GOOD LABORATORY PRACTICE (GLP)

Why need GLP?

1. GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study. 2. GLP also makes sure that data is traceable. 3. GLP promotes international acceptance of tests.

Scope
Categories of test item: 1) industrial chemicals 2) feed additives 3) pesticides 4) biotechnology (non-pharmaceuticals) 5) others

Type of studies/area of expertise on test item: 1) physical-chemical testing 2) toxicity studies 3) mutagenicity studies 4) environmental toxicity studies on aquatic and terrestrial organisms 5) studies on behavior in water, soil and air; bioaccumulation 6) residue studies 7) studies on effects on mesocosms and natural ecosystems 8) analytical and clinical chemistry testing 9) others

Requirements
- Test Facility Management (Project Manager) - Study Director - Quality Assurance Unit (few people or one individual) - GLP manual - Recent organization charts - Floor plans with GLP marked area - Proper documentation of the entire SOPs including: a) Test and reference item b) Apparatus, material and reagent c) Report keeping, reporting, storage and retrieval d) Test system e) Quality assurance procedures - Proper calibration and maintenance of all the equipment and instruments - Proper labeling of all the samples, reagents, solvents and etc. - Proper storage of all the test items - Proper record of all the raw data - Labeling of all the samples, reagents, solvents and etc. - Proper filing of hand-written and computerized data labeling of all the samples, reagents, solvents and etc.

Importance of GLP
- To ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances. - To assure the quality and integrity of the data generated and allows the data to be used with confidence by relevant Regulatory Authorities and users.

OECD Countries
1) Australia 2) Austria 3) Belgium 4) Canada 5) Chile 6) Czech Republic 7) Denmark 8) Estonia 9) Finland 10) France 11) Germany 12) Greece 13) Hungary 14) Iceland 15) Ireland 16) Israel 17) Italy * Partial OECD Countries 1) Russia 2) Brazil 3) China 4) India 5) Indonesia 18) Japan 19) Korea 20) Luxembourg 21) Mexico 22) Netherlands 23) New Zealand 24) Norway 25) Poland 26) Portugal 27) Slovak Republic 28) Slovenia 29) Spain 30) Sweden 31) Switzerland 32) Turkey 33) United Kingdom 34) United States

Countries that require GLP

1) Thailand 2) Philippines 3) Sri Lanka 4) Morocco 5) Mexico 6) Malaysia