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TANVI .R.PARDHI

General privision organization and personnels

Chandrashekhar3
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TANVI .R.PARDHI

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  1. CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY, Deori MAHARASHTRA Subject – Pharmaceutical quality assurance topic- General privision organization and personnels Presented by – Tanvi r pardhi Class – B.Pharm 3rd year 6th sem GUIDED BY –BADWAIK SIR

  2. GOOD LABORATORY PRACTICES GLP are the guidelines for quality control and quality assurance in testing laboratories.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. New Zealand and Denmark are countries where Good laboratory practices was firstly introduced in 1972 It was followed few years later by the organization for Economic Co- operation and development [OECD] principle of GLP in 1992 ; the OECD has since helped promulgate GLP to many countries. GLP is a quality management system. GLP defines a set of quality standards for study conduct, data collection, and results reporting.

  3. GLP only applies to non-clinical studies and testing which are conducted for the assessment of the safety or efficacy of chemicals to man, animals and the environment The main purpose of GLP is to ensure and promote safety, consistency, high quality and reliability of chemicals in the process of non-clinical and laboratory testing. The GLP also useful for medical devices, food additives, food packaging, colour additives

  4. GENERAL PROVISION SCOPE: 1. 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. 2. These test items are mostly synthetic chemicals having natural or biological origin or living organisms. 3. The purpose of testing is to get data on their properties and their safety with respect to human health.

  5. OBJECTIVES OF GLP 1. GLP provides the data submitted are accurate from the results which are obtained during course of the study. 2. Data obtain is traceable 3. There is an international acceptable for tests 4. Prevent equipment errors in measurements 5. Adopt good and safe operating procedures and recording systems 6. Prevent human errors in performance of the job 7. Improve efficient performance of the job 8. Prevent unsafe And hazardous acts which could affect individuals and property.

  6. ORGANIZATION AND PERSONNEL Organization: Performance of numerous quality oriented tasks or quality control work elements is required to achieve quality in the product. Organizing of quality is the identification of the essential quality control work elements and assignments of responsibility for getting done. GLP require that testing facility management should designate a study director or each non clinical laboratory study.

  7. Top management To develop company quality plan for achieving the company goals. To develop company quality objectives To design organizational structure To design system of product quality evaluation, audits, surveillance Head of Quality department Evaluation of batch records Approval or rejection of starting material, packaging material, bulk and finished products Approval of quality control procedures, instructions, test methods Maintenance of manufacturing and testing environment Maintenance of record Maintenance of premises equipments and departments    

  8. Personnel The responsibilities of all personnel should be defined and recorded in job descriptions and their qualifications and competence defined in education and training records. To maintain adequate levels of competence, GLP attaches considerable importance to the qualifications of staff, and to both internal and external training given to personnel. The Study Director who controlling the whole study. This person is appointed by the test facility management and will assume full responsibility for the GLP compliance of all activities within the study.

  9. Study director should be a scientist or other professional of appropriate education, training and experience or combination. Training is important tool for doing a job effectively. There should be arrangement of training program for all personnel. Any person with an illness that could adversely affect the integrity and quality of the study must be excluded from it until full recovery.

  10. THANK YOU!

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