GLP GUIDELINES IN QC LABORATORY AS PER ICH AND USA

PRESENTED BY

ANUSHA .B

Y15MPH431

DEPT . OF PHARMACETICAL ANALYSIS

CONTENTS

INTRODUCTION WHAT IS GLP ? WHY IS GLP NEDDED? OBJECTIVES OF GLP ELEMENTS OF GLP IMPORTANCE AND FUNCTION CONCLUSION REFERENCE

INTRODUCTION• The term GLP was first used in New Zealand in 1972.

• In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard.

Good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality

Definition OF GLP

Good Laboratory Practices(GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

The purpose of GLP

The principle of Good laboratory practice (GLP) : To promote the development of quality and validity of test data used for determining the safety of chemicals, Pharmaceuticals, Food , Cosmetics etc.

Reason behind GLP creation In the 1970s because of concerns about the validity of non-clinical safety data submitted to the Food and Drug Administration (FDA) in the context of New Drug Applications (NDA).

The inspection of studies and test facilities revealed instances of inadequate planning and incompetent execution of studies, insufficient documentation of methods and results, and even cases of fraud.

These deficiencies were made public in the Kennedy-Hearings of the US Congress, and the political outcome of these hearings led to the FDA’s publication of Proposed Regulations on GLP in 1976, with establishment of the Final Rule in June 1979 (21 CFR 58.

For example, replacing animals which had died during a study with new ones (without documenting this fact).

Deleting gross necropsy observations changing raw data in order to “fit the result tables” in the final report.

FAMOUS EXAMPLE

The name of the Lab was Industrial Bio Test. This was a big lab that ran tests for big companies such as Procter and Gamble.

One of the labs that went under such an investigation made headline news.

It was discovered that mice that they had used to test lotion and deodorants had developed cancer and died

Industrial Bio Test lab threw the dead mice and covered results deeming the products good for human use.

Those involved in production, distribution and sales for the IBT lab eventually served jail time.

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 data is traceable.

Promotes international acceptance

OBJECTIVES OF GLP

GMP vs. GLP

Samples Laboratory Processes Results of

AnalysisGood Laboratory Practices

Raw Materials Packaging Materials Manufacturing Processes

Finished Product of Standard Quality

Good Manufacturing Practices

MANAGEMENT

QUALITY ASSURANCE

UNITINSPECTION &

TEST UNIT

HEAD TESTING LABORTATORY

SIMPLEST ORGANIZATION IN AN APPROVED TESTING LABORATORY

GLP stresses the importance of the following main points:

1. Resources: Organisation, personnel, facilities and equipment;

2. Characterisation: Test items and test systems;

3. Rules: Protocols, standard operating procedures (SOPs);

4. Results: Raw data, final report and archives;

5. Quality Assurance: Independent monitoring of research processes

Basic elements in GLP

• Documents Standard Operating Protocols Reports Archiving

• Test and Control Articles Characterization Handling Storage

• Facility Laboratory

infrastructure. Animal care Equipment Reagents

Organization personnel

Management Study director Quality Assurance

ORGANISATIONGLP regulations require clear definitions of the structure of the research organisation and the responsibilities of the research personnel.

This means that the organisational chart should reflect the reality of the institution and should be kept up to date.

Organisational charts and job descriptions give an immediate idea of the way in which the laboratory functions and the relationships between the different departments and posts.

personnel• Qualification of personnel:

The assumptions is that in order to conduct GLP studies with right quality a couple of things are important;

1) There should be sufficient .2) The personnel should be qualified.

Should have the Knowledge of the GLP principles.

• Facility management:

Responsibilities of facility management is well defined. They designate a study director, as well as assure quality assurance unit is available, test and control articles are characterized.

• Study director:

He has overall responsibilities for technical conduct safety studies, as well as interpretation, analysis, documentation and reporting of results.

Quality Assurance unit

QA must be independent of the operational conduct of the studies, and functions as a “witness” to the whole preclinical research process.

It is responsible for monitoring each study to assure management that facilities, equipment, personnel, methods, practices, records, controls, SOPs, final reports (for data integrity), and archives are in conformance with the GLP/GALP

Maintenance & Calibration of Equipment

Equipment shall be adequately inspected, cleaned & maintained.

In a Quality Control lab, all equipment and instruments which are directly or indirectly used for measurement are to be calibrated periodically.

Facility

The facilities should be spacious enough to avoid problems

such as overcrowding, cross contamination or confusion between projects. Utilities (water, electricity etc.) must be adequate and stable.

Laboratory infrastructure.General Chemical Laboratory

The specific requirements are:

Well ventilated, lighted and preferably air conditioned to maintain a temperature of 27 ± 10C.

