GOOD LABORATORY PRACTICES

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A SHORT DESCRIPTION ABOUT GLP . BY AKSHAY NEMA

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Good Laboratory Practices (GLP):

Good Laboratory Practices (GLP) by: Akshaya nema b.Pharma

Contents::

Contents: What is meant by GLP? Importance of GLP. History and Regulation. Objective. Safety aspects and Laboratory hazard. Factor contribution to GLP. Application. Conclusion.

What is GLP:

What is GLP Good Laboratory Practice is an essential part of Good Manufacturing Practice detailed in Schedule M to the Drugs & Cosmetic Rule. It involves a number of good practices in the Quality Control laboratory which are to be undertaken to carry out an analysis with a defined degree of Accuracy & Precision

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SAMPLE Laboratory processes Results of Analyses Good Laboratory Practices GLP

Importance of GLP:

Importance of GLP Since raw materials, packaging materials, intermediates and finished products are ultimately released based on the analytical results generated in the Q.C. Laboratory, Accuracy, Precision and Reliability of these results are of paramount importance.

History and Regulation:

History and Regulation GLP term is first used officially in “New Zealand test laboratory act” where development and maintenance of GLP is testing had been made in task. FDA published proposed regulations for GLP in “Federal register” on Nov 19,1976. Register of Sep 4,1987,the FDA amended its GLP regulations with the intent of reducing the regulatory burden on testing facilities.

Objectives:

Objectives Jobs should be performed efficiently and always improve our mistakes. Always adopt good and safe operating procedures. Prevent human error in performance of job. Not to do any unsafe and hazardous acts which could affect your classmates or to you own.

Safety aspects and laboratory hazards:

Safety aspects and laboratory hazards Always wear safety shoes , laboratory coats, safety glasses .No eating ,no drinking. Be careful with power supply ,gas cylinder . Ensure that safety devices and precaution manuals are easy to find. Always careful with power supply. Do work in a serious manner.

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Avoid mouth pipetting. Use of vacupads or auto pipettes is advisable. Nearly all organic solvents are hazardous . Some are probably carcinogenic and should be treated with extra caution. Beware of physical hazards from electrical lines and gas cylinders. Always remember HOT glass wares looks exactly like COLD glass wares be careful while candling.

Factors contribution to GLP:

Factors contribution to GLP Premises. Equipment. Cleanliness. Sampling. Instrumentation and calibration. Specification. Facilities. Training.

Applications:

Applications GLP can be also applied in another way: It could serve to protect researcher from unfounded allegations. It can also be applied in recording data. It can also be applied in research environment. It can also be used to improve the coordination.

CONCLUSION:

CONCLUSION In conclusion one must realize that in the pharmaceutical industry there is no margin for error and one must follow good practices in the laboratory to generate accurate, precise and reliable data.

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