good laboratory practices.pptx

Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.

1. GoOD LABORATORY PRACTICES presented by : PREETI GUPTA

2. GLP: GOOD LABORATORY PRACTICES GLP is a FDA regulations. GLP was first introduced in New Zealand & Danmark in 1972 & Later in US in 1978. It regulates the process and condition under which clinical & non-clinical research is conducted. GLP also govers how these research facilities should be maintain. GLP embodies a set of principle that provides a frame work within which laboratory studies are planned, performed, monitored and archived report.

3. why GLP was created? In the early 70’s FDA becomes awares of case of poor laboratory practice all over the US. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were : Equipments not be calibrates to standard form therefore giving wrong measurements. Incorrect/ inaccurate account of the actual lab study. Inadequate test system.

4. Purpose of GLP To promote the quality of test date. To avoid duplicate of research. To improve the protection of human health and environment. To facilate international acceptance of test data. To prevent the creation of technical trade barriers.

5. Who & oecd members WHO has published standard for: Good Manufacturing practices (GMP) covering the manufacturing of drug products. Good Clinical Practice (GCP) covering clinical trials in human to establish efficacy and safety. OECD(Organization of Economic Cooperation and Development) members manage quality standard for: Non-clinical testing for the safety of potential products.

6. Scope of GLP GLP is requirements in regulatory non-clinical safety testing of the following test items: Pharmaceuticals products . Cosmetic products. Veterinary products. Food additives. Feed additives. Industrial chemicals.

7. Elements of GLP Test facilities management and personnel. Quality assurance programme. Facilities. Apparatuses, materials and reagents Test & reference items. Test system. Standard operating procedures. Performance of study results. Reporting of study results. storage and retention of records & materials.

8. Test facilities management and personnel Test Facility Management’s Responsibilities : Each test facility management should ensure that these Principles of Good Laboratory Practice are complied with, in its test facility. Study Director’s Responsibilities : The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report. Principal Investigator’s Responsibilities : The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice.

9. Quality assurance programme The test facility should have a documented Quality Assurance Programme to assure that studies performed are in compliance with these Principles of Good Laboratory Practice. The Quality Assurance Programme 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. This individual(s) should not be involved in the conduct of the study being assured.

10. Standard operating procedures Standard Operating Procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples. Test and Reference Items: Receipt, identification, labelling, handling, sampling and storage. Apparatus, Materials and Reagents: Apparatuses Use, maintenance, cleaning and calibration. Computerised systems Validation, operation, maintenance, security, change control and back-up. Materials, Reagents and Solutions. Preparation and labelling. Record Keeping, Reporting, Storage, and Retrieval. Test System (where appropriate). Quality Assurance Procedures.

11. Advantage and disadvantages of GLP Advantage of GLP: Increase confidence in the reliability and trustworthiness of laboratory data. Increase production of right first time results. Increase overall productivity. Increase laboratory reputation. Reduce need for re-work. Reduce time spent in non-revenue earning investigation. Disadvantages of GLP: More man power is required. Expensive process. Time consuming process.

12. Conclusion GLP is an internationally accepted, stringent regulation followed in the process of determination of Safety and assessment of potential hazards in pharmaceuticals, veterinary drugs, pesticides and feed additives. It carries paramounts importance in proving the non-clinical safety of the product to the health regulatory authorities in countries where the product requires to be marketed.

13. Thank you