GOOD LABORATORY PRACTICES

PRESENTED BY:

Iqra Rahat

Assistant Professor

Glocal School of Pharmacy

Glocal University, Saharanpur

GLP: GOOD LABORATORY PRACTICE

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

and drug administration) in 1978.

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What 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.

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WHY WAS GLP CREATED? 4

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

Th a lot of poor lab practices.

Examples of some of these poor lab practices found were

1. standard form , therefore giving wrong

2. measurements.

Incorrect/inaccurate accounts of the actual lab study.

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Purpose of GLPs: 5

• 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.

Scope of GLP

u 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 chemicals

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Objectives of GLP7

True reflection Ensure Honesty International acceptance

GLP makes surethat the data

submitted are atrue reflection of

the results that areobtained during

the study.

GLP also makessure that not toindulge in any

fraud activity bylabs

Promotesinternation

alacceptance

of tests

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Protocols of GLP

Organisation & Personnel – Management’s Responsibilit9ies

❖ 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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Organisation & Personnel – Study Director’s responsib

❖ 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.

11Organisation & Personnel

Principal Investigator’s Responsibilities

❖ Ensures the study is conducted in accordance with GLP

Study Personnel’s Responsibilities

❖ 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

12Quality Assurance ProgrammeAn individual or a group designated by management to assure studies are in compliance with GLP Principles

❖ 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

Facilities

u 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

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Cont …….

Archive facilities

u 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

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15Apparatus, Materials & Reagents

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

Chemicals, 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.

5. Test Systems16

❖ Physical/ Chemical

❖ Biological

6. Test and Reference Items 17

• 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

7.Standard Operating Procedures (SOP) 18

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

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

❑ Test and reference items ❑ Apparatus, materials and reagents ❑ Record keeping, reporting, storage and retrieval ❑ Test system ❑ Quality assurance procedures

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

19Performance of The Study

For 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

20Reporting of study Results

Identification Informatio n

Dates

Statemen t

Result

Descriptio nMaterials

Location of study

plans, specimens, data store

21Storage & Retention of Records

❖ The study plan, raw data, samples of test andreference report

items, specimens and the of each

final 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 in our country

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

❖ Approval of the Union Cabinet on April 24, 2002

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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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Application

Report Submission

• 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.

• The report, prepared by the

inspection team, is put to the Technical Committee for recommendation to Chairman, NGCMA

•CertiGficgagtigogng

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

GLP Certification process

26GLP Application form & certificate

Are we ready for GLP?27

when we do what we write when we

write what we do

We will achieve GLP …

REFERENCE

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

u SANDY WEINBERG. GOOD LABORATORY PRACTICESREGULATION. 4th ed . p 131 - 150

u http/Wikipedia.org/ GLP

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➢ G.E. Paget, Good Laboratory Practice MTP Press Limited, Lancaster 1979. p 56 - 65

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