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 (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
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
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 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.
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
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.
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.
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
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.
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2. GLP: GOOD LABORATORY PRACTICES
GLP is a FDA regulations.
GLP was first introduced in New Zealand & Danmark in 1972 & Later in US in
1978.
It regulates the process and condition under which clinical & non-clinical research
is conducted. GLP also govers how these research facilities should be maintain.
GLP embodies a set of principle that provides a frame work within which
laboratory studies are planned, performed, monitored and archived report.
3. why GLP was created?
In the early 70’s FDA becomes awares of case of poor laboratory
practice all over the US.
They discovered a lot fraudulent activities and a lot of poor lab
practices.
Examples of some of these poor lab practices found were :
1. Equipments not be calibrates to standard form therefore giving
wrong measurements.
2. Incorrect/ inaccurate account of the actual lab study.
3. Inadequate test system.
4. PurposeofGLP
To promote the quality of test date.
To avoid duplicate of research.
To improve the protection of human health and environment.
To facilate international acceptance of test data.
To prevent the creation of technical trade barriers.
5. Who& oecdmembers
WHO has published standard for:
Good Manufacturing practices (GMP) covering the manufacturing of drug products.
Good Clinical Practice (GCP) covering clinical trials in human to establish efficacy and
safety.
OECD(Organization of Economic Cooperation and Development) members manage
quality standard for:
Non-clinical testing for the safety of potential products.
6. ScopeofGLP
GLP is requirements in regulatory non-clinical safety testing of the following
test items:
1. Pharmaceuticals products .
2. Cosmetic products.
3. Veterinary products.
4. Food additives.
5. Feed additives.
6. Industrial chemicals.
7. Elements of GLP
Test facilities management and personnel.
Quality assurance programme.
Facilities.
Apparatuses, materials and reagents
Test & reference items.
Test system.
Standard operating procedures.
Performance of study results.
Reporting of study results.
storage and retention of records & materials.
8. Testfacilitiesmanagementandpersonnel
Test Facility Management’s Responsibilities :
Each test facility management should ensure that these Principles of Good
Laboratory Practice are complied with, in its test facility.
Study Director’s Responsibilities :
The Study Director is the single point of study control and has the responsibility
for the overall conduct of the study and for its final report.
Principal Investigator’s Responsibilities :
The Principal Investigator will ensure that the delegated phases of the study
are conducted in accordance with the applicable Principles of Good Laboratory
Practice.
9. Qualityassuranceprogramme
The test facility should have a documented Quality Assurance Programme to
assure that studies performed are in compliance with these Principles of Good
Laboratory Practice.
The Quality Assurance Programme should be carried out by an individual or by
individuals designated by and directly responsible to management and who are
familiar with the test procedures.
This individual(s) should not be involved in the conduct of the study being
assured.
10. Standardoperatingprocedures
Standard Operating Procedures should be available for, but not be limited to, the following categories of test facility activities.
The details given under each heading are to be considered as illustrative examples.
Test and Reference Items:
Receipt, identification, labelling, handling, sampling and storage.
Apparatus, Materials and Reagents:
1. Apparatuses
Use, maintenance, cleaning and calibration.
2. Computerised systems
Validation, operation, maintenance, security, change control and back-up.
3. Materials, Reagents and Solutions.
Preparation and labelling.
Record Keeping, Reporting, Storage, and Retrieval.
Test System (where appropriate).
Quality Assurance Procedures.
11. Advantage and disadvantages of GLP
Advantage of GLP:
Increase confidence in the reliability and
trustworthiness of laboratory data.
Increase production of right first time
results.
Increase overall productivity.
Increase laboratory reputation.
Reduce need for re-work.
Reduce time spent in non-revenue earning
investigation.
Disadvantages of GLP:
More man power is required.
Expensive process.
Time consuming process.
12. Conclusion
GLP is an internationally accepted, stringent regulation followed in the process of
determination of Safety and assessment of potential hazards in pharmaceuticals,
veterinary drugs, pesticides and feed additives. It carries paramounts importance in
proving the non-clinical safety of the product to the health regulatory authorities in
countries where the product requires to be marketed.