GOOD LAB PRACTICE (GLP) – BY OECD
Dr. Garima Chahar, Dr. Garima Kalra
MVSc Scholar
Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India
Email: garimachahar2010@gmail.com, vetgarimakalra@gmail.com
INTRODUCTION:
OCED (Organisation for economic co-operation and development) is an intergovernmental organisation with 38 member countries, founded in 1961 to stimulate economic progress and world trade.
Government and industry are concerned about the quality of non- clinical health and environment safety studies upon which hazard assessments are based. As a consequence, OECD member countries have established criteria for performance of these studies.
GLP is a quality system concerned with organisational process and the conditions under which non- clinical health and environment safety studies are planned, performed, monitored, recorded, archived, and reported.
One of the fundamental purposes of the principles of GLP is to ensure the quality and integrity of test data related to non- clinical safety studies.
SCOPE:
These Principles of Good Laboratory Practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals.
TYPES OF TESTS CARRIED OUT AT SUCH FACILITIES UNDER GLP:
- 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 animals feedstuffs
- Studies on effects on mesocosms and natural ecosystems
- Analytical and clinical chemistry testing
TYPES OF CHEMICALS / CHEMICAL PRODUCTS ARE COVERED BY THE OECD PRINCIPLES OF GLP:
- Pharmaceutical products
- Pesticide products
- Cosmetic product
- Veterinary drugs
- Food additives
- Feed additives
- Industrial chemicals
GOOD LABORATORY PRACTICE PRINCIPLES:
- Test Facility Organisation and Personnel – Each test facility management should ensure that these Principles of Good Laboratory Practice are complied with, in its test facility. It should be of appropriate size and location to fulfil the requirements of the study.
- Quality Assurance Programme – The test facility should have an appropriate Quality Assurance Programme to guarantee that studies performed comply with these Principles of Good Laboratory Practice. It should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.
- Facilities – Appropriate conditions should be established and maintained for the storage, housing, handling and care of biological test systems to ensure the quality of the data. Test facility should be of suitable size, construction and location in order to minimise disturbance that would interfere with the validity of the study.
- Apparatus, Material, and Reagents – Apparatus, including validated computerised systems, used for the generation, storage and retrieval of data, and for controlling environmental factors relevant to the study should be suitably located and of appropriate design and adequate capacity. Chemicals, reagents, and solutions should be labelled to indicate identity (with concentration if appropriate), expiry date and specific storage instructions.
- Test Systems –
Physical/Chemical- Apparatus used for the generation of physical/chemical data should be suitably located and of appropriate design and adequate capacity.
Biological- Proper conditions should be established and maintained for the storage, housing, handling and care of biological test systems, in order to ensure the quality of the data.
- Test and Reference Items – It includes receipt, handling, sampling and storage, characterisation. When adulterated with a carrier, adequate methods are applied to verify article concentration, mixture uniformity and stability of the articles.
- Standard Operating Procedures – A test facility should have written Standard Operating Procedures approved by test facility management that are intended to ensure the quality and integrity of the data generated by that test facility. It includes Test and Reference Items; Apparatus, Materials and Reagents; Record Keeping, Reporting, Storage, and Retrieval; Test System; Quality Assurance Procedures.
- Performance of the Study – It includes Study Plan; Content of the Study Plan; Conduct of the Study. All the standards supplied by the GLP should be applicable from the beginning of the study to the end by the final report.
- Reporting of Study Results – A final report should be prepared for each study and evaluated by the investigator considering the deviations occurred in the study.
- Storage and Retention of Records and Materials- Proper maintenance of records should be done accurately along with regular updates for example including appropriate labelling of specimens by test system, study, nature & collection date, records of gross findings from post-mortems available to pathologist for specimen histopathology.
CONCLUSION:
Good Lab Practise is a quality system of management controls for research organizations to ensure the quality, and integrity of products in development for human or animal health through non-clinical safety measures. Application of these principles should help to avoid the creation of technical barriers to trade and further improve the protection of human health and environment. These practices are essential for proper outcome of the results and safety of the technicians involved in the procedures. This will be the leading way to the evidence-based laboratory results with a more trustworthy approach.
