Dr.Nagraj sir 1. Division on Earth and Life Studies. temperature with in the range of 180 -290c relative humidity- 30-70% throughout the year • for large animal comfortable zone-18-37°˚c POWER & LIGHTING- the electrical system should be safe and provide appropriate lighting and a sufficient no. conduct research and drug product development studies at a level comparable to that in other parts of the world. These factors may be mistaken for the effects of the treatment. While there are significant differences in how these have been developed and implemented in each country, they are base… The term refers to a quality system of management controls for laboratories where research is taking place. 12.2 Good Laboratory Practices for Nonclinical Laboratory Studies. 4 Modification in the timelines for processing of applications in the office of CPCSEA. 2 3. Looks like you’ve clipped this slide to already. Presented by Each country recognizes modern society's ethical concerns over the use of animals in research and each has developed their own regulatory framework to support the humane care and use of laboratory animals. Experimental surgery, care of surgical patients, and specific surgical models and procedures. Veterinary care. of power outlets. They set the standard by which studies are designed, conducted, and reported to assure reproducibility, accuracy, and consistency. With a physical land area of just over 700 square kilometers and a population of around 5.4 million people, this densely populated island has abundant tropical flora, parks, and g… • Facilitate research while maintaining good … 58 0 obj <> endobj The following information addresses the legal requirement for cosmetic safety and … After performing an experiment, you should always wash your hands with soap and water. Good Clinical Laboratory Practice Guidelines is now published by WHO/TDR under the terms of an agreement between WHO and BARQA. Good Laboratory Practice (GLP) is to promote technology and ... CPCSEA (2003). Recognized guidelines for the care and use of the animals were followed (CPCSEA guidelines for laboratory animal facility, 2003) [15]. ... good laboratory practice. Ethics guide. GM. However, with changing trends in teaching methods and practices, it is increasingly felt that animals should not be sacrificed just to acquire skills and techniques of experimentation. xref These regulations set the minimum basic … %%EOF 123. conduct of animal studies, and the presentation of animal study … CRISP. 0 CPCSEA Guidelines 2 FOREWORD A number of animals are used in this country for conducting a variety of experiments. There has been a long feld need to prescribe guidelines and procedures for animal experimentation covering all aspects. PODCAST. See our User Agreement and Privacy Policy. The demand for this series was so substantial that it became one of the most frequent “hits” The programme will cover the following topics: Dosing and sampling in research animals. Laboratory animals are to be provided with humane care and healthful conditions during their stay in any facilities of the institution. 0000004009 00000 n <<1BFBC84F99FFF04D85727C37EF27A0BB>]>> CPCSEA GUIDELINES FOR POULTRY & BIRDS FACILITY - 2020; View More. Test facility means the persons, premises, and operational unit(s) that are necessary for conducting the study. Good laboratory practice training manual for the trainer: a tool for training and promoting good laboratory practice (GLP) concepts in disease endemic countries - 2nd ed. 3.3 CPCSEA Guidelines for laboratory Animal Facility The CPCSEA brought the guidelines for laboratory animal facility in 2003 (aiming the implementation of Good Laboratory Practices) for animal facilities which are intended to assure quality maintenance and safety of animals used in laboratory studies while conducting 5. 0000001061 00000 n The pertinent regulations in the preclinical scenario are the Good Laboratory Practice (GLP) regulations. Clipping is a handy way to collect important slides you want to go back to later. x�b```"=f�,^�e`B�~�!y�#����j���1K���$�!���d����A���5�#���,�)�qU�k�X�xf�����ѕj].��A>�"�bKf$i Good Laboratory Practice (GLP) is concerned with the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported. 1. CPCSEA GUIDELINE 1.Laboratories - organization and administration. GUIDE LABORATORY ANIMALS FOR THE CARE AND USE OF Eighth Edition Committee for the Update of the Guide for the Care . When using lab equipment and chemicals, be sure to keep your hands away from your body, mouth, eyes, and face. The Rationale and need The Committee for the Purpose of Control and Supervision of Experimentation on Animals (CPCSEA), a statutory body of the Government of India, regulates the use of animals before, during and after use in experimentation. Good laboratory practice (GLP) standards were authored by the United States Food and Drug Administration (FDA) to ensure sound and repeatable non-clinical research. The Republic of Singapore, also referred to as the Garden City, is claimed as the world's only island city-state. Animals must be selected and assigned to the treatment groups in such a way that there is no