The document discusses Good Laboratory Practice (GLP) guidelines. It provides an introduction to GLP, including that GLP deals with how laboratory studies are planned, performed, monitored and reported to ensure quality and validity of test data. The history and purpose of GLP are then outlined, noting it was established to prevent fraud and promote standardized, high-quality non-clinical safety testing. Ten GLP principles are also summarized, covering topics like facilities, equipment and management responsibilities. Finally, the scope and current status of GLP in India are briefly addressed.
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: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
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: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
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.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
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.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
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
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
Sudden onset of Disaster-Rehabilitation.pptxselvaraj227
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HORTICULTURE THERAPY, LEVEL OF DEPRESSION, INSTITUTIONALIZED OLD AGE POPULATION, old age home, Preparation of flower bed (session I),The results revealed that the mean score of depression before the intervention was (15.47 ± 3.40). But after the intervention, the results revealed that the mean scores of depression were (11.87±4.71).
Planting of seedling (session II)
Watering (daily)
Weeding (as needed)
Fertilizing (once in 2 weeks)
Walking around
Admiring other participants’ plants
Watching and listening to birds, insects, and butterflies The results revealed that the mean score of depression before the intervention was (15.47 ± 3.40). But after the intervention, the results revealed that the mean scores of depression were (11.87±4.71). it was concluded that the horticulture therapy was found to be effective in reducing the depression level of institutionalized older population in the old age home. In particular, more experimental studies are needed to investigate between-group effects of HT on older adults
Population at risk and its preventive practice of mental health nursingselvaraj227
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Qualitative analysis of data. STRATEGIES FOR ANALYZING OBSERVATIONSselvaraj227
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The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
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Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
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One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
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QA Paediatric dentistry department, Hospital Melaka 2020Azreen Aj
QA study - To improve the 6th monthly recall rate post-comprehensive dental treatment under general anaesthesia in paediatric dentistry department, Hospital Melaka
2. INTRODUCTION
• Good Laboratory Practice (GLP) deals with the
organization, process and conditions under which
laboratory studies are planned, performed,
monitored, recorded and reported.
• GLP data are intended to promote the quality and
validity of test data
4/16/2020 VMRF(DU) NSG19OCT07
3. Con’t
• “If experimental work is conducted in compliance with
GLP, with or without the aid of computer, it should be
possible for an inspector, maybe four or five years
hence, to look at the records of the work and
determine easily why, how and by whom the work was
done, who was in control, what equipment was used,
the results obtained, any problems that were
encountered and how they were overcome”.(Weller)
4/16/2020 VMRF(DU) NSG19OCT07
4. HISTORY
• The term GLP was first used in New Zealand in
1972.
• GLP was instituted in US following cases of fraud
generated by toxicology labs
• As a result of these findings, FDA promulgated the
Good Laboratory Practice (GLP) Regulations, 21 CFR
part 58, on December 22, 1978 (43 FR 59986). The
regulations became effective June 1979.
4/16/2020 VMRF(DU) NSG19OCT07
5. Con’t
• Assure the quality and integrity of safety
Nonclinical laboratory studies
• In 1981 an organization named OECD
(organization for economic co-operation and
development ) produced GLP principles that are
international standard.
4/16/2020 VMRF(DU) NSG19OCT07
6. GLP DEFINITION
• Good Laboratory Practice(GLP) is a quality system
concerned with the organisational process and the
conditions under which non-clinical health and
environmental safety studies are planned ,
performed, monitored, recorded, archived and
reported.
4/16/2020 VMRF(DU) NSG19OCT07
7. GLP
• Clinical lab- Human blood test
• Non clinical lab- Just research, not related to
human patients
• GLP refers to a quality system of management
controls for laboratories where research is taking
place, the labs are not treating humans.
4/16/2020 VMRF(DU) NSG19OCT07
8. PURPOSE OF GLP
1. To promote the development of quality test data
2. Obtain reliable and reproducible data
3. Obtain comparable data between countries
4. Achieve international confidence in study data
5. Avoid repetition of studies
6. Enable reconstruction of studies
4/16/2020 VMRF(DU) NSG19OCT07
9. Con’t
7. Optimise animal conditions
8. Shorten the registration time of the drug
9. To decrease the occurrence of mistake
10. Limit waste resources
11. Ensure high quality of result
12. Ensure comparability of results
13. Promote mutual recognition of results.
4/16/2020 VMRF(DU) NSG19OCT07
10. SCOPE
• GLP is a requirement in regulatory non-clinical
safety testing of the following test items :-
1.Pharmaceutical products-
2. Pesticide products-
3. Cosmetic products-
4. Veterinary products-
5. Food additives-4/16/2020 VMRF(DU) NSG19OCT07
13. GOOD LABORATORY PRACTICE PRINCIPLES
1. Test Facility Organisation and Personnel
2. Quality Assurance Programme
3. Facilities
4. Apparatus, Material, and Reagents
5. Test Systems
6. Test and Reference Items
7. Standard Operating Procedures
8. Performance of the Study
9. Reporting of Study Results
10. Storage and Retention of Records and Materials
4/16/2020 VMRF(DU) NSG19OCT07
14. 1.Test Facility Organisation and
Personnel
1.1 Test Facility Management’s Responsibilities
1.2 Study Director’s Responsibilities
1.3. Principal Investigator’s Responsibilities
1.4 Study Personnel’s Responsibilities
4/16/2020 VMRF(DU) NSG19OCT07
15. 1.1.Test Facility Management’s
Responsibilities
• Responsibilities of management
• Sufficient number of qualified personnel, Ensure the
maintenance of a record
• Job description for each professional and technical
individual.
• Documented approval of the study plan by the Study
Director.
4/16/2020 VMRF(DU) NSG19OCT07
16. 1.2 Study Director’s Responsibilities
• Approve the study plan.
• Amendments to the study plan
• Availability of SOPS to the personnel.
• Raw data generated are fully
• Computerised systems used
• Final report
• Ensure that after completion (including termination)
4/16/2020 VMRF(DU) NSG19OCT07
17. 1.3 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.
4/16/2020 VMRF(DU) NSG19OCT07
18. 1.4 Study Personnel’s Responsibilities
• Knowledgeable Instructions Recording
Responsibilities Health precaution
• Access to the study plan and appropriate Standard
Operating Procedures
• Recording raw data
• Health precautions
4/16/2020 VMRF(DU) NSG19OCT07
19. 2. QUALITY ASSURANCE PROGRAMME
1.Quality assurance personnel
2.Study plan contains the information-verification
3.Conduct inspections Study-based inspections
Facility-based inspections Process-based
inspections.
4.Records of such inspections should be retained
5. Prepare and sign a statement,
4/16/2020 VMRF(DU) NSG19OCT07
20. 3. FACILITIES
3.1 General
3.2 Test System Facilities
3.3 Facilities for Handling Test and Reference Items
3.4 Archive Facilities
3.5 Waste Disposal
4/16/2020 VMRF(DU) NSG19OCT07
21. 3.1 General
• The test facility should be of suitable size,
construction and location
• The design of the test facility should provide an
adequate degree of separation of the different
activities to assure the proper conduct of each
study
4/16/2020 VMRF(DU) NSG19OCT07
22. 3.2 Test System Facilities
• Sufficient number of rooms or areas assure the
isolation of test systems and the isolation of
individual
• There should be storage rooms or areas as needed.
• Areas should be available for the diagnosis,
treatment and control of diseases
4/16/2020 VMRF(DU) NSG19OCT07
23. 3.3 Facilities for Handling Test and
Reference Items
• To prevent contamination or mix-ups, there should
be separate rooms
• Storage rooms or areas for the test items should be
separate from rooms or areas containing the test
systems. They should be adequate to preserve
identity, concentration, purity, and stability, and
ensure safe storage for hazardous substances.4/16/2020 VMRF(DU) NSG19OCT07
24. 3.4 Archive Facilities
• Archive facilities should be provided for the secure
storage and retrieval of study plans, raw data, final
reports, samples of test items and specimens.
• Archive design and archive conditions should
protect contents from untimely deterioration.
4/16/2020 VMRF(DU) NSG19OCT07
25. 3.5 waste disposal
• Handling and disposal of wastes should be carried
out in such a way as not to jeopardise the integrity
of studies.
• This includes provision for appropriate collection,
storage and disposal facilities, and decontamination
and transportation procedures
4/16/2020 VMRF(DU) NSG19OCT07
26. 4. APPARATUS, MATERIAL, AND REAGENTS
• Apparatus, including validated computerised systems,
• Apparatus used in a study should be periodically
inspected,
• Chemicals, reagents, and solutions should be labelled
to indicate identity
• Date and stability should be available.
• The expiry date may be extended on the basis of
documented evaluation or analysis.4/16/2020 VMRF(DU) NSG19OCT07
27. 5. TEST SYSTEMS
5.1 Physical/Chemical
• Physical/chemical data should be suitably
located
• The integrity of the physical/chemical test
systems should be ensured.
4/16/2020 VMRF(DU) NSG19OCT07
28. 5.2 Biological
• Proper conditions should be established and
maintained for the storage
• Newly received animal and plant test systems should
be isolated
• Records of source date of arrival
• Biological test systems should be acclimatised to the
test environment
• Test systems used in field studies should be located so
as to avoid interference4/16/2020 VMRF(DU) NSG19OCT07
29. 6. TEST AND REFERENCE ITEMS
6.1 Receipt, Handling, Sampling and Storage
1. Records including test item and reference item
2. Handling, sampling, and storage procedures should
be identified
3.Storage container(s) should carry identification
information, expiry date, and specific storage
instructions
4/16/2020 VMRF(DU) NSG19OCT07
30. 6.2 Characterisation
• Each test and reference item should be appropriately
identified
• Co-operation between the sponsor and the test facility
• Test item is administered in a vehicle, stability of the
test item in that vehicle should be determined.
• A sample for analytical purposes from each batch of
test item should be retained for all studies except
short-term studies4/16/2020 VMRF(DU) NSG19OCT07
31. 7. STANDARD OPERATING PROCEDURES
1. Test and Reference Items
2. Apparatus, Materials and Reagents
3. Record Keeping, Reporting, Storage, and Retrieval
4. Test System (where appropriate)
5. Quality Assurance Procedures
4/16/2020 VMRF(DU) NSG19OCT07
32. 8. PERFORMANCE OF THE STUDY
8.1 Study Plan
• A written plan should exist prior to the initiation of the study.
• IT should also be approved by management and the sponsor
• Any amendments to the study plan should be justified and
approved.
• Deviations from the study plan should be described,
explained, acknowledged
• For short-term studies a general study plan accompanied by
a study specific supplement may be used.
4/16/2020 VMRF(DU) NSG19OCT07
33. 8.2 Content
1. Identification of the Study, the Test Item and
Reference Item
a). A descriptive title
b). A statement which reveals the nature and purpose
of the study
c) .Identification of the test item by code or named)
the reference item to be used
4/16/2020 VMRF(DU) NSG19OCT07
34. 2. Information Concerning the Sponsor
and the Test Facility
a) Name and address of the sponsor
b) Name and address of the test facilities and test
sites involved
c) Name and address of the study director
d) Name and address of the principal investigator and
the phase delegated by the study director and
under the responsibility of the principal investigator4/16/2020 VMRF(DU) NSG19OCT07
35. 3. Dates
• The date of approval of the study director and by
the management and sponsor and if required by
national regulation /legislation in the country where
the study is being performed.
• The proposed experimental starting and completion
dates.
4/16/2020 VMRF(DU) NSG19OCT07
36. 4. Test Methods
• Reference to the OECD Test Guideline or other test
guideline or method to be used.
5. Issues
a) The justification for selection of the test system;
b) Characterisation of the test system
c) The method of administration and the reason for its
choice
e) Detailed information on the experimental design,4/16/2020 VMRF(DU) NSG19OCT07
37. 8.3 Conduct of the Study
• A unique identification should be given to each study
• The study should be conducted in accordance with the
study plan
• All data generated during the conduct of the study
should be recorded directly
• computerised system design should provide for the
retention of full audit trials to show the changes in the
data without obscuring the original data4/16/2020 VMRF(DU) NSG19OCT07
38. 9. REPORTING OF STUDY RESULTS
9.1 General
1. A final report should be prepared for each study
2. Reports of Principal Investigators
3.The final report should be signed and dated by the
Study Director
4. Corrections and additions to a final report should be in
the form of amendments
5.Reformatting of the final report to comply with the
submission requirements
4/16/2020 VMRF(DU) NSG19OCT07
39. 9.2 Content of the Final Report
1. Identification of the Study, the Test Item and Reference
Item
2. Information Concerning the Sponsor and the Test Facility
3. Dates
4. Statement
5. Description of Materials and Test Methods
6. Results
7. Storage
4/16/2020 VMRF(DU) NSG19OCT07
40. 10. STORAGE AND RETENTION OF
RECORDS AND MATERIALS
• The study plan, raw data, samples of test and reference items,
specimens and the final report of each study.
• Records of all inspections performed by the Quality Assurance
Programme, as well as master schedules.
• Records of qualifications, training, experience and job
descriptions of personnel.
• Records and reports of the maintenance and calibration of
apparatus.
• Validation documentation for computerised systems.4/16/2020 VMRF(DU) NSG19OCT07
41. GLP IN INDIA
• National GLP-compliance Monitoring Authority was
established by the Department of Science & Technology
• Approval of the Union Cabinet on April 24, 2002
• A provisional member of the OECD for GLP.
• India is an Observer to the OECD’s Working Group on
GLP
• The Authority has trained 33 experts in the country as
GLP inspectors.4/16/2020 VMRF(DU) NSG19OCT07
42. CONCLUSION
• GLP is an FDA regulation which is accepted
and approved as international standards by
OECD to avoid the fraud activities of the
testing laboratories
• Every one makes mistake that's why GLP
needed
4/16/2020 VMRF(DU) NSG19OCT07