Dr. Kaushik MukhopadhyayPharmacology, Final year PGT

IPGME&R

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GLP

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.

(OECD, 1997)

What is GLP?

Adamo JE et al. A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure. Acad Med. 2012 Mar;87(3):279–84.

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GLP

Historical Background

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GLP

GLP TIMELINE

1972GLP was first introduced in New ZealandEarly 1970s

Industrial Bio Test Lab case was most notable

FDA became aware of cases of poor laboratory practice all over the US decided to do an in-depth Investigation on 40 toxicology labs. 1978

21 CFR, Part 58

FDA promulgated the Good Laboratory Practice (GLP) Regulations

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GLP

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

1981

An organization named OECD produced GLP principles that are

international standard

International Standard

2002

2011

India becomes full-member for Mutual Acceptance of Data

(MAD) in the OECD's Working Group on GLP

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GLP

Objectives of GLP

True reflection Ensure Honesty International acceptance

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

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GLP

Scope of GLP (OECD)

Principles of GLP apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing -

Pharmaceuticals Pesticides Food and feed additives Cosmetic productsVeterinary drug products and similar productsIndustrial chemicals

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GLP

GLP Principles

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GLP

GLP Principles

01 02 03 04

08 07 06 05

Test Facility Organisation

and Personnel

Quality Assurance

Programme

Facilities Apparatus, Material & Reagents

Reporting of Study Results

Performance of the Study

Test and Reference

Items & SOP

Test Systems

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Storage and Retention of Records and

Materials

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GLP

Organisation & Personnel – Management’s Responsibilities

Ensure sufficient number of qualified personnel, appropriate facilities, equipment, and materials

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

Proper training of personnel to assigned functions

Job description for each professional and technical individual.

To establish and follow SOP

Quality assurance program with designated personnel

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GLP

Organisation & Personnel – Study Director’s responsibilities

Approval of protocols & the study plan including amendments

Ensure QA personnel and study personnel are updated with study plans & SOP

Ensure the follow up of SOPs periodically and take appropriate corrective action

Archiving Raw data, supporting materials and final report.

The individual responsible for the overall conduct of the non-clinical health and environmental safety study

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GLP

Organisation & Personnel

Ensures the study is conducted in accordance with GLP

Recording of all raw data in compliance with the principles of GLP

Deviations from the instructions to be reported the PI or SD

Takes health precautions and personal safety

Study Personnel’s Responsibilities

Principal Investigator’s Responsibilities

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GLP

Quality Assurance Programme

Maintains copies of protocols & SOPs

Inspects each laboratories and man at work – Study-based inspections Facility-based inspections Process- based inspections

Determines any deviation from approved protocol and report to SD, PI & management

Prepare a statements to be included in final report containing dates & types of inspection

An individual or a group designatedby management to assure studies are in compliance with GLP Principles

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GLP

Facilities

Test System Facilities

Sufficient amount of rooms and areas to assure isolation of test systems Adequately protected storage area separate from test systems Areas available for the diagnosis, treatment and control of diseases

Archive facilitiesSecure storage and retrieval of study plans, raw data, final reports & specimen to prevent untimely deterioration

Waste DisposalAppropriate collection, storage & disposal facilities and decontamination procedures

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GLP

Apparatus, Materials & Reagents

Apparatus, including validated computerised systems should be of appropriate design & adequate capacity

Chemicals, reagents and solutions should be labelled to indicate identity, Conc, DOE & storage instructions

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

Should not interfere adversely with the test systems.

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GLP

Test Systems

Physical/ Chemical –

appropriately designed apparatus

Integrity of test systems to be ensured

Biological –

Proper storage, housing and handling conditions

Isolation of newly received animals / plants for evaluation

and acclimatisation

Information regarding identity at the containers

Records of source, date of arrival and arrival condition

Interference & Contamination free test system

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GLP

Test & Reference Items

Records including item receipt, expiry, quantities and used in studies.

Handling, sampling & storage procedures should be identified.

Verification system for sponsor supplied test item.

Stability of test & Reference item under storage and test conditions.

Stability in case of vehicle to be determined.

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GLP

Standard Operating Procedure

1. Test facility should have a written SOP approved by management

2. SOPs should be available wherever applicable e.g.

Test and reference itemsApparatus, materials and reagents

Record keeping, reporting, storage and retrievalTest system

Quality assurance procedures

3. Any deviations from SOP should be documented & acknowledged by SD and PI

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GLP

Performance of The Study

Contents of Study Plan

Identification of the study, the test and reference item Information - sponsor and the test facility, SD, PI Test methods – reference to OECD/other test guidelines Issues – justification of selection Records

Conduct of the Study

Unique identification for each test item According to the study plan Recordings of data should be signed or initialled and dated

For each study, a written plan –•Approved by SD, management, sponsor•Verified for GLP compliance by QAU•If required, national regulation

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GLP

Reporting of study Results

Information Test Facility, SponsorSD, PI, Study Personnel

IdentificationStudyTest & Reference Item

DatesStarting & completion dates

StatementQAP statement with details of inspections

ResultsA summaryAnalysis, Discussions

DescriptionMaterials & methodsRef. to guidelines

StorageLocation of study plans, specimens, data store

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GLP

Storage & Retention of Records

The study plan, raw data, samples of test and reference items, specimens and the final report of each study. Records of all inspections by QAP

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

Records and reports of the maintenance and calibration of apparatus.

Historical files of all SOP

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GLP

GLP in our country

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GLP

NGCMA

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

Approval of the Union Cabinet on April 24, 2002

Full-member for Mutual Acceptance of Data (MAD) in the OECD's Working Group on GLP from March, 2011

The Authority has certified 31 TF in India as GLP compliant

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GLP

Scope of GLP application to NGCMA (India)

Physical-chemical testing

Toxicity studies

Mutagenicity studies

Environmental toxicity studies on aquatic and terrestrial

organisms

Studies on behaviour in water, soil and air, bio-accumulation

Studies on effects on natural ecosystems

Analytical and chemical testing

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GLP

• GLP-compliance Certification (valid for a 3 years)

GLP Certification process

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GLP

GLP Application form & certificate

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GLP

Are we ready for GLP?

when we do what we

write

when we write what we

do

We will achieve GLP …

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GLP

• 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

also erect good international trade and establish good relationship among

the countries

• GLP compliance is monitored in India by NGCMA since 2002.

Summary

Thank You