WELCOME GLP (GOOD LABORATORY PRACTICES)

GOOD LABORATORY PRACTICES

1.Introduction2.History 3.OECD principles 4.GLP at glance 5.GLP in India

1.Introduction

1.INTRODUCTION:

What is a good laboratory practice?

Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

Drugs-Companies

Laboratories

Government and Company

Hazard assesmentInternational trade.

GLP

DATA

Non-clinical health and environmental safety studies

Experiments Not in a hospital

Human beings Enviromnment

2. HISTORY

The word GLP- Newzealand

GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. Industrial Bio Test Lab (IBT) was the most notable case, where thousands of safety tests for chemical manufacturers were falsely claimed to have been performed or were so poor .

1972

1976

GLP was first introduced in New Zealand in 1972.

GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies.

Industrial Bio Test Labs (IBT) was the most notable case, where thousands of safety tests for chemical manufacturers were falsely claimed to have been performed or were so poor.

Famous example:In the early 70’s FDA became aware of cases of poor laboratory practice all over the US.

FDA decided to do an in-depth investigation on 40 toxicology labs.

They discovered a lot fraudulent activities and a lot of poor lab practicesTheir findings were: 1. Equipment not been calibrated to standard form , therefore

giving wrong measurements.2. Incorrect/inaccurate accounts of the actual lab study.3. Inadequate test systems.

One investigation- made headline news

The name of the Lab was Industrial Bio Test. Ran tests for big companies-

Procter and Gamble.

It was discovered that mice that they had used to test cosmetics such as lotion and deodorants had developed cancer and died.

Industrial Bio Test lab threw the dead mice and covered results deeming the products good for human consumption.Those involved in production,distribution and sales for the lab eventually served jail time.

IBT

GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. As a result of these findings, FDA promulgated the Good Laboratory Practice (GLP) Regulations, 21 CFR part 58, on December 22, 1978 (43 FR 59986). The regulations became effective June 1979.

As a international standard:

In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard. of the OECD Council, data generated in the testing of chemicals in one OECD Member Country, in accordance with OECD Test Guidelines and the Principles of GLP are accepted in all other OECD Member Countries.

USA FDA

OECDINTERNATIONAL LEVEL

COUNTRY LEVELORIGINATOR FOR THE GLP

INSTITUITIONS -GLP

GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study.

GLP also makes sure that not to indulge in any fraud activity by labs.

Promotes international acceptance of tests.

OBJECTIVES OF GLP

3.GOOD LABORATORY PRACTICE PRINCIPLES

1.Test Facility Organisation and Personnel2. Quality Assurance Programme3. Facilities4. Apparatus, Material, and Reagents5. Test Systems6. Test and Reference Items7. Performance of the Study8. Reporting of Study Results9. Storage and Retention of Records and Materials

GOOD LABORATORY PRACTICE - PRINCIPLES

1.Test Facility Organisation and Personnel

A. Test Facility Management’s Responsibilities B. Study Director’s Responsibilities C. Principal Investigator’s Responsibilities D. Study Personnel’s Responsibilities

A.Test Facility Management’s Responsibilities.

Responsibilities of management as defined by these principles of good laboratory practice.

Sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the Study

Ensure the maintenance of a record of the qualifications, training, experience.

Job description for each professional and technical individual.

Documented approval of the study plan by the Study Director.

B.Study Director’s Responsibilities. approve the study plan. Any amendments to the study plan by

dated Signature. Availability of SOPS to the personnel. Raw data generated are fully

documented and recorded. Computerised systems used in the study

have been validated. Sign and date the final report to indicate

acceptance of responsibility for the validity of the data.

Ensure that after completion (including termination) of the study, the study plan,the final report, raw data and supporting material are archived.

C.Principal Investigator’s Responsibilities

The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice

Knowledgeable

Instructions

Recording

Health precaution

s

Responsibilities

2.Quality Assurance Programme1.Quality assurance personnel

2.Study plan contains the information-verification

3.conduct inspections

Study-based inspections

Facility-based inspections

Process-based inspections.

4.Records of such inspections should be retained

3. Facilities1.Test system facilities

Sufficient number of rooms or areas assure the isolation of test systems and the isolation of individual projects involving substances or organisms known to be or suspected of being biohazardous.

There should be storage rooms or areas as needed for supplies and equipment.

Areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that there is no unacceptable degree of deterioration of test systems.

Archive Facilities

Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens.

Archive design and archive conditions should protect contents from untimely deterioration.

Handling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. This includes provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures

waste disposal

4. Apparatus, Material, and Reagents Apparatus, including validated computerised systems,

used for the generation, storage and retrieval of data, and for controlling environmental factors relevant to the study.

Apparatus used in a study should be periodically

inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures.

Apparatus and materials used in a study should not interfere adversely with the test systems.

Chemicals, reagents, and solutions should be labelled to indicate identity (with concentration if appropriate), expiry date and specific storage instructions. Information concerning source, preparation date and stability should be available. The expiry date may be extended on the basis of documented evaluation or analysis.

5&6.Test Items and test systems and characterisation

Drugs manufactured in the MNCs

BioTestingLaboratory

Send to the labs for quality assurance and also testing for the toxicity aganist to the mammals. and environment.

2.Characterization:

Test item-product going to be tested –composition, stability, chemical nature solubility, new formula or modified previous product formula, identity, potency, impurity profile,

Test system-to which animal is going to be administere

Results submitted to the FDA-US Government and OECD (International standards).

Further release into the market and reproduction.

7.Performance of the Study

1. Study Plan2. Content of the Study Plan3. Dates4. Test Methods5. Issues (where applicable)6. Records.7. A list of records to be retained.8. Conduct of the Study.

8.Reporting of Study Results

1. Content of the Final Report2. Identification of the Study, the Test Item and Reference

Item3. Information Concerning the Sponsor and the Test Facility4. Dates5. Statement6. Description of Materials and Test Methods7. Results8. Storage

9. Storage and Retention of Records and Materials

The study plan, raw data, samples of test and reference items, specimens and the final report of each study.

Records of all inspections performed by the Quality Assurance Programme, as well as master schedules.

Records of qualifications, training, experience and job descriptions of personnel.

Records and reports of the maintenance and calibration of apparatus.

Validation documentation for computerised systems.

GLP AT A GLANCE

Product manufacturing

Testing laboratories

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1.Test Facility Organisation and Personnel2. Quality Assurance Programme3. Facilities4. Apparatus, Material, and Reagents5. Test Systems6. Test and Reference Items7. Performance of the Studynon 8. Reporting of Study Results9. Storage and Retention of Records and Materials.

Data submission to the regulated authorities - Government ,FDA

SAFETY NON SAFETY

Relesed into the market

OECD PRINCIPLES OF GLP

INTERNATIONAL TRADE

GLP IN OUR COUNTRY

INDIA

National GLP-compliance Monitoring Authority was established by the Department of Science & Technology

approval of the Union Cabinet on April 24, 2002 A provisional member of the OECD for GLP. India is an Observer to the OECD’s Working Group on

GLP The Authority has trained 33 experts in the country as

GLP inspectors.

GLP-COMPLIANCE CERTIFICATION The test facilities/laboratories have to apply in the prescribed application form

GLP-compliance Certification is valid for a period of three years

The report, prepared by the inspection team, is put to the Technical Committee for recommendation to Chairman, National GLP- Compliance Monitoring Authority

After the application for GLP certification is received, a pre-inspection of the laboratory is carried out by the GLP inspectors, followed by a final inspection.

Dr D R Prasada Raju Head /Scientist G

drpraju@nic.inNational GLP Compliance Monitoring Authority

Department of Science and TechnologyTechnology Bhawan, New Mehrauli Road,

New Delhi-110 016 (Telefax 011-26510686)

Mrs Ekta KapoorScientist D

Department of Science and TechnologyTechnology Bhawan, New Mehrauli Road,

New Delhi-110 016 (Phone: 011-26590242)E-mail: -ektakapoor.glp@gmail.com 

HEAD OF NGCMA:

Our aim : is to be get the status of full membership in the near future so that the Indian industries do not have to get their test facility (products) certified from safety angle by other GLP monitoring authorities and do not lose on the trade front.

Conclusion

GLP is an FDA regulation which is accepted and approved as international standards by OECD to avoid the fraud activities of the testing laboratories for pesticides , pharmaceuticals , food additives , dyes, to save the human and environmental health and also erect good international trade and establish good relationship among the countries .

Thanks a lot

PRESENTED BY S.SRINIVAS NAIKID .No:13-503-010