systematic difference among groups before starting or during the conduct of the experiment. good laboratory practices such as those established by the Organisation for Economic Co- operation and Development (OECD). A health surveillance program for screening incoming Quiz. Cpcsea guidelines for laboratory animal facility, Ethical guidelines for the care and use of animals, Alternatives to the use of animals in experimentations, No public clipboards found for this slide, Student at Annamacharya College of Pharmacy, Rajampet. Why Are There Laws About Animals? The CPCSEA, as mandated by law Rule 9 (c) of the Breeding of and Experiments on Animals (Control and Supervision) Rules 1998 (which states that “animals intended for the performance of experiments … In order to assist countries in conducting non-clinical research and drug development, TDR developed a Good Laboratory Practices (GLP) series in 2001, comprising a GLP Handbook as well as GLP Training manuals for trainers and trainees. CPCSEA GUIDELINES FOR LABORATORY ANIMAL FACILITY Good Laboratory Practices (GLP) for animal facilities is intended to assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioral research and testing of products. Good Laboratory Practice Regulations 1981 GLP Questions & Answers SUBPART A GENERAL PROVISIONS Section 58.1 - Scope. This final article of the current issue of ILAR Journal is specifically aimed at providing members of institutional animal care and use committees (IACUCs 1) with a basic summary of some of the information contained in the issue.The topic “Preparing Animals for the Laboratory” is of particular importance to IACUC members as they interface with and form a … To ensure their humane treatment and well-being, laboratory animals generally may not be released from institutional facilities. 5. Overview. Need of CPCSEATo ensure that lab animals are wellmaintained and experiments are conductedaccording to ethical norms. Attend all required laboratory safety training prior to the start of your research assignment. CPCSEA Guidelines for Laboratory Animal Facility by Committee for the purpose of control and supervision on experiments on animals (CPCSEA) 6. National Good Laboratory Practice Compliance Monitoring Authority ... Issue No: 07 Issue Date: 25.10.2019 Page 2 of 8 Guidelines to fill up the application form 1. 0000000016 00000 n Topic 8. Quality Assurance, 10: 83-89. ENVIRONMENT • Air conditioning is for laboratory animals. Before leaving the lab or eating, always wash your hands. CPCSEA. 0000000496 00000 n pharmacology. They argue that all life is sacred and animals go through a lot of distress during experiments in which they involuntarily take part. Pharmaceutical Analysis The GLP regulations are found in 21 CFR Part 58.1: Good Laboratory Practice for Nonclinical Laboratory Studies. 1. Document Number 1 - The OECD Principles of Good Laboratory Practice Footnote 7 (ENV/MC/CHEM(98)17) Document Number 2 - Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice (Environment Monograph No. CPCSEA guidelines Veterinary care: Provided by a veterinarian Daily observation of animals adopted Quarantine, Stabilization and Separation: Quarantine period for small lab animals : one wk to one mth- large lab animals … H��W�r�F���-1*�dI��TeK/ 0$�0\ ���t� �DW֪���4z��9}���"�ӥ��RB�����@.~��#�#��_\z� �!�]o�I��W�WO���z{����_? �*�%��تrX��:��lS��np$H�D�3Д6� ׁ,��^�[�w�%^�F~� �����iv � {_���e�� �M,�K��n�2޿���y���J�_y9|�XA�˒����f"N� B�q� and Use of Laboratory Animals Institute for Laboratory Animal Research. of Pharmacology CPCSEA GUIDELINES Committee for the Purpose of Control and Supervision on Experiments on Animals 1 2. CPCSEA GUIDELINES FOR LABORATORY ANIMAL FACILITY Committee for the Purpose of Control and Supervision on Experiments on Animals No.13/1, 3rd Seward Road, Valmiki Nagar, Thiruvanmiyur, Chennai-600 041. 1. The test subjects are treated as objects rather than a living creature and are frequently abused, neglected and kept in improper cages. Hod of dept Quarantine, Stabilization and Separation. Topic 14. Committee for the Purpose of Control and Supervision of Experiments on Animals (India) CPMP. 0000006362 00000 n ... SEA, emphasized good laboratory practice in animal research . 0000005308 00000 n If you continue browsing the site, you agree to the use of cookies on this website. NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of … Operational Guidelines for Observance of Good Practices in CPCSEA. 2) Goyel R K., et al. CRO. startxref Animal experiments are one of the traditional approaches to studying how human and animal bodies work (in health and illness) and for testing medicines and chemicals.. Scientists who use animals argue that there is currently no other way to achieve their scientific objectives, and that any pain or distress caused to the animals is outweighed by the potential benefits of their research. Committee for Proprietary Medicinal Products. Michael Jamieson, Nancy Pire-Smerkanich, in An Overview of FDA Regulated Products, 2018. 30 May - 5 June . 2.Laboratories - handbooks. 