Good Laboratory Practices (GLP) are quality standards for designing, conducting, recording, and reporting non-clinical research studies that generate data as safety and efficacy information for health or environmental regulations. GLP was developed to increase quality and validity of non-clinical safety studies by defining roles, responsibilities, standard operating procedures, and documentation requirements. Key elements of GLP include management and quality assurance systems, personnel qualifications, facility organization and maintenance, test and control article characterization, standard operating procedures, documentation, and reporting.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
1) GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
2) WHY 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.
3) Purpose 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.
4)GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
5) GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
6) "Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.
The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived). The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms.
The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
Good Laborarory Practices. Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance.
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2. INTRODUCTION
WHAT IS GLP ?
WHY IS GLP NEDDED?
OBJECTIVES OF GLP
ELEMENTS OF GLP
IMPORTANCE AND FUNCTION
CONCLUSION
REFERENCE
3. • 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
4. 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.
5. 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.
6. 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.
7. 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.
8. 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
9. 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.
10. 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
11. GMP vs. GLP
Samples Laboratory Processes Results of
Analysis
Good Laboratory Practices
Raw Materials Packaging
Materials
Manufacturing Processes
Finished
Product of
Standard
Quality
Good Manufacturing
Practices
13. 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
14. 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
15. ORGANISATION
GLP 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.
16. 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.
17. • 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.
18. 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
19. 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.
20. 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.
21. 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.
22. 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
23. 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…
24. 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…
26. 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
27. 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
28. Safety
In 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.
29. 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.
30. 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
31. 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
32. (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
33. 27) Continuous upgradation of knowledge of all Personnel
through Systematic Training Programs,
(28) Material Safety Data Sheets –Toxicity Information
Antidotes 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
34. 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)
36. • 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.
37. 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.
38. 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