GLP 2024 v1 PDF

Good Laboratory Practices and Laboratory Safety October 5, 2024  HOUSE RULES This is an interactive discussion. Feel free to raise your hand/unmute your mic anytime (if online) of the discussion for questions or clarifications. Listen intently. Post evaluation would be posted aft...

Good Laboratory Practices and Laboratory Safety October 5, 2024  HOUSE RULES This is an interactive discussion. Feel free to raise your hand/unmute your mic anytime (if online) of the discussion for questions or clarifications. Listen intently. Post evaluation would be posted after the second batch of the discussion. Today’s Discussion GOOD LABORATORY PRACTICES – CONCEPT AND FUNDAMENTAL POINTS GENERAL CONCEPTS BEHIND LABORATORY METHODS LABORATORY RULES AND SAFETY Today’s Discussion GOOD LABORATORY PRACTICES – CONCEPT AND FUNDAMENTAL POINTS GENERAL CONCEPTS BEHIND LABORATORY METHODS LABORATORY RULES AND SAFETY  Definition of Good Laboratory Practices GOOD Fundamental Points of LABORATORY Good Laboratory PRACTICES Practices What is Good Laboratory Practices (GLP)? A quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, reported, recorded, and archived. ❑ Resources ❑ Characterisation Fundamental ❑ Rules ❑ Results Points of GLP ❑ Quality Assurance Fundamental Points of GLP Resources ❑ Personnel ❑ Facility: Building and Equipment Resources Personnel Organisational Chart Stresses that the number of personnel available must be sufficient Responsibilities defined in Job Descriptions Must be trained and equipped with enough knowledge to handle job Resources Facility: Building Facilities should be spacious enough to avoid the following: oOvercrowding oCross contamination oConfusion Facilities should have adequate and stable utilities e.g. water, electricity, etc. Resources Facility: Equipment Equipment should be sufficient and adequate to perform tests Equipment must be inspected, cleaned, and maintained Equipment should be calibrated at regular intervals  EQUIPMENT USAGE LOGSHEET Equipment Name: NEAR INFRARED SPECTROMETER (NIR) ID Number QCNIR.1-2017 Model/Brand BRUKER TANGO Serial Number: 200594 Time Time Date Activities Performed Used by Remarks Started Finished Resources Facility: Equipment Equipment Verification Forms should be accomplished at the prescribed frequency. Resources Facility: Equipment Equipment should be externally calibrated based on prescribed frequency (at least annually). ❑ Resources ❑ Characterisation ❑ Rules Fundamental ❑ Results Points of GLP ❑ Quality Assurance Fundamental Points of GLP Characterisation Reagents and Materials - Identity - Safety Charecterisation Reagents and Materials All bought and prepared solutions should be labeled with the following: a. Identity b. Concentration c. Storage Requirements d. Expiration Date (6 mos for prepared solutions) e. GHS Pictogram f. Date Prepared (for prepared solutions) g. Analyst name/initial (for prepared solutions) Reagents GHS GHS – Globally Harmonized System for Classification and Labelling of Chemicals System of hazard identification for chemical hazards Charecterisation Reagents and Materials Reagent: KCl, 3M Date Prepared: Jan 26, 2022 Expiration Date: June 26, 2022 Prepared by: Jenna Store in a cool, dry, well ventilated area. Light sensitive. Charecterisation Reagents and Materials Charecterisation Reagents and Materials SDS (Safety Data Sheet) - Summary of chemical properties, health hazard, chemical handling, and first aid measures. - Analyst should be familiar with the hazards and the first aid measures of a particular reagent. - Should be readily available Charecterisation Reagents and Materials Analyst should be mindful of proper disposal of sample and reagents. ❑ Resources ❑ Characterisation Fundamental ❑ Rules ❑ Results Points of GLP ❑ Quality Assurance Fundamental Points of GLP Rules Adhering to policy manual, written procedures, and work instructions Policy Procedures Work Instructions Rules Policy – Laboratory Quality Manual Required for implementing a quality management system (Based from ISO 17025:2017) Aims primarily at documentation, customer satisfaction, meeting customer requirements, prevention of occurrence of nonconformities Rules Procedure A sequential way of doing things normally presented by a process flow chart and may consist of several/varying persons doing the activities General process Rules Work Instructions Detailed step-by-step activity of doing something, sometimes incorporated in the procedure ❑ Resources ❑ Characterisation Fundamental ❑ Rules ❑ Results Points of GLP ❑ Quality Assurance Fundamental Points of GLP Results Instrument Reading Raw Data Logbook data Final report on numbered forms e.g. Product Evaluation Report; with Reports signatories Disposal of records after prescribed Archiving retention time Fundamental Points of GLP Results Ensure traceability of data from raw records to final reports At final report, ensure acknowledgement of all signatories (analyst, immediate superior, person to receive report if applicable) Follow “DCC” procedure for archiving records ❑ Resources ❑ Characterisation Fundamental ❑ Rules ❑ Results Points of GLP ❑ Quality Assurance Fundamental Points of GLP Quality Assurance Statistical procedure for data evaluation ▪Statistical Process Control ▪Quality Control Chart Audits Quality Assurance Statistical Procedure for Data Evaluation Statistical Process Control (SPC) - an industry-standard methodology for measuring and controlling quality during the manufacturing process - uses moving range chart Quality Control Chart (QC Chart) - data from QC materials - uses average values Quality Assurance Audits To monitor conformance of the laboratory against customer standards and regulatory standards Checks conformance and traceability of documented information, cleanliness and orderliness of site (laboratory area), and knowledge of personnel Today’s Discussion GOOD LABORATORY PRACTICES – CONCEPT AND FUNDAMENTAL POINTS GENERAL CONCEPTS BEHIND LABORATORY METHODS LABORATORY RULES AND SAFETY  Fundamental concepts on GENERAL CONCEPTS Analytical Chemistry and BEHIND LABORATORY Laboratory Basics METHODS Fundamental Concepts on Analytical Chemistry Definition Analytical Chemistry is the science of obtaining, processing, and communicating information about the composition and structure of matter. Involves the use of classical methods and the use of scientific instruments Fundamental Concepts on Analytical Chemistry Analytical Methods Classical Instrumental Methods Methods Rely on chemical Depend on the reactions to perform measurement of a an analysis; wet physical property of chemistry the analyte Can be divided into Uses an apparatus to qualitative (color, odor, measure physical etc.) and quantitative quantities such as light (gravimetry, volumetry, absorption, etc.) analyses fluorescence, etc Fundamental Concepts on Analytical Chemistry Analytical Methods – Classical Quantitaive Gravimetry: Moisture via gravimetry (usage of moisture analyzer/drying oven analyte signal is a method) measurement of mass Total dissolved solids/total soluble or change in mass solids (drying oven method) Volumetry: Determination of %Salt via Mohr Measurement of the volume of a solution whose concentration Titration is known and applied to determine the concentration of Titratable acidity via NaOH the analyte Titration Analytical Methods – Classical Quantitative Volumetry Indicator: added to the analyte to produce an observable physical change Titrant: reagent of known concentration added to analyte solution Analytical Methods – Classical Quantitative Volumetry – Definition of Terms Equivalence Point: Amount of titrant added is enough to completely neutralize analyte solution Endpoint: Point in titration when a physical change occurs; associated with chemical equivalence. Analytical Methods – Classical Quantitative Volumetry – Acid-Base Neutralization reaction between an acid and a base to form salt and water. e.g. Determination of Titratable Acid of Brine Solution Analytical Methods – Classical Quantitative Volumetry – Precipitation Titration Involves the formation of a precipitate (solids) during titration. e.g. Mohr titration for %Salt  Fundamental Concepts on Analytical Chemistry Analytical Methods – Instrumental i. Oven – Use for determination of % Moisture using Oven dying 1 i. Moisture Analyzer- use for determination of % Moisture using Infrared 2 3 4 5 6 7 8 9  Fundamental Concepts on Analytical Chemistry Analytical Methods – Instrumental A. Furnace – For % Ash Determination 1 A. Velp Fat Extractor for % Crude Fat Determination 2 3 4 5 6 7 8 9 Fundamental Concepts on Analytical Chemistry Analytical Methods – Instrumental A. Ankom Crude Fiber Set up for % Crude Fiber Determination 1 A. Foss Distiller and Foss Digester for % Crude Protein Determination 2 3 4 5 6 7 8 9  Fundamental Concepts on Analytical Chemistry Analytical Methods – Instrumental A. Stat Fax Reader- Mycotoxin reader 1 A. Microscope 2 3 4 5 6 7 8 9  Fundamental Concepts on Analytical Chemistry Analytical Methods – Instrumental A. Balances 1 A. Centrifuge 2 3 4 5 6 7 8 9  Fundamental Concepts on Analytical Chemistry Analytical Methods – Instrumental A. Shaker 1 A. Grinder - to decrease the particle size and to homogenize the sample 2 3 Fundamental Concepts on Analytical Chemistry Analytical Methods – Instrumental 1 1.1.1. Laboratory Refrigerator 2 3 4 5 6 7 8 9 10 11 12 13 Fundamental Concepts on Analytical Chemistry Analytical Methods – Instrumental 1 2 1.1.1. NIR (Near Infra Red Spectroscopy) 3 4 5 6 7 8 9 10 Fundamental Concepts on Analytical Chemistry Laboratory Basics On Weighing: - Ensure usage of analytical balance for more precise measurement. Top loading balances can be used for large magnitude and not so sensitive methods/analysis - Always use weighing containers e.g. beaker - Be mindful of temperature stability and vibrations around the area. Fundamental Concepts on Analytical Chemistry Laboratory Basics On Handling and Transferring of Liquids - Accuracy hierarchy: graduated cyclinder < measuring pipette < volumetric pipette < pipettor - On using glasswares for measuring liquid, be mindful of the meniscus. Observe with the glassware on eye level. LABORATORY SAFETY GOOD LABORATORY PRACTICES Improper Storage of Waste  Storage of waste in a fume hood where reactions are being carried out.  Leaving a funnel in the waste bottle.  A funnel can too easily be moved to an adjacent (incompatible) waste bottle and result in a fire or explosion. When you are done with it, cap it! LABORATORY SAFETY ACCIDENTS CAN HAPPEN TO ANYONE, ANY TIME, ANY WHERE.  LABORATORY SAFETY 32 Even if it is a day-to-day routine, RISKS REMAIN THE SAME. Recognize hazards, have preventive measures, & make emergency procedures. LABORATORY SAFETY TYPES OF HAZARDS CHEMICAL BIOLOGICAL PHYSICAL LABORATORY SAFETY TOP 5 LAB HAZARDS Fire/Explosion Skin Absorption of Chemicals Thermal and Chemical Burns Inhalation of Chemicals Cuts to the Skin LABORATORY SAFETY WORKING AREA LABORATORY SAFETY WORKING AREA clean and organized laboratory litter-free and non-slippery floors grounded electrical connections adequate illumination available spill kit, first aid box, emergency eye wash, emergency showers, emergency exit LABORATORY SAFETY FUME HOOD protects you from being exposed to chemical fumes, gases, and vapors that are generated within the enclosure fume hood is NOT a storage area use fume hood for all procedures that might result in the release of hazardous vapors or dust have an appropriate trap and make sure the setup is confined conduct all vacuum operations inside the fume hood LABORATORY SAFETY SPILLAGE immediately confine the area take note of the details of the incident do not clean up spills unless trained to do so wear protective gear when cleaning up spills supplies for cleaning should be in the kit (e.g., inert absorbent, plastic scoop, plastic bag, chemical-resistant gloves, and goggles LABORATORY SAFETY FIRST AID keep your first aid kit in a central location so it is easily accessible try to keep the contents of the first aid kit at room temperature if your first aid kit contains medications, remember to check expiration dates and replace when necessary usage must be well-documented and monitored LABORATORY SAFETY SHOWER & EYE WASH monthly routine check-up to ensure that emergency shower and eye wash are working properly shower requirements: - at least 30L/min water flow - must not shut off automatically - at least drinking water quality wash fountain requirements: - always cleaned - use sterile water LABORATORY SAFETY PERSONNEL Safety Procedures Wear apron or laboratory gown during the entire period of the laboratory work. Whenever anyone is working with chemicals or apparatus in the laboratory, safety goggles are required. Safety Procedures Do not dare touch a hot burner. Never throw a lighted match to the sink. Flammable solutions thrown at the sink may ignite fire. Flammable reagents like toluene, methanol, ethanol and many other organic compounds should be stored in closed containers and away from open flames.  Safety Procedures Avoid direct contact with chemicals: If you spill something, clean it up immediately before it dries or gets on your papers or skin. Any chemical spill on a person should be washed off immediately using safety shower. Any chemicals contacting one’s eyes should be immediately and thoroughly rinsed out using the safety wash.  Safety Procedures Never pipet by mouth. Many chemicals used in the laboratory are toxic. Never taste a chemical unless specifically directed to do so. Inhale odors and chemicals with great caution. Waft vapors toward your nose. Use the hood in performing experiments involving production of poisonous and irritating gases. Wash your hands thoroughly before leaving the laboratory to remove any potential chemical residues. Acids must be handled properly. If acids splash on the skin, wash the skin immediately with water and sodium carbonate solution, and then rinse again with plenty of water.  In diluting or mixing acids, always pour the acid slowly into the water while stirring. Do not reverse the process. So much heat may be liberated in the solution that steam may form with explosive violence. Safety Procedures Alkalis may damage the skin. Wash the skin with plenty of water and then with 1% acetic acid solution and rinse with plenty of water. Safety Procedures When heating a solution in a test tube, the mouth of the test tube should be away from the body. Do not point the test tube toward anybody. Safety Procedures Do not hold hot objects. Always use test tube holder or crucible tongs in handling hot dishes or apparatus. Always use a wire gauze, asbestos pad, or water bath in heating a container. Do not touch glass that has been near a flame or hot plate. Hot glass looks the same as cool glass and may cause serious burns. 46 HANDLING CHEMICALS Laboratory Safety CHEMICAL HANDLING & STORAGE ❑ always review SDS for proper storage conditions and procedures ❑ do not leave chemicals in the working area ❑ use “first in, first out” system ❑ regularly inspect stored chemicals for expiration, deterioration, and integrity ❑ do not overcrowd shelves ❑ storage cabinets should not be above shoulder height ❑ label storage cabinets according to chemical family or hazard classification LABORATORY SAFETY LABORATORY SAFETY LABORATORY SAFETY SAFETY DATA SHEET product identification composition hazards identification - emergency overview - potential health effects -potential environmental effects first aid measures accidental release measures handling and storage physical and chemical properties stability and reactivity proper disposal LABORATORY SAFETY EMERGENCY RESPONSE LABORATORY SAFETY EMERGENCY RESPONSE Do not panic. Familiarize the exit points in the laboratory Turn off all electrical equipment Orderly leave the building and gather at assembly point designated by the company Thank You!!!