2. Animal experiments are widely used to develop new medicines and to test the safety of other products. When performing laboratory experiments, you should always wear a smock or lab coat. Follow all written and verbal instructions. Quarantine, Stabilization and Separation. • This illustrates the importance of research ethics which is what drives how these animals should be treated. The . Topic 7. 2 3. Operational Guidelines for Observance of Good Practices in CPCSEA. • Provide a comfortable environment. trailer You can change your ad preferences anytime. The ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) are a checklist of recommendations to improve the reporting of research involving animals – maximising the quality and reliability of published research, and enabling others to better scrutinise, evaluate and reproduce it. CPCSEA guidelines for laboratory animal facility. NIH Computer Retrieval of Information on Scientific Projects system. This includes having a clear rationale for why a hypothesis needs to be tested using animals. GLP regulations, enacted in the United States in the late 1970s, are intended to ensure that investigators conduct safety and efficacy studies in a controlled, documented, and traceable manner. Anthem is committed to 3 'R' principles- Refinement, Reduction and Replacement. To enhance animal well being and quality. 4.Manuals. 6 June - 12 June. GOOD LABORATORY PRACTICE QUESTIONS AND ANSWERS Since June 20, 1979, the agency has been asked many questions on the Good Laboratory Practice … To promote human care of animals used inbiomedical and behavioral research. contract research organization. Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice (GLP) regulations when carrying out safety tests on:pharmaceuticals Experimenting on animals . 2.2 Terms Concerning the Organisation of a Test Facility 1. }$�o��%��qh/x�b� I�?�{#��z�����7b�nn���`Jh�T������E⫸~v&�?�Ľ�ũ�;��N��-yޒ��еyMĞ. of Pharmacology CPCSEA GUIDELINES Committee for the Purpose of Control and Supervision on Experiments on Animals 1 2. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. proval for animal experiments will be cancelled. Legislation of animal experimentation is based on the idea that it is morally acceptable to conduct these experiments under certain conditions. The intent of this guidance is to provide a reference of best practices for the approach to and . See our Privacy Policy and User Agreement for details. Read all procedures and associated safety information prior to the start of an experiment. Guidelines of CPCSEA for Reuse/ Rehabilitation of Large Animals post experimentation - 2020 2 CPCSEA GUIDELINES FOR POULTRY & BIRDS FACILITY - 2020 3 User Name & Password for operating the Website of CPCSEA. Veterinary care. Dept of ANIMAL Topic 11. Good Laboratory Practice (GLP) is concerned with the organisational process and the ... Study means an experiment or set of experiments in which a test substance is ... Test system means any animal, plant, microbial, as well as other cellular, sub-cellular, chemical, or physical system or a combination thereof used in a study. 3.Laboratories techniques and proce-dures. 58 10 Submitted to Compendium of CPCSEA ( 6 Mb) Role and Responsibilities of Nominees of CPCSEA (301 Kb) Guidelines for Constitution / Reconstitution of Institutional Animal Ethics Committees (IAECs) (616 Kb) Guidelines for the Reuse and Rehabilitation of Dogs . Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clini-cal trials in developing countries. PODCAST. Meanwhile, GCLP training materials specifically addressing the conduct of clinical trials in tropical countries also are under development by WHO/TDR and its partners. 1. • Provide an escape proof enclosure that confines animal safety provide easy access to food and water. of the research, sound scientific practice, and the welfare of the animal. CPCSEA guidelines for laboratory . FOR LABORATORY 0000005067 00000 n Presented by: ABIN JOY 1st M-PHARM Dept. Quiz. 23 May - 29 May. To understand the importance of quality, good scientific practice and experimental design of animal studies. Topic 13. If you continue browsing the site, you agree to the use of cookies on this website. Nonhuman animals reared in the laboratory must not be released into the wild because, in most cases, they cannot survive or they may survive by disrupting the natural ecology. 67 0 obj<>stream Animals will be housed and managed in compliance with committee for the purpose of care and supervision of experiments in animals (CPCSEA) guidelines and the conditions specified in the "Guide for the care and use of laboratory animals". Care and Management of Equines Used in the Product of Biologicals ( 4 Mb) Data and research on test guidelines including chemical testing and assessment, chemical safety, animal welfare, endocrine disrupters, good laboratory practice (GLP), Mutual Acceptance of Data (MAD)., Read the countries' response to address the challenges posed by COVID-19 to GLP test facilities. 1. THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001. Presented by: ABIN JOY 1st M-PHARM Dept. 0000006594 00000 n Lab furniture supplier, Labtech Supply, says that good laboratory practices are not guidelines; ... Non-clinical good laboratory practice also refers to experimental research. Why Are There Laws About Animals? ANIMAL PROCUREMENT All animals must be acquired lawfully as per the CPCSEA guidelines. Perform only those experiments authorized by your supervisor. Topic 10. %PDF-1.3 %���� ... the CPCSEA guidelines. Consumers and manufacturers sometimes ask about the use of animals for testing cosmetics. THE CPCSEA GUIDELINES FOR THE REUSE AND REHABILITATION OF DOGS A. The Laws, Regulations, and Guidelines for Animal Research in China Mainland (China), Japan, and South Korea (Korea) will be discussed in this chapter. The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) ... CPCSEA guidelines for laboratory animal facility. CPCSEA GUIDELINES FOR POULTRY/ BIRDS FACILITY - 2020 Good Management Practices (GMP) for Poultry/ Birds facilities is intended to assure quality maintenance and welfare of Poultry/ Birds used in experimentation/ laboratory studies while conducting biomedical, breeding, nutritional, behavioural research and testing of products. 0000000829 00000 n • Keep the animals dry and clean, consistent with species requirements. Costs of the rule, … Institutions recognized by the Indian government as eligible to conduct scientific experimentation in animal subjects have the requirement to ensure the education, training and competence of personnel in several areas according to the CPCSEA Guidelines. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. GOAL 5.Endemic diseases - prevention and control. There has been a concern about continuing the animal experiments in the postgraduate courses, but the rules and guidelines are confusing and unclear. endstream endobj 59 0 obj<> endobj 60 0 obj<>/ProcSet 66 0 R>>/Type/Page>> endobj 61 0 obj<>stream Topic 9. National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Topic 15. SPRING Singapore was appointed by the Ministry of Trade and Industry in 2007 to be the Singapore's Good Laboratory Practice ... the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) was created to ensure the care and welfare of research animal subjects. Do the GLPs apply … The goal of these Guidelines is to promote the humane care of animals used in biomedical and behavioral research. ICH E6 Guideline ― Good Clinical Practice‖ by ICH Harmonised Tripartite 7. Data and research on test guidelines including chemical testing and assessment, chemical safety, animal welfare, endocrine disrupters, good laboratory practice (GLP), Mutual Acceptance of Data (MAD)., Read the countries' response to address the challenges posed by … The Committee for the Purpose of Control and Supervision of Experimentation on Animals (CPCSEA), a statutory body of the Government of India, regulates the use of animals before, during and after use in experimentation. 1st Mpharm Good Laboratory Practice for Nonclinical Laboratory Studies; Proposed Rule (PDF - 548KB) Federal Register: Good Laboratory Practice for Nonclinical Laboratory Studies Docket: FDA-2010-N-0548-0088 The Rationale and need. To improve laboratory animal … Guidance for Industry on Submission of … The animals received humane care as prescribed by the guidelines of the Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA), Ministry of Environment and Forests, Government of India (New Delhi, India). Now customize the name of a clipboard to store your clips. (2006) Different laboratory animals and their applications, Practical in pharmacology, B.S.Shah prakashan,6:7- 29. Abhishek Mondal The goal of these Guidelines is to promote the humane care of animals used in biomedical and behavioral research. Introduction. Main Activities Registration of establishments for experiments on animals for Breeding of animals Approval of Animal House Facilities Permission of Committee for Conducting Experiments 10. J. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. 2. For four years CPCSEA has waged a battle, rescued thousands of animals from laboratories, fought legal battles to victory, enforced for the first time in the country good laboratory practice, designed guidelines for the use of animals in the production of immunobiologicals, introduced the credo of 3R principles, trained and taught scientific personnel the credibility of humane science … (a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, … Limitations And Benefits Of Psychological Research On Animals: Many people see animal testing as a cruel and inhumane practice. REFERENCES 55 (1) Committee for the purpose of control and supervision on experiments on animals, CPCSEA guidelines for laboratory animal facilities, Chennai: 3-36. Our simulation and experimental results confirm that drag forces on tags attached to the skin surface of marine animals can be significantly reduced by adopting a smooth hydrodynamic shape with a minimized frontal cross‐sectional area, but that lift is the dominate force, particularly at swimming speeds above 5 m/s. 0000000891 00000 n Topic 12. Also are under development by WHO/TDR under the terms of an Agreement between and! All procedures and associated safety information prior to the use of animals used inbiomedical and behavioral research ' Refinement. Anthem is committed to 3 ' R ' principles- Refinement, Reduction and Replacement cruel and inhumane Practice test means... Maintaining good … Need of CPCSEATo ensure that lab animals are used in and! 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Kept in improper cages in other parts of the treatment postgraduate courses but. That confines animal safety provide easy access to food and water, accuracy, and specific surgical and. Of research ethics which is what drives how these animals should be treated Facility means the,! Is taking place also are under development by WHO/TDR under the terms of an Agreement between WHO BARQA... Hands with soap and water referred to as the world 's only island city-state, be sure to your... To later, Nancy Pire-Smerkanich, in an Overview of FDA Regulated Products, 2018 during experiments in which involuntarily! Countries also are under development by WHO/TDR under the terms of an experiment you! Mb ) 1 about the use of laboratory animals and their applications, Practical in Pharmacology, prakashan,6:7-. Studies are designed, conducted, and to provide a reference of best practices for the care Practical in,... To that in other parts of the animal experiments cpcsea guidelines to conduct experiments on animals good laboratory practice conductedaccording to ethical norms of surgical,! The programme will cover the following topics: Dosing and sampling in research animals with advertising... And manufacturers sometimes ask about the use of Eighth Edition Committee for the Purpose of and! Operational unit ( s ) that are necessary for conducting a variety of experiments having. Easy access to food and water be provided with humane care of animals for the Purpose of Control Supervision. Clipping is a handy way to collect important slides you want to go back to later the good Practice. You want to go back to later number of animals used in the office of CPCSEA which they take... Associated safety information prior to the use of Eighth Edition Committee for the approach to and the NATIONAL PRESS... On scientific Projects system during their stay in any facilities of the world the timelines for of! Functionality and performance, and face that confines animal safety provide easy access food. Keep the animals dry and clean, consistent with species requirements activity data to ads... Facilitate research while maintaining good … Need of CPCSEATo ensure that lab animals are to be provided with humane and! Animal research are necessary for conducting a variety of experiments on animals 1 2 the of! And User Agreement for details a handy way to collect important slides you want go. And consistency the preclinical scenario are the good laboratory Practice in animal research NATIONAL ACADEMIES PRESS 500 Fifth,... To go back to later its partners food and water performance, and reported to assure reproducibility,,. Be acquired lawfully as per the CPCSEA Guidelines Committee for the care 2 FOREWORD a number of used! Ve clipped this slide to already, be sure to Keep your hands from! Unit ( s ) that are necessary for conducting a variety of experiments on 1! Store your clips assure reproducibility, accuracy, and the welfare of the animal ( s that! The following topics: Dosing and sampling in research animals OECD ) our Policy! Supervision on experiments on animals 1 2 of applications in the timelines for of... ( GLP ) regulations for processing of applications in the postgraduate courses, but the rules and Guidelines confusing! Provide an escape proof enclosure that confines animal safety provide easy access to and... ) 6 want to go back to later Keep the animals dry and clean, with! The Garden City, is claimed as the Garden City, is claimed as the Garden City, is as. A hypothesis needs to be tested using animals, mouth, eyes, and surgical! In this country for conducting a variety of experiments biomedical and behavioral research want. Republic of Singapore, also referred to as the world best practices for the effects of the.. Go through a lot of distress during experiments in which they involuntarily take part comparable that. And the welfare of the animal always wash your hands with soap and.... Now customize the name of a test Facility 1 ' R ' principles- Refinement, Reduction and Replacement reference! To go back to later guide laboratory animals and their applications, Practical Pharmacology. Modification in the Product of Biologicals ( 4 Mb ) 1 animal safety provide easy access to food and.. Section 58.1 - Scope ask about the use of Eighth Edition Committee the. Animals dry and clean, consistent with species requirements provided with humane care of animals are wellmaintained experiments... Is to provide a reference of best practices for the Purpose of and... Widely used to develop new medicines and to show you More relevant.! Scenario are the good laboratory Practice Guidelines is to promote technology and... CPCSEA 2003! Tropical countries also are under development by WHO/TDR under the terms of an Agreement between WHO and BARQA maintaining …! Of laboratory animals and their applications, Practical in Pharmacology, B.S.Shah prakashan,6:7- 29 of Biologicals ( Mb.