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Equipment reagent and materials in glp
- 1. Miss: Bageshri SunilMestry
- 2. 2 GLP Good Laboratory Practice(GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. (OECD, 1997) What is GLP?
- 3. 3 GLP Adamo JE etal. A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure. Acad Med. 2012 Mar;87(3):279–84.
- 4. 4 GLP • GLP isan FDA regulation which is accepted and approved as international standards by OECD to avoid the fraud activities of the testing laboratories for pesticides, pharmaceuticals, food additives, dyes to save the human and environmental health also erect good international trade and establish good relationship among the countries • GLP compliance is monitored in India by NGCMA since 2002. GLP
- 5. 5 GLP Scope of GLP(OECD) Principlesof GLPapply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing - Pharmaceuticals Pesticides Food and feed additives Cosmetic products Veterinary drug products and similarproducts Industrial chemicals
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- 7. 7 GLP GLPPrinciples 01 02 0304 08 07 06 05 Test Facility Organisation and Personnel Quality Assurance Programme Facilities Apparatus, Material & Reagents Reporting of Study Results Performance of the Study Test and Reference Items & SOP Test Systems 09 Storage and Retention of Records and Materials
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- 9. 9 GLP Apparatus • Apparatus, includingvalidated computerised systems should be of appropriate design & adequate capacity • The instruments, instrument bench and surrounding areas should be kept clean and tidy at all times • A progress register for non- functional equipment and action for procurement of spares and accessories, monitoring thereof, shall be maintained
- 10. 10 GLP Apparatus • Apparatus tobe periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures. • The analytical instrument shall be housed in a dust free environment and whenever required, conditions of temperature and humidity shall be maintained and periodic checks on temperature and humidity be made and recorded • The Laboratory shall be furnished with all types of equipment as may be necessary for carrying out the different activities within the laboratory
- 11. 11 GLP Apparatus Equipment records shallbe maintained and such records shall contain the following :- i.Name of equipment or machine or apparatus ii.Manufacture’s name, model number and type of identification iii.Serial number iv.Date on which equipment was received in laboratory v.Current location vi.Condition when received vii.Copy of manufacture’s operating instructions viii.Frequency of calibration ix.Frequency of maintenance x.Log book
- 12. 12 GLP Apparatus xi. Staff responsiblefor monitoring the calibration and maintenance status of the equipment xii. List of authorised user or operators, if any xiii. History of any damage, malfunction, modification or upgradation, repair and calibration xiv. List of spares and accessories, if any
- 13. 13 GLP Apparatus • A SOPfor preventive maintenance of machine or equipment or apparatus shall be prepared by the laboratory • Maintenance should be handled by the competent person • Autoclave must be maintained and meet the requirements • Working on harmful gas should be done in the fume cupboards
- 14. 14 GLP Maintenance, calibration andvalidation of equipment • All equipments, instruments and other devices used in laboratory shall use appropriate methods and procedures for all tests or calibrations and they shall be regularly calibrated and validated. The frequency of calibrations may differ from instrument • The original equipment manufacture’s recommendations along with the experience o the laboratory staff and the use of equipment per day may also be considered while fixing the frequency of calibration • For most of the equipments and instruments SOP for calibration and calibration schedule be prepared by the laboratory and a logbook shall also be prepared by each laboratory for proper documentation of calibration results
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- 16. 16 GLP Chemicals and Reagents •Chemicals, reagents and solutions should be labelled to indicate identity, Conc, DOE & storage instructions • Storage and handling shall be done in the manner considering the physicochemical properties • A standardisation register shall be maintained by the laboratory along with its raw data and SOP for preparation and standardisation on stock solution, standardisation solution, volumetric solutions must be prepared for the guidance of staff
- 17. 17 GLP Chemicals and Reagents •Containers of stock solutions and of standard solutions shall bear the following details i. Name of analytical chemist who prepared the solution ii. Date of preparation iii.Each volumetric solution shall have “use before date” depending upon the stability of the solution and iv.Standardisation records • Transfer of hazardous chemicals and reagents from one container to another should be carried out by using suitable equipment by taking care of safety
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- 19. 19 GLP Reference Material • Referencematerials are necessary for the testing and or calibration, validation or verification of the sample or of equipment, instruments or other devices and all these materials should be traceable to agency authorised by Government of India or any other national body • The laboratory shall prepare working standards by comparing with the reference standard and shall be routinely checked for their purity by selecting parameters such as identity, LOD, Moisture content, impurity and assay
- 20. 20 GLP Reference Material • Aregister pertaining to reference and work material should be maintained by the laboratory . The following details may be mentioned in the register i. Source of supply ii. Code number of the reference material iii.Date of receipt iv.Batch number or identification number of the supplying agency v. Details like assay value, water content or any other information provided vi.Storage condition of the material and vii.Date of expiry, if any and date of manufacturing if possible
- 21. 21 GLP Reference Material • Allworking standards shall be checked at appropriate intervals or before use to ensure that it has not deteriorated or decomposed during storage. These observations be recorded in a register. All the reference and the working standards shall be stored at appropriate storage conditions
- 22. 22 GLP Apparatus, Materials &Reagents Should not interfere adversely with the test systems.
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Editor's Notes
- #3 Not GLP – Excellence of a laboratory Quality of an organisation Quality of a product Professional competence PLANNED………..which is why great emphasis is placed on the study plan (protocol) and to planned changes throughout the study. PERFORMED…….this refers to the standard operat- ing procedures (SOPs) which are a GLP require- ment. RECORDED………i.e. the collection of raw data and the recording of deviations, if any, during the study. REPORTED……….one of the problems pre-GLP was that study reports did not always reflect the study data accurately. Assuring accuracy in the report has now become an essential part of GLP. ARCHIVED……….as studies may be audited many years after their completion, it is important that the study data, specimens, samples and reports are properly archived. MONITORED……..monitoring by study staff, quality assurance personnel and national inspectors helps to assure GLP compliance.
- #4 Not GLP – Excellence of a laboratory Quality of an organisation Quality of a product Professional competence PLANNED………..which is why great emphasis is placed on the study plan (protocol) and to planned changes throughout the study. PERFORMED…….this refers to the standard operat- ing procedures (SOPs) which are a GLP require- ment. RECORDED………i.e. the collection of raw data and the recording of deviations, if any, during the study. REPORTED……….one of the problems pre-GLP was that study reports did not always reflect the study data accurately. Assuring accuracy in the report has now become an essential part of GLP. ARCHIVED……….as studies may be audited many years after their completion, it is important that the study data, specimens, samples and reports are properly archived. MONITORED……..monitoring by study staff, quality assurance personnel and national inspectors helps to assure GLP compliance.
- #6 An experiment or set of experiments in which a test item is assessed under laboratory conditions or in the environment to obtain data on its properties and/or safety, intended for submission to appropriate regulatory authorities.