Under the guidance of

Ms. Srujani M.Pharm., (PhD).

Submitted by

S. Srilakshmi

M.Pharm. 1st Year

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Department Of Pharmaceuticals AnalysisACHARYA NAGARJUNA UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES

GOOD LABORATORY PRACTICES

INTRODUCTION TO GLP

Definition:

GLP may be defined as a body rules, operating

procedures, and practices established by a given

organization, that are considered to be mandatory with a

view to ensuring quality and correctness in the results

produced by a laboratory.

OR

GLP is a quality system concerned with the

organizational process and conditions under which non-

clinical health and environmental safety studies are

planned, performed, monitored, recorded, archived and

reported.

HISTORY OF GLP

GLP was first introduced in New Zealand andDenmark in 1972, and later in the US in 1978 inresponse to the ”Industrial BioTest Labs” scandal.

It was followed a few years later by theOrganization for Economic Co-operation andDevelopment (OECD) Principles of GLP in 1992;the OECD has since helped promulgate GLP to manycountries.

ELEMENTS OF GLP

STANDARD OPERATING PROCEDURE (SOP)

Usually provide an elaborated description of various on-

going activities carried out Analytical laboratory.

Examples:

Sample handling and preparation

Analytical method used

Proper maintenance of all instruments

Record keeping.

QUALITY ASSURANCE UNIT (QAU)

QAU is entirely responsible for assuring GLP being

implemented effectively.

The prime responsibilities that are exclusively fall within

the domain of QAU are -

oImplementation of quality procedures.

oAssessment of quality procedures on a continual basis.

oAudits of the laboratory periodically.

OBJECTIVES OF GLP

Adopt good and safe operating procedures and

recording systems.

Prevent human errors in the performance of the

job.

Prevent equipment errors in measurements.

Prevent unsafe and hazardous acts which could

affect individuals and/or properly.

Improve efficient performance of the job.

THE IDEA BEHIND GLP

It belongs to the functions of the respective

authorities to make sure that the safety and the

environment is proven safety claims can be verified.

A regulatory authority may then obtain verification of

such an experimental result by either two ways.

1. It self

2. Step-by-step

CONTINUE…

The GLP principles are designed as a toolenabling also the improvement of study and dataquality .

All these requirements can be summarized in threeissues that are central to the ideas behind GLP.

PossibilityAccountabilityGLP increases awareness.

CONTINUE…

1. POSSIBILITY:

To reconstruct the whole course of a safety study, even yearsafter it has been performed and even in the absence ofpersons having been actively involved in the conduct of thisspecific study.

Ex: All the animals have received the correct dose of the testitem at all times, that the correct samples have been taken andanalyzed, and the actual data that had been collected.

These report submitted to the Regulatory Authority.

CONTINUE…

2.ACCOUNTABILITY

It is very closely connected with the first one. Thedocumentation needed in the GLP compliant conduct of astudy will tell years later who was doing what, and whocould be held accountable for mistakes.

3.GLP INCREASE AWARENESS

It awareness of management for the never ending task tostrive for optimal quality and transparency of the studiesconducted at their test facilities of study directors for theorderly performance of the studies they are to control.

SCOPE OF GLP

The scope of GLP as it is defined in the OECD Principles,and which states that GLP encompasses:

“the non-clinical safety testing of test items contained inpharmaceutical products, pesticide products, cosmetic products,veterinary drugs as well as food additives, feed additives, andindustrial chemicals. These test items are frequently syntheticchemicals, but may be of natural or biological origin and, insome circumstances, may be living organisms.

The purpose of testing these test items is to obtain data ontheir properties and/or their safety with respect to humanhealth and/or the environment.” (OECD, 1998).

THE AREAS OF APPLICATION

GLP is applicable to safety studies in two major areas:

1. Effects on human health2. Effects on the environment

These two areas may share some types of studies thathave to be conducted in order to test the safety of therespective test item, but other study types may exclusivelybe required for one or the other area.

The second point to be observed in the judgment on thenecessity for GLP adherence is that these studies are notonly conducted to “obtain data on properties and/or itssafety”, but that they are “intended for submission toappropriate regulatory authorities”.

CONTINUE…

The applicability of GLP to “human health and environmental

safety” testing spells out yet another facet of this delimitation which

may give rise to a number of questions. Laboratory testing that is

performed in a non safety-related way.

