GOOD LABORATORY PRACTICES

PRESENTED BYANU K THANKACHAN 1ST M. PHARM PHARMACEUTICAL ANALYSISST JAMES COLLEGE OF PHARMACEUTICAL SCIENCES

2GLP: GOOD LABORATORY PRACTICE

GLP is an FDA regulation. GLP is a formal regulation that was created by the FDA (United

states food and drug administration) in 1978.

GLP

GLP

3What is 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.

GLP

4WHY WAS GLP CREATED?

In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States.

They discovered a lot fraudulent activities and a lot of poor lab practices.

Examples of some of these poor lab practices found 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.

GLP

5Purpose of GLPs:

• GLP is to certify that every step of the analysis is valid or Not.

• Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products.

• GLPs have heavy emphasis on data recording, record & specimen retention.

6Scope of GLP

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 products Veterinary drug products and similar

products Industrial chemicalsGLP

GLP

7Objectives of GLPTrue reflection Ensure HonestyInternational acceptanceGLP 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

GLP

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Protocols of GLP

GLP

9Organisation & 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

GLP

10Organisation & 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.

GLP

11Organisation & 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

GLP

12Quality Assurance Programme

Maintains copies of protocols & SOPs

Inspects each laboratories and man at work – Study-based inspectionsFacility-based inspectionsProcess- 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

GLP

13 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

GLP

14Cont …….

Archive facilities

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

Waste Disposal

Appropriate collection, storage & disposal facilities and decontamination procedures

GLP

15Apparatus, Materials & Reagents

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

reagents and solutions should be labelled to indicate identity, 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.

GLP

165. Test Systems

Physical/ Chemical

Biological

GLP

176. Test and Reference Items

• Receipt, handling, sampling and storage

• Characterization.• Known stability of test and reference

items.• Stability of the test item in its vehicle

(container).• Samples for analytical purposes for

each batch

GLP

187.Standard Operating Procedures (SOP)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 reagentsRecord keeping, reporting, storage and retrievalTest system Quality assurance procedures

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

GLP

19Performance of The StudyFor each study, a written plan –• Approved by SD, management, sponsor• Verified for GLP compliance by QAU• If required, national regulation

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

GLP

20Reporting of study Results

Information

Identification

Dates

Statement

Result

DescriptionMaterialsLocation of

study plans, specimens, data store

GLP

21Storage & 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

GLP

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GLP in our country

GLP

23

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

Approval of the Union Cabinet on April 24, 2002

GLP

24Scope 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

GLP

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Application

• The test facilities/ laboratories have to apply in the prescribed application form

Inspection • A pre-inspection of the laboratory is carried out by the GLP inspectors, followed by a final inspection.

Report Submission

• The report, prepared by the inspection team, is put to the Technical Committee for recommendation to Chairman, NGCMA

• GgggggCertification

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

GLP Certification process

GLP

26GLP Application form & certificate

GLP

27Are we ready for GLP?

when we do what we write when we

write what we do

We will achieve GLP …

GLP

28REFERENCE

NARENDRA PRADAP SING SENGER. PHARMACEUTICAL ANALYSIS III. P 48 - 52

SANDY WEINBERG. GOOD LABORATORY PRACTICES REGULATION. 4th ed . p 131 - 150

http/Wikipedia.org/ GLP G.E. Paget, Good Laboratory Practice MTP

Press Limited, Lancaster 1979. p 56 - 65

GLP

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