GOOD LABORATORY PRACTICE CHETANA

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By: alluprakash88 (99 month(s) ago)

hi ms chetana could u please mail me your glp ppt please... my i.d was alluprakash@rocketmail.com

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chetana goswami M.sc (Biotech):

chetana goswami M.sc (Biotech) GOOD LABORATORY PRACTICE (GLP)

GLP: GOOD LABORATORY PRACTICE:

GLP: GOOD LABORATORY PRACTICE GLP is an FDA regulation. Definition : GLP embodies a set of principles that provides a framework within which laboratory studies are planned performed, monitored, reported and archived.

WHAT IS GLP:

WHAT IS GLP GLP = G ood L aboratory P ractice OECD Principles on Good Laboratory Practice What is the OECD?

The Organization for Economic Co- operation and Development : OECD:

The Organization for Economic Co- operation and Development : OECD Intergovernmental organization 30 industrialized countries Meet to co-ordinate and harmonize policies. Discuss issues of mutual concern Work together to respond to international problems.

The purpose of GLP:

The purpose of GLP The principle of Good laboratory practice (GLP) : to promote the development of quality and validity of test data used for determining the safety of chemicals and chemicals product.

HISTORY:

HISTORY GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978. Although GLP originated in the United States , it had a world wide impact. In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard.

WHY WAS GLP CREATED?:

WHY WAS GLP CREATED? In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. FDA decided to do an in-depth investigation on 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were Equipment not been calibrated to standard form , therefore giving wrong measurements.

CONT….:

CONT…. Development of quality test data Mutual acceptance of data Avoid duplication of data Protection of human health and the environment

Scope of principle of GLP:

Scope of principle of GLP GLP should be applied to the non-clinical safety testing of test items: Pharmaceutical product Pesticides product Cosmetic product Food additives Industrial chemical

MISSION OF GLP:

MISSION OF GLP Test systems Archiving of records and materials. Apparatus, material and reagent facilities. Quality assurance programs. Performance of the study. Reporting of study results. Standard operating procedures (SOP)

Standard Operating Procedures (SOP):

Standard Operating Procedures (SOP) Written procedures for a laboratories program. They define how to carry out protocol-specified activities . They are written to explain how the procedures are suppose to work

SOP:

SOP Routine inspection, cleaning, maintenance, testing and calibration. Actions to be taken in response to equipment failure. Analytical methods Definition of raw data Keeping records, reporting, storage, mixing, and retrieval of data

Instrumentation Validation:

Instrumentation Validation This is a process necessary for any analytical laboratory. Data produced by “faulty” instruments may give the appearance of valid data. The frequency for calibration, re-validation and testing depends on the instrument and extent of its use in the laboratory.

Apparatus, Materials and Reagents:

Apparatus, Materials and Reagents Apparatus of appropriate design and adequate capacity documented Inspection, cleaning, maintenance and calibration of apparatus. Calibration to be traceable to national or international standards Apparatus and materials not to interfere with the test systems Chemicals, reagent and solutions should be labeled to indicate identity, expiry and specific storage instructions.

Reagents and Solutions cont:

Reagents and Solutions cont Requirements: Reagents and solutions shall be labeled Deteriorated or outdated reagents and solutions shall not be used Include Date opened Stored under ambient temperature Expiration date

Laboratory Certification:

Laboratory Certification Adequate space Ventilation Storage Hygiene

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