Good Laboratory Practice (GLP)-1 Introduction to Basics of GLP and Accreditation

  Introduction to Basics of GLP and Accreditation

Good Laboratory Practice ( GLP ) regulations became part of the regulatory landscape in response to following malpractices in research and development ( R & D ) activities of pharmaceutical companies and contract facilities used by them : 

• Poorly - trained study directors and study personnel

• Poorly - designed protocols

 • Protocols not followed prescribed procedures not conducted as

• Raw data badly collected not correctly identified without traceability not verified or approved by responsible persons

• Lack of standardized procedures

• Poor animal husbandry

• Inadequate characterization of test items and test systems

• Inadequate resources

• Equipment not properly calibrated or otherwise qualified

• Reports not sufficiently verified , not an accurate account of the actual study , not a proper reflection of raw data

• Archives inadequate 

 

The malpractice included some cases of fraud , but by far the most important aspect of poor practice was the lack of proper management and organization of studies required for completion regulatory dossiers which led to the Good Laboratory Practice ( GLP ) regulations . First the US FDA then the US Environmental  Protection Agency ( EPA ) instituted GLP regulations , and eventually many nation of the world followed suit .

 

In 1981 , the Organization for Economic Co - operation and Development ( OECD ) also published GLP principles . So far 30 countries ( the member states of the OECD ) have signed agreements that make the OECD GLP principles binding on them . Though they have not dominated the international scene but effectively made the OECD Principles an international text .

 At present , India enjoys the status of Provisional Member of the OECD for GLP . Head , National GLP programme has been nominated by the Department as an Observer to the OECD's Working Group on GLP and National Coordinator for OECD's Test Guidelines Programme . National GLP Compliance Monitoring Authority was set up in April 2002 with the approval of the Cabinet and it functions under the administrative control of Department of Science and Technology ( DST ) . The National GLP Compliance Monitoring Authority functions as per OECD norms and principles and efforts are being made to achieve OECD recognition , so that India acquires full - member status in OECD.

GLP - compliance certification is voluntary in nature . Industries / test / facilities / laboratories dealing with chemicals and looking for approval from regulatory authorities before marketing them may apply to the National GLP Compliance Monitoring Authority for obtaining GLP certification.

The intent of GLP was to regulate the practices of scientists working on the safety testing of prospective drugs . With the obvious potential impact on consumers and patients recruited for clinical trials , the safety of drugs became a key issue and GLP was seen as a means of ensuring that scientists did not invent or manipulate safety data and a means of ensuring that GLP compliant studies are properly managed and conducted . Hence GLP became the champion of the consumer , the regulatory safeguard , the guarantee that the safety data were being honestly reported to the registration or receiving authorities as the basis of a decision whether or not to allow a new drug onto the matket . GLP was imposed on the industry by regulatory authorities , in the same way as good manufacturing practice ( GMP ) had been before , and good clinical practice ( GCP ) was to be afterwards.

 

 

 BASIC PRINCIPLES OF GLP AND ACCREDITATION 

The aim of the regulation is to encourage scientists to organize the performance of their studies in a way which promotes the quality and validity of the test data.

 GLP PRINCIPLES

• The purpose is not to assess the intrinsic scientific value of a study.

• GLP principles are a set of organizational requirements.

• Point out the important difference between the science of study and the organization of a study.

• GLP does not rell scientists what tests to perform , or what the scientific contents of a study plan ( protocol ) should be . There are other regulations for this aspect of studies ( scientific guidelines ).

 

What GLP requires is that the scientists responsible for the organization of studies implement clear organization structures in compliance with GLP so that the test data are more reliable.

Main Goal:

To help scientists obrain results which are:

•  Reliable

• Repeatable 

• Auditable

• Recognized by scientists worldwide .

 

 

 

 

https://drive.google.com/file/d/1DIAkw4iQ6GmwPq-mYW3pLWPWGH-q1hD_/view?usp=share_link

.