Instrument Room:

The specific requirements are:

Temperature : 25 ± 10C Relative humidity : 45 ± 5%. Constant supply of Electricity No vibrational disturbances. Separate room for housing semi-micro & microbalances.

All equipment should be suitable for its intended use, and it should be properly calibrated and maintained to ensure reliable and accurate performance.

REAGENTS

EQUIPMENT

Purchasing and testing should be handled by a quality assurance program.

Chemicals, reagent and solutions should be labeled to indicate identity, expiry and specific storage instructions.

Deteriorated or outdated reagents and solutions shall not be used.

Include Date opened

DOCUMENTATION

Results of original measurements, observations, and activities associated with the study which may be needed to verify and evaluate the study.

Which will provide a picture of what actually happened during the course of an activity…

Examples are: Raw Data in Laboratory Notebook, Logbook, Forms, Project Binder/File,

Paper Printout, Electronic Format, All type of records…

WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?

Therefore the document should show:

What was done…

How it was done…

When the work was performed…

Who performed the work…

DOCUMENTATION TYPE… Handwritten Documentation

Entry Into Electronic System

Copying Raw Data

Electronic Data Capture

Standard Operating Procedures (SOP)

Written procedures for a laboratories program. They define how to carry out protocol-specified activities. Most often written in a chronological listing of action steps. They are written to explain how the procedures are suppose to

work Routine inspection, cleaning, maintenance, testing and

calibration. Actions to be taken in response to equipment failure.

Keeping records, reporting, storage, mixing, and retrieval of data

TRAINING AND ANALYST CERTIFICATION

All laboratory personnel (managers, supervisory staffs, analysts, technicians, helpers and others) should have regular training and updated

Some acceptable proof of satisfactory training and/or competence with specific laboratory procedures must be established for each analyst.

Qualification can come from education, experience or additional trainings, but it should be documented

SafetyIn the Quality Control Laboratory, one has to handle a no of hazardous, poisonous and inflammable chemicals and also pathogenic organisms.

Hence the adoption of proper safety measure and use of safety devices are of paramount importance.

The use of mask, gloves, face shields, aprons, gumboots etc. should be made compulsory in the handling of corrosive chemicals.

There should be adequate fire fighting arrangements in the laboratory and personnel should be given proper training for fire fighting. 

Benefits of good laboratory practices.It will give better image of company as a Quality

producer in Global market.

Provide guideline for doing testing and measurement in detail.

Studies done under GLP are definitely more acceptable to Regulatory bodies.

1)Good house-keeping, (2) Quality Manual/Documentation, (3) Quality Policy, (4) Method Validation, (5) Instrumental Validation, (6) System Suitability Tests, (7) Calibration of Equipment/Instruments/ Calibration Schedules/Traceability,

A General Checklist for GLP Implementation

8) Equipment Log Books, (9) Standard Analytical Reference Samples and their Traceability(All related Certificates/Documentation), (10) Archives for Samples and Documents, (11) Specifications for the products investigated

12) Good Vendor Development, (13) Study Director for Projects, (14) Statistical Evaluations, 15) Staff proficiency, Health and Safety,

(16) Procedures for Receiving, Dealing and Disposing Samples,

(17) Environmental monitoring in working

18) Effluent Treatment Monitoring and Control,

Checklist

(19) Participation in Proficiency Testing Programs,

(20) Internal Audits/Checklists,

(21) Management Review Meetings,

(22) Official Audits/Surveillance Audits,

(23) Customer Complaints—Procedures to deal with them and Finding Solutions,

(24) Validation of Computer Systems and Software

25) Continuous Performance Assessment of QA Group,

(26) Raw Data Collection/Traceability of Data

Checklist

27) Continuous upgradation of knowledge of all Personnel through Systematic Training Programs,

(28) Material Safety Data Sheets –Toxicity InformationAntidotes for all Dangerous/Hazardous Chemicals,

(29) First Aid Facilities,

(30) Assignment of Clear and Unambiguous Responsibilities to Various Officers/Personnel,

(31)Standard Operating Procedures,

(32) Sampling Procedures,

Checklist

GLP Certification process

Application

Inspection

Report Submission

Certification

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

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

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

GLP Application form & certificate

• 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.

CONCLUSION

In conclusion one must realize that in the pharmaceutical industry there is no margin for error and one must follow good practices in the laboratory to generate accurate, precise and reliable data.

BIBLOGRAPHY: Pharmaceutical Quality Assurance And Management by

K.P.Bhusari p.g.no:105-112

Drug Regulatory Affairs by Sai Kishore p.g.no:292-301

Hand book of good laboratory practices by WHO

Thank you

SO START GLP