Under the guidance ofMs. Srujani M.Pharm., (PhD).

Submitted byS. Srilakshmi

M.Pharm. 1st Yeary14mph328

Department Of Pharmaceuticals Analysis ACHARYA NAGARJUNA UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES

GOOD LABORATORY PRACTICES

INTRODUCTION TO GLPDefinition:

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.

ORGLP 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 and Denmark in 1972, and later in the US in 1978 in response to the ”Industrial BioTest Labs” scandal.

It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries.

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 preparationAnalytical method usedProper maintenance of all instrumentsRecord 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 tool enabling also the improvement of study and data quality .

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

PossibilityAccountabilityGLP increases awareness.

CONTINUE…

1. POSSIBILITY:

To reconstruct the whole course of a safety study, even years after it has been performed and even in the absence of persons having been actively involved in the conduct of this specific study.

Ex: All the animals have received the correct dose of the test item at all times, that the correct samples have been taken and analyzed, 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. The documentation needed in the GLP compliant conduct of a study will tell years later who was doing what, and who could be held accountable for mistakes.

3.GLP INCREASE AWARENESS

It awareness of management for the never ending task to strive for optimal quality and transparency of the studies conducted at their test facilities of study directors for the orderly 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 in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms.

The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health 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 that have to be conducted in order to test the safety of the respective test item, but other study types may exclusively be required for one or the other area.

The second point to be observed in the judgment on the necessity for GLP adherence is that these studies are not only conducted to “obtain data on properties and/or its safety”, but that they are “intended for submission to appropriate 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 DirectorThe National Compliance Monitoring Authority

THE MANAGEMENT

A management which is convinced that GLP is a good thing in itself.

Therefore, an essential management responsibility is the appointment and effective organization of an adequate number of appropriately qualified and experienced staff throughout the facility, including those specifically required to perform QA functions.

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

THE QUALITY ASSURANCEThe 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 DIRECTORThe 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 GLPThe 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 in this respect, and in the section on the “Conduct of the Study”, the following instructions are given for the recording of data:

All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialed and 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....