Cpcsea ppt

M. kavya nainita
Mpharmacy I YEAR

1. CPCSEA Guidelines A Seminar presented as a part of I Year M. Pharm I semester Requirement ACY 2019 – 20 By M. Kavya Nainita Regd. No. 19L81S0406 Pharmaceutical Quality Assurance, Raghavendra Institute of Pharmaceutical Education & Research (AUTONOMOUS), Anantapuramu. 06-01-2020 1

2. CONTENTS CPCSEA - Definition Goals Objective Committee members Forms CPCSEA Annexures Animal procurement References 06-01-2020 2 PHARMACEUTICAL QUALITY ASSURANCE RIPER

3. Introduction C ommittee for the P urpose of C ontrol and S upervision of E xperiments on A nimals. It is statutory committee. Established under Section 15 of the prevention of cruelty to animals act 1960 . Committee was reconstituted on 17 February, 2016. 06-01-2020 3 PHARMACEUTICAL QUALITY ASSURANCE RIPER

4. CPCSEA Definition Committee for the purpose of control and supervision of experiments on animals. It is statutory body formed by the act of the Indian Parliament under the Prevention of Cruelty to Animals Act, 1960. The secretariat of CPCSEA has published its guidelines, to ensure humane and ethical treatment of animals, while carrying out legitimate scientific research. It was formed in 1964 . Headquarters is at Ballabhgarh of Faridabad district in Haryana. 06-01-2020 4 PHARMACEUTICAL QUALITY ASSURANCE RIPER

5. GOAