GLP is a formal FDA regulation created in 1978 that provides principles for conducting laboratory studies in a standard, consistent manner. It aims to ensure quality and integrity of data submitted to the FDA. Key GLP principles include requirements for test facility organization, quality assurance programs, facilities, equipment, test systems, standard operating procedures, study conduct, reporting, and record keeping. GLP helps provide reliable results and protects study integrity and data for regulating products like drugs and pesticides.
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 Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
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 Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
HPLC is a High Performance liquid Chromatography.
High Pressure Liquid Chromatography.
High Priced Liquid Chromatography.
It is column chromatography.
It is Liquid Chromatography.
It is modified from of gas chromatography, it is applicable for both Volatile as well as Non volatile compound.
It can mainly divided by two types 1. Normal phase HPLC 2. Reversed Phase HPLC.
It is having a high resolution and separation capacity.
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
HPLC is a High Performance liquid Chromatography.
High Pressure Liquid Chromatography.
High Priced Liquid Chromatography.
It is column chromatography.
It is Liquid Chromatography.
It is modified from of gas chromatography, it is applicable for both Volatile as well as Non volatile compound.
It can mainly divided by two types 1. Normal phase HPLC 2. Reversed Phase HPLC.
It is having a high resolution and separation capacity.
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
deals with biosafety in medical labs. universal safety precautions included. Includes updated 8 categories and colour coding for BMW management. Being a budding microbiologist, kept it focused on microbiology lab
The 7 Deadly Sins of Quality Assurance and Quality Control - Pharma IQ eBookPharma IQ
The Seven Sins of QA and QC are those transgressions which are detrimental to quality and profitability. You will probably commit some of them every day. We asked the global pharmaceutical community what they thought were the biggest sins that people commit in quality assurance and quality control and the same ones kept coming up over and over again.
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
The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) was established under Section 15(1) of the Prevention of Cruelty to Animals Act 1960.
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. GLP principles include. Organization and Personnel. Management-Responsibilities.
A bioassay is an analytical method to determine the concentration or potency of a substance by its effect on living animals or plants, or on living cells or tissues. A bioassay can be either quantal or quantitative, direct or indirect.
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
This presentation is for the pharmacy, nursing and medical students. this presentation is about brief discussion on good laboratory practice (GLP) for the exam point of view.
OECD principles of Good laboratory practice. this ppt include the basic and necessary information required for OECD GLP guideline . Content is taken from official site
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.
Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. The purpose of testing these items is to obtain information on their safety with respect to human health and environment. GLP is also required for registration purpose and licensing of pharmaceuticals, pesticides, food additives, veterinary drug products and some bio-products.
2. GLP: GOOD LABORATORY
PRACTICE
• GLP is an FDA regulation.
• GLP is a formal regulation that was created
by the FDA (United states food and drug
administration) in 1978.
3. Definition of GLP
• GLP embodies a set of principles that
provides a frame work within which
laboratory studies are planned
performed, monitored, and archived
and reported.
4. 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.
5. 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.
6. 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.
7. 1.Test Facility Organization and
Personnel
Study Personnel Responsibilities
• Should have the Knowledge of the GLP
principles.
• Access to the study plan and appropriate
SOP’s.
• Comply with the instructions of the SOP’s.
• Record raw data.
• Study personnel are responsible for the quality
of their data.
• Exercise health precautions to minimize risk.
• Ensure the integrity of the study.
8. 2.Quality Assurance Program
Responsibilities of the QA Personnel
• Access to the updated study plans and SOP’s.
• Documented verification of the compliance of study
plan to the GLP principles.
• Inspections to determine compliance of the study with
GLP principles.
• Three types of inspection.
– Study-based inspections.
– Facility-based inspections.
– Process-based inspections.
• Inspection of the final reports for accurate and full
description.
• Report the inspection results to the management.
• Statements.
9. 3. Facilities
• Suitable size, construction and location.
• Adequate degree of separation of the
different activities.
• Isolation of test systems and individual
projects to protect from biological
hazards.
• Suitable rooms for the diagnosis,
treatment and control of diseases.
• Storage rooms.
10. 4. Apparatus, Materials and
Reagents
• Apparatus of appropriate design and
adequate capacity.
• Documented Inspection, cleaning,
maintenance and calibration of apparatus.
• Apparatus and materials not to interfere
with the test systems.
• Chemicals, reagent and solutions should be
labeled to indicate identity, expiry and
specific storage instructions.
11. 5. Test Systems
• Physical and chemical test systems.
• Biological test systems.
• Records of source, date of arrival,
and arrival conditions of test systems.
• Proper identification of test systems in
their container or when removed.
• Cleaning and sanitization of containers.
• Pest control agents to be documented.
12. 6. Test and Reference Items
• Receipt, handling, sampling and storage
• Characterization.
• Known stability of test and reference
items.
• Stability of the test item in its vehicle
(container).
• Experiments to determine stability in
tank mixers used in the field studies.
• Samples for analytical purposes for
each batch.
13. 7.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.
14. 7.SOP’s
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.
Definition of raw data.
Analytical methods.
15. 8. Performance of the Study
• Prepare the Study plan.
• Content of the study plan.
› Identification of the study.
› Records.
› Dates.
› Reference to test methods.
› Information concerning the sponsor
and facility.
• Conduct of the study.
16. 9. Reporting of Study Results
• Information on sponsor and test facility.
• Experimental starting and completion
dates.
• A Quality Assurance Program Statement.
• Description of materials and test methods.
• Results.
• Storage (samples, reference items, raw
data, final reports) etc.
17. 10. Storage and Retention of
Records and Materials
– The study plan, raw data, samples.
– Inspection data and master
schedules.
– SOPs.
– Maintenance and calibration data.
– If any study material is disposed of
before expiry the reason to be
justified and documented.
– Index of materials retained.
18. What Good Laboratory Must
Contain.?
• Area should be free from smoke, smell,
dust etc.
• Ensure good ventilation, proper
illumination and prefer natural light.
• Air conditioned the lab with humidity
control.
• Enough space for measuring and testing
instrument.
19. Cont…
• Proper arrangement of testing.
• Take care of all safety points including
proper earthing as well as fire safety.
• Avoid uncleanable spots in floors, walls,
ceiling.
• Establish proper areas for storage of
incoming samples as well as test–completed
samples.
• Also provide sample collection place as
well as packing and disposal of tested
samples.
20. Do this for GLP
• Keep the things at its location after use.
• Store heavy things at bottom & if possible on
Trollies.
• Give name of location to everything.
• Follow “Everything has the place & Everything at
its place” principle.
• Prepare location list & display it.
• Put ladders for things stored on top.
• Identify everything with its name/ purpose.
• Follow “FIFO” to prevent old accumulation for
laboratory chemicals.
21. Benefits of good laboratory
practices.
• It will give better image of company as a
Quality producer in Global market.
• Provide hot tips on analysis of data as
well as measure uncertainty and perfect
record keeping.
• Provide guideline for doing testing and
measurement in detail.
• Provide guidelines and better control
for maintenance of instruments,
environment control, preservation of
test records etc
22. CONCLUSION
• Gives better image of company as a
Quality producer in Global market
Provide hot tips on analysis of data as
well as measure uncertainty and perfect
record keeping & guideline for doing
testing and measurement in detail.
• Finally GLP Provide guidelines and
better control for maintenance of
instruments, environment control,
preservation of test records etc.
23. References
• Good Laboratory Practice. By European
Chemical Industry Ecology and Toxicology
Centre (ECETOC), MonographNo.
1,Brussels October 1979.
• Good Laboratory Practice. by G.E. Paget,
MTP Press Limited, Lancaster 1979.