Example:

The physical-chemical parameters of a pharmaceutical chemical

substance might thus not be considered as related to an assessment

of human health risks. For a pesticide or another environmental

substance, however, parameters like their vapour pressure, their

acid-base equilibrium constant or their water/octanol partition

coefficient, all of which will determine the nature and extent of

environmental dissipation, and accumulation, will certainly be

safety-related data that have to be generated under GLP.

CONTINUE…

The data to be generated under GLP have to have a connection

to the assessment of safety for either of the two fields of

human health or for the environment. In this regard there

are apparent differences between these two fields.

The necessity to follow the strict regulations of GLP will be

determined by the two basic principles of the scope of GLP –

the safety-relatedness of the investigation and the

foreseeable submission to an Regulatory Authority – the

interpretation of which may, however, under different

circumstances lead to different answers and conclusions.

THE PILLARS OF GOOD LABORATORY PRACTICES

Good Laboratory Practice is based on four pillars

which have to support the implementation and daily

observance of its Principles:

The Management

The Quality Assurance

The Study Director

The National Compliance Monitoring Authority

THE MANAGEMENT

A management which is convinced that GLP is agood thing in itself.

Therefore, an essential management responsibility isthe appointment and effective organization of anadequate number of appropriately qualified andexperienced staff throughout the facility, includingthose specifically required to perform QA functions.

And this management responsibility brings us to thesecond pillar of Good Laboratory Practice.

THE QUALITY ASSURANCE

The second pillar of this building, named GLP, is the Quality

Assurance, an internal system for ensuring that the Principles of

GLP are observed.

The compliance with the GLP standards in the everyday work

at a test facility can only be as good as the critical

observational capability of the Quality Assurance inspector

on the one hand, and also only as good as the ability of the

Quality Assurance manager to succeed in carrying through

any objections to the way GLP is handled by individual

persons.

Quality Assurance may thus be regarded as the prolonged arm

of management, which exercises its control over the GLP

compliance within the test facility.

THE STUDY DIRECTOR

The third pillar of the GLP system consists of

one single person! The Study Director is the one

single point of study control and the one single

person on whom the whole study hinges from the

beginning to the end.

The Study Director is usually the scientist

responsible for study plan design and approval,

as well as for overseeing data collection, analysis

and reporting, and for drawing the final overall

conclusions from the study.

NATIONAL COMPLIANCE MONITORING AUTHORITY

It is the National Compliance Monitoring Authority for the

international recognition and mutual acceptance of studies and

test data.

This Recommendation sets out the basic characteristics of the

procedures for monitoring compliance with the GLP

Principles, and following this Recommendation two guidance

documents on “Compliance Monitoring Procedures for

GLP” and on the “Conduct of Laboratory Inspections and

Study Audits”, both directed at the National Monitoring

Authorities, were issued.

This fourth pillar of GLP is the comparability of the

monitoring procedures, mutual trust is achieved and the

mutual acceptance of safety test data will be possible.

WHERE CAN GLP BE PROFITABLY APPLIED…?

The term “Good Laboratory Practice” is restricted to

apply to such test facilities only, which are performing

“human health and environmental safety studies”, studies

which furthermore have to be submitted to a Regulatory

Agency for assessment. It is evident that not every

laboratory would fulfil these conditions.

Outside the field of “non-clinical human health and

environmental safety” testing, where GLP has to apply,

official recognition should be based on quality standards

other than GLP, since GLP is absolutely confined to the

said area.

PRINCIPLES OF GLP

The important principles are not new, nor are they unknown; they

can be summarized as follows:

There should be a unique identification for the study and all of its

parts.

All original observations in a study should be immediately, clearly

and legibly recorded.

All records should be in the form of bound notebooks or on

continuously numbered sheets.

All entries and corrections to them should be dated and initialed.

Records related to the test system itself should be gathered and

retained.

Specimens should be clearly identified so as to allow full

traceability.

At the end of a study, all raw data should be assembled, catalogued

and archived.

CONTINUE…

The GLP Principles are much more demanding inthis respect, and in the section on the “Conduct ofthe Study”, the following instructions are given forthe recording of data:

All data generated during the conduct of thestudy should be recorded directly, promptly,accurately, and legibly by the individual enteringthe data. These entries should be signed or initialedand dated.

CONTINUE…

The possibilities inherent in the applicable

control mechanisms might subsequently provide

the means for judging the shortcomings of the

present activities and for improving the scientific

quality of the future work.

REFERENCES

Good Laboratory Practice – the Why and

the How by Jürg P. Seiler

THANK YOU....