 25 °C/60% RH (Zone II), 30 °C/65% RH (Zone IV), 40 °C/75% RH (accelerated), with uniformity ± 2 °C and ± 5% RH according to WHO TRS 953 Annex 2. All environmental data must be continuously recorded with ACCREDIA calibrated probes (PT100 uncertainty ≤ 0.15 °C, RH ≤ 1.5%) and archived as raw data to support the study. Multi-threshold alarms with SMS/email escalation are standard.