glp 112070804004

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  • 1. Prepared ByGuided By Ashvin RakholiyaMr. Pravin Mesariya M.Pharm Sem-1Quality Assurance

2. Contents Definition History General Provisions Organization and personnel Facilities Equipment Testing facilities operation Test and Control Articles Protocol for and Conduct of Nonclinical Study Records and Reports 3. Good Laboratory Practice Good Laboratory Practice is a quality systemconcerned with the organizational process andthe conditions under which a study is planned,performed, monitored, recorded, archived andreported.Why GLP? Development of quality test data Mutual acceptance of data Avoid duplication of data Avoid technical barriers to trade Protection of human health and theenvironment 4. HISTORY Created GLP is a formal regulation that was by the FDA(United states food and drug administration) in 1978. Although GLP originated in the United States , it had aworldwide impact. Non-US companies that wanted to do business with theUnited States or register their pharmacies in the UnitedStates had to comply with the United States GLPregulations. 5. They eventually started making GLP regulations intheir home countries. In 1981 an organization named OECD (organization foreconomic principles that are international standard.co-operation and development) produced GLP 6. Subpart A - General ProvisionsScope This part prescribes good laboratory practicesfor conducting non-clinical laboratory studiesthat support or are intended to supportapplications for research or marketing permitsfor products regulated by the FDA, includingfood and colour additives, animal foodadditives, human and animal drugs, medicaldevices for human use, biological products, andelectronic products. 7. Inspection of a testing facility A testing facility shall permit an authorisedemployee of the FDA, at reasonable times andin a reasonable manner, to inspect the facilityall records and specimens required to bemaintained regarding studies within thescope of this part.. If the testing facility refuses to permitinspection the Food and Drug administrtionwill not consider a non-clinical laboratorystudy in support of an application for aresearch or marketing permit. 8. Subpart B - Organisation and PersonnelPersonnel Each individual engaged in the conduct of orresponsible for the supervision of a non-clinicallaboratory study shall haveeducation, training, and experience There shall be a sufficient number of personnelfor the timely and proper conduct of the studyaccording to the protocol. Personnel shall take necessary personalsanitation and health precautions designed toavoid contamination of test and control articlesand test systems. 9. Personnel engaged in a non-clinical laboratory studyshall wear clothing appropriate for the duties theyperform. Any individual found at any time to have an illnessthat may adversely affect the quality and integrity ofthe non-clinical laboratory study shall be excludedfrom direct contact with test systems, test andcontrol articlesTesting facility managementFor each non-clinical laboratory study, testing facilitymanagement shall: Replace the study director promptly if it becomesnecessary to do so during the conduct of a study. 10. Assure that test and control articles ormixtures have been appropriately tested foridentity, strength, purity, stability, anduniformity, as applicable. Assure thatpersonnel, resources, facilities, equipment, materials and methodologies are available asscheduled. As sure that any deviations from theseregulations reported by the quality assuranceunit are communicated to the study directorand corrective actions are taken anddocumented. 11. Study director For each non-clinical laboratory study, a scientist or otherprofessional of appropriate education, training, andexperience, or combination thereof, shall be identified asthe study director. The study director has overall responsibility for thetechnical conduct of the study, as well as for theinterpretation, analysis, documentation and reporting ofthe results, and represents the single point of studycontrol. The study director shall assure that: The protocol including any change, is approved and isfollowed. All experimental data, including observations ofunanticipated response of the test system are accuratelyrecorded and verified. All applicable good laboratory practice regulations arefollowed. 12. Quality assurance unitResponsibilities Of The quality assurance unit Monitoring each study to assure managementthat thefacilities, equipment, personnel, methods, practice, records, and controls are inconformance with the regulations in this part. For any given study, the quality assuranceunit shall be entirely separate from andindependent of the personnel engaged in thedirection and conduct of that study. 13. Funtions of the quality assurance unit: Maintain a copy of a master schedule sheet Inspect each non-clinical laboratory study atintervals adequate to assure the integrity of thestudy and maintain written and properly signedrecords of each periodic inspection Determine that no deviations from approvedprotocols or standing operating procedures weremade without proper authorisation anddocumentation. A designated representative of the FDA shall haveaccess to the written procedures established forthe inspection and may request testing facilitymanagement to certify that inspections are beingimplemented, performed, documented, andfollowed-up in accordance with this paragraph. 14. Subpart C Facilities General Each testing facility shall be of suitable sizeand construction to facilitate the properconduct of non-clinical laboratory studies. Itshall be designed so that there is a degree ofseparation that will prevent any furtherfunction or activity from having an adverseeffect on the study. Animal care facilities A testing facility shall have sufficient numberof animal rooms or areas 15. Separate areas shall be provided, asproposed, for the diagnosis, treatment, andcontrol of laboratory animal disease. When animals are housed, facilities shall existfor the collection and disposal of all animalwaste and refuse or for safe sanitary storageof waste before removal from the testingfacility. 16. Facilities for handling test and control articles As necessary to prevent contamination ormix-ups, there shall be separate areas forReceipt and storage of the test and controlarticles, Mixing of the test and control articleswith a carrier, Storage of the test and controlarticle mixtures. Storage areas for the test and or controlarticle and test and control mixtures shall beseparate from areas housing the test systemsand shall be adequate to preserve theidentity, strength, purity, and stability of thearticles and mixtures. 17. Laboratory operation areas Separate laboratory space shall be provided,as needed, for performance of the routineand specialised procedures required by non-clinical laboratory studies.Specimen and data storage facilities Space shall be provided for archives, limitedaccess by authorised personnel only, for thestorage and retrieval of all raw data andspecimens from completed studies. 18. Subpart D EquipmentEquipment design Equipment used in the generation, measurement, orassessment of data and equipment used for facilityenvironmental control shall be of appropriate design andadequate capacity to function according to the protocoland shall be suitability located for operation, inspection,cleaning and maintenance.Maintenance and calibration of equipment Equipment shall be adequately inspected, cleaned, andmaintained. Equipment used for the generation,measurement, or assessment of data shall be adequatelytested, calibrated or standardised Written records shall be maintained of all inspection,maintenance, testing, calibration and standardisingoperations. 19. Subpart E - Testing Facilities OperationStandard operating procedures.Standard operating procedures shall beestablished for Animal room preparation. Animal care. Receipt, identification, storage, handling,mixing, and method of sampling of the testand control articles. Test system observations. Laboratory tests. 20. Handling of animals found moribund or deadduring study. Necropsy of animals or post mortemexamination of animals. Collection and identification of specimens. Histopathology. Data handling, storage, and retrieval. Maintenance and calibration of equipment. Transfer, proper placement, and identificationof animals. 21. Reagents and solutions All reagents and solutions in the laboratory areasshall be labelled to indicate identity, titre orconcentration, storage requirements, andexpiration date. Deteriorated or outdatedreagents and solutions shall not be used. Animal care There shall be standard operating procedures forthe housing, feeding, handling, and care ofanimals. All newly received animals from outside sourcesshall be isolated and their health status shall beevaluated At the initiation of a non-clinical laboratorystudy, animals shall be free of any. 22. If, during the course of the study, the animalscontract such a disease or condition, thediseased animals shall be isolated, if necessary These animals may be treated for disease orsigns of disease provided that such treatmentdoes not interfere with the study.The diagnosis, authorisation oftreatment, description of treatment, and eachdate of treatment shall be documented and shallbe retained. Animals of different species shall be housed inseparate rooms when necessary.. 23. Animal cages, racks and accessory equipmentshall be cleaned and sanitised at appropriateintervals. Feed and water used for the animals shall beanalysed periodically to ensure that contaminantsknown to be capable of interfering with studyand reasonably expected to be present in suchfeed or water are not present in levels abovethose specified in the protocol. Documentation ofsuch analyses shall be maintained as raw data. If any pest control materials are used, the useshall be documented