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Procedures and Good Laboratory Practices (GLPs). Dr. Attya Bhatti Lecture # 8. Good Laboratory Practices (GLP). GLP embodies a set of principles that provides a framework within which laboratory studies are planned performed, monitored, reported and archived.
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Procedures and Good Laboratory Practices (GLPs) Dr. Attya Bhatti Lecture # 8
Good Laboratory Practices (GLP) • GLP embodies a set of principles that provides a framework within which laboratory studies are planned performed, monitored, reported and archived. • Applies to non-clinical studies. • GLPs must not be confused with standards of laboratory safety like wearing lab coats etc.
WHY WAS GLP CREATED? 1. Poor laboratory practice. 2. Equipment not been calibrated to standard form ,therefore giving wrong measurements. 3. Incorrect/inaccurate accounts of the actual lab study. 4. Inadequate test systems
History of GLP • Formal Regulation of FDA. • 1972: First introduced in New Zealand and Denmark • 1978: Introduced in US in response to ‘Industrial Bio Test Labs’ scandal. • 1981: an organization named OECD (organization for economic co-operation and development) produced GLP principles that are international standard. • International Organization for Standardization (ISO).
Objectives of GLP • GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study. • GLP also makes sure that data is traceable. • Promotes international acceptance of tests.
Goal To certify that every step of the analysis is VALID
Mission of GLP • Test systems • Standard operating procedures (SOP) • Personnel and test facility organization • Archiving of records and materials • Apparatus, material and reagent facilities • Quality assurance programs • Performance of the study • Reporting of study results
Study Director For each study to be performed, the facility management must appoint a study director – the individual responsible for the overall conduct of the study.
Quality Assurance Unit Must be designated to audit the laboratory studies and the accompanying data. It may be a separate department or an individual person, either full- or part time, indeed any person other than the study director. QAU is also responsible for preparing a GLP inspection and for supplying the data to the FDA or other control agencies. The QAU is designated by the testing facility management.
Personnel Must be qualified through education, training and/or experience to follow directions and perform test procedures properly.
Standard Operating Procedures (SOPs) All laboratory activities must be performed in accordance with • correctly written and • properly filed, • management-approved standard operating procedures (SOPs). • These must be readily available to the personnel concerned. • They should cover policies, administration, technical operation, equipment operation and analytical methods
Cont’d… • Written procedures for a laboratories program. • They define how to carry out protocol-specified activities. • Most often written in a chronological listing of action steps. • They are written to explain how the procedures are suppose to work
Copies of SOPs for equipment should be located close to the instruments and must be easily accessible by operators.
Control and test articles Must be identified and characterized by strength, purity, and stability. Reagents and solutions must be labeled with information on origin, identity, concentration, storage conditions, and expiration date.
Equipment Instruments must be designed to meet analytical requirements and regularly maintained and calibrated and copies must be kept on these procedures.
How to conduct a GLP study • A protocol must be in place for each study. • The protocol should be written before the start of the study. • Scientifically justified changes can be made, if the changes are documented and authorized by the study director.
Enforcement of GLP • Enforcement of GLP – certification and audits of analytical laboratories – is the responsibility of government agencies. • These government agencies may perform detailed examinations of any laboratory facility within its authority at reasonable times and in a reasonable manner.
Frequency of Inspections • This varies from country to country. • In the US, the FDA has two different types of inspections: • The routine inspection constitutes a periodic determination of the facility’s compliance with the regulations. The toxicological facilities and animal handling areas may be inspected annually, but frequently the laboratory itself is not inspected. A data audit may be done. • Cause inspections are conducted less frequently. The assignment of this inspection is sometimes initiated by routine inspections when serious non-compliance with GLP regulations is found. Laboratories are not notified beforehand.
Work as a Team • When performing potentially hazardous/dangerous operations always: • Make sure someone is in the laboratory with you • Notify someone that you are in the lab and what time you will check with them when you complete your work. • Check-in with that person if you exceed your time estimate or if you leave.
A Cluttered Lab is a Dangerous Lab! Keep your lab clean!
Housekeeping The Results of Poor housekeeping: • Accidents • Messy counter tops are a good source of spills. • Poorly maintained equipment or apparatus can break spilling its contents, damage other equipment or flying debris can cause injury. • Containers and equipment on the floor can cause hazard.
Housekeeping The Results of Poor housekeeping: • Costs you money • Overstocking or reordering of chemicals due to uncontrolled or unmanaged inventory. • Replacing spilled chemicals or damaged equipment.
Housekeeping The Results of Poor housekeeping: • Contaminates your research • Poorly washed containers or equipment can lead to cross contamination. • Poorly labeled storage containers can lead to the use of a wrong reagent.
Housekeeping Poor housekeeping: • Causes accidents: • Costs you money • Contaminates your research • Sets up bad habits for students entering a more regulated industrial setting. • Gets more attention from inspectors.
Don’t Block Access to Electrical Panels, Safety Showers and Eye Wash Stations
Old Equipment Can Be Dangerous Maintain your Equipment! Rusty water-bath with exposed wires
Improper Chemical Storage • Ether was stored in domestic style refrigerator. Either the thermostat or the interior light was the ignition source that caused the explosion. • Flammables have to be stored in a Flammables or Explosion proof fridge.
Lack of Attention to Details Heater/stir plate being used to stir only accidentally was also turned on as hot plate also!
Incomplete reaction placed in refrigerator Reaction container was placed into the refrigerator before the reaction had been completely quenched. The bottle over pressurized and exploded.
Proper Equipment Usage • There needs to be a written Standard Operating Procedure for all equipment. • Everyone should be properly trained before using any equipment. • Improperly used or maintained equipment can be dangerous to your health or can result in expensive damages. • Fires are common result with inappropriate equipment usage.
Hazards • Mechanical failure of rotating parts (often violent). • Contact with rotating parts. • Sample leaks causing aerosols, stress corrosion, contamination. • Sample imbalance causing machine movement / walking (or stress failure of component parts). • Fire or explosion. • Health (contact with contaminated components / vapors).
Dancing Centrifuge This can be caused by an improperly balanced rotor.
Remember Good Practices • Never work alone. • Commit to good housekeeping • Do not block access to doors, electrical or emergency equipment • Store chemicals and wastes properly • Maintain equipment
