Importance of GLP:- GoodLaboratory Practice (GLP) ensures that there is a standard framework ofprocedures for the way in which steps such as planning, performing, monitoring,recording, reporting and archiving of laboratory studies are conducted. This isdone by having an SOP which stands for Standard Operating Procedure. The SOPensures that there is minimal person to person and test to test variabilitybecause as many factors as possible are being kept constant so that theindependent variables will be the main determinants of the results.
This inturn leads to more consistency in the quality of products that are made and theresults are more likely to be reliable such that the assessments and analysisof the data can thus be valid.. Furthermore, it will be easier to record anddocument the steps that are involved in the experiments and easier and moreeffective comparisons between experiments can be made. With simpler documentationformats and more standardised archiving, it also allows audit visits to becarried out more smoothly. The GLP also helps to ensure that the results thathave been obtained through the trials carried out comply with the requirementsthat have been state by the regulatory authorities hence preventing penalties fromgetting imposed on them. With GLP, information about the trial can also then betraceable, ensuring full transparency. GLP also promotes internationalacceptance of tests. This is because, following the same steps can lead to thesimilar results hence showing that the results are reproducible and not just aone-off occurrence.
In short, having GLP ensures that the final products madeare safe, efficacious and are of good quality, hence minimising the potentialfor adverse effects to occur had there not been such measures taken.How GLP can be achieved:GLP can be achieved by adhering to the following steps. 1. It isimportant to routinely test the systems to ensure that all equipment is workingthe way they should be working. 2. Weshould Archive all records and materials to be transparenta. Maintain our records for at leastfive yearsb.
All analytical reports should be signedand dated by the analytical project manager to show that he accepts theresponsibility of the data and assures the validity of the results. 3. All equipment,material and facilities should be in optimal condition. Otherwise,action should be taken.
a. Facilitiesshould be of proper size, put at appropriate locations and be of suitabledistance apart from other facilities so as to not cause any disturbance to eachother’s functions b. Equipmentshould be tested out before usage to ensure that there are no problems with itand the instruments should also be calibrated to prevent systematic errors.
c. Details of allsamples should be recorded4. Weshould have quality assurance programs. a. Purchasingand testing of materials should be standardised.
i. All materials (reagents and solutions) should be labelled. ii. The date of opening should be noted. iii.
They should be stored at room temperature and should not be used afterthey have expired.5. Thestudy plan and performance of the study should be monitored closely, and resultsat various stages of the study should be reported6. Personnelshould have proper training and competence in terms of education and/or experience tocarry out the specific procedures required in the experiment and there shouldbe sufficient number of staff7.
Thereshould be specific protocol for carrying out the activities in the experiment.This should be written in chronological order and should explain how eachprocedure is supposed to work.