How to Maintain Good Laboratory Practice

How to Maintain penny-pinching Laboratory Practice cheeseparing science lab practiceIntroductionGood laboratory practice make up principles which give structure to the studies of which they are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate info by which the hazards and risks to users, consumers including the environment, can be assessed for pharmaceuticals, agro chemics, veterinary medicines, industrial chemicals, cosmetics, intellectual nourishment and feed additives and biocides.PurposeGood laboratory practice provides results from the study which are reliable and can be used for making risk/safety assessments.The Good laboratory practice regulations provide an interpretation of the terminology used in defining the elements of GLP. Here are few examplesStudy plan this is a register which shows why an experiment is being carried by and how it should be performed in order to comply with Good laboratory practice.Study Director- dealing with Good laboratory pliantStudy personnel- all the people that carry out the experimentsStudy initiation Date Date that the study fir treest signs the study planStudy architectural plan Amendment an intended change to study plan after the initial study dateStandard operating procedures sufficiently detailed work instructions to abandon the procedure to be repeated exactly the same way distributively time by any operator.FindingsRaw materialsRaw materials are reagents used in processing. They are classified regarding identification of samples for exampleEnzymes which are used in the study.Storage instructionsExpiry dateQuality e.g. purity of a chemicalSource of the material, preparation date and stabilityCell cultureEquipment maintenance and calibrationAll the equipment must be clean to function reliably.For each moment of equipment there should beA number for identification of the apparatus.A calibration check (should be traceable to national or internati onal standards)Validation that equipment fir for purposeStaff should be trained to use equipmentOperating and parametersClean equipmentData logging and trackingTransportDelivering chemicals by roads or by train learn the possibilities of accidents. If there is a leak it could cause a spillage which can cause cars to slide and hit each other which could potentially lead to an explosion which could cause fatalities as well as damage to the nearby surroundings.Customer servicesThe aim is to build up a trustfulness between clients and the company. Any reported problem from any client should be followed up and dealt with to the highest standard possible.Labelling, storage, packingAll the reagents must be fully designate withName of reagentWho made it?Date the item was preparedExpiry dateStorage conditionsHazard labelsName of the company or institutionIf the reagent is not tagged there is no evince of what it isStoring/Packing of dataMaterials required to be stored includeThe study pl an, raw data, samples of test and reference items, specimens and final report of each studyThe records of all inspection performed by the quality impudencePersonal recordsRecords and reports of the maintenance and calibration of equipmentValidation documentation for computerise systemsSOPsEnvironmental observe recordsThe materials retained should be properly indexed and movement of information should be noted.TrainingFor high quality GLP training, you need experienced Course Directors. Each Course Directors have to be from senior level scientific, regulatory and management positions in a variety of organisations and industries.ProceduresSOPs stands for Standard operating producersSOPs is a factor which in the production of products fit for their intended use. All the operators must be aware of all the relevant SOPs and implement them correctly.If there is a failure carrying them out correctly it means that it can lead to the production of products harmful, and potentially lethal t o customers.Implementing of quality standards for example what must happen in a work place to ensure compliance?Everyone in the lab should know what they are doing. In implementing Good Lab Practice the study director is the single point of govern for a given study and has the responsibility for its overall conduct and finial report.Standard Operating proceduresA key aspect of the study personnels design in ensuring good lab practice compliance in their work is the writing and implementation of standard operating procedures. These are work instruction, which are accurately detailed to allow the procedure to be repeated exactly the same way each time by any operatorInternal mentoringThose who have been in long term employment would be expected to encourage and support new and younger staff members. Giving guidance where it is needed.Quality assurance (QA)Quality assurance refers to all actions necessary to provide confidence that the product or service will satisfy the prescribed requirement for quality. QA involves the setting up of a quality system, and overseeing that this system is being implemented correctly.In short, quality assurance does exactly what it says. By considering all the aspects of the business process it ensures that the work being done will meet the required standard.The responsibilities of the Quality Assurancemaintain copies of all approved study plans and Standard Operating Procedures in use in the test facility and have access to an up-to-date copy of the master scheduleVerify that the study plan contains the information required for compliance with these Principles of Good Laboratory Practice.Recording of primary dataLog Book is a primary source of raw data in any process. It provides evidence which whitethorn be used in a court law it might also be sued in patent applications or used as a cross reference in auditing work.Monitoring temperatures in incubators or fridgesMonitoring temperature is very important in lab.For the operatio n of fridges and freezers we need to consider what temperature should it run at ?The required limit e.g. 4oC +/- -2oCAll fridges used for the storage of medicines must have the temperature monitored daily to ensure the correct storage of those medicines.Maintenance of log book funk note book should only be used.The hand writing should be clear so that operators can understand it.Blue or black sign must be used in order to prevent fading and allow documents to be photocopied easily.All pages should be numbered to prevent pages being removed.All data should be recorded.All data should be verified through the use of signatures and witnesses.Correction should be verified by being signed and dated.Blank lines or pages should be crossed out with a diagonal line signed and dated.All detailed information about instruments, samples, materials, and equipment should be included.The logbook should be stored in a secure location.Regulator Bodies which are involved in ensuring compliance with th e chosen standard are the governments and the trade association.Inspectors carry out biennial inspections of all labs indoors the UK that perform regulatory studies that require to be conducted to Good Lab PracticeAfter a satisfactory inspection by GLPMA, be issued with a contestation of GLP compliance.The GLPMA provides information to trade association and other Governments departments on aspects of GLP.RegulatorsGovernmentsThe Governments are responsible for enforcing the regulations in GLP on the behalf of the UK Monitoring AuthorityMHRA Medicines and Healthcare products RegulatoryVeterinary Medicines board of directors (DEFRA)Pesticides safety Directorate (DEFRA)Food standard agency for example feed addictives, novel and foods, food additives and food contaminants )Health and safety executiveEnvironment AgencyTrade associationsMonitoring complianceAssociation of British pharmaceutical industryAssociation of consultant bioscience industryCrop protection associationBritish Asso ciation of research quality AssuranceChemical aspects of Toxicology Discussion Group.Association of independent research testing organisationsUnited Kingdom accreditation service.