Good Laboratory Practice (GLP)-2 Aims of GLP and Accreditation

Aims of GLP and Accreditation 

 GLP AIM 

To make the incidence of false negatives more obvious . GLP helps scientists avoid getting false negatives from their studies because the studies are standardized where they can be and because the variables are well documented.

To make the incidence of false positives more obvious . In the same way that GLP helps avoid false negatives , GLP also helps scientists avoid false positives .

To promote mutual recognition of study data across international frontiers.

 

GLP STUDY PROTOCOL 

GLP defines the working environment under which studies are :

PLANNED

PERFORMED

RECORDED

REPORTED

ARCHIVED 

MONITORED

 

PLANNED which is why great emphasis is given to the study plan ( protocol ) and to possible planned changes throughout the study.

 

PERFORMED  this refers to the Standard Operating Procedures ( SOPs ) which are a GLP requirement.

 

RECORDED  The collection of raw data and the recording of deviations during the study are dealt within the regulation.

 

REPORTED One of the problems pre - GLP was that study reports did not always accurately reflect the study data , so assuring accuracy in the report has become an essential part of GLP.

 

ARCHIVED  as studies may be inspected many years after their completion , it is important that the study data , specimens , samples and reports are correctly stored after the study.

 

MONITORED  monitoring by study staff , quality assurance personnel and national inspections helps assure GLP compliance.

 

 

While GLP is a regulation recovering the quality management of non - clinical safety studies , the concept of Laboratory Accreditation was developed to provide a means for third - party certification of the competence of medical laboratories to perform specific type ( s ) of testing and calibration . Laboratory Accreditation provides formal recognition of competent laboratories , thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands.

National Accreditation Board for Testing and Calibration Laboratories ( NABL ) is an autonomous body under the aegis of Department of Science & Technology , Government of India , and is registered under the Societies Act. NABL has been established with the objective to provide government , industry.associations and industry in general with a scheme for third - party assessment of the quality and technical competence of testing and calibration laboratories . Government of India has authorized NABL as the sole accreditation body for testing and calibration laboratories . NABL has extended its services to clinical and food testing laboratories having strong relevance to the society.

NABL is aimed towards providing an efficient and transparent mechanism to the laboratories and their users . In order to achieve this objective , NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with ISO / IEC 17025 and ISO 15189 2007 for medical laboratories . These services are offered in a non - discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad , regardless of their ownership , legal status , size and degree of independence .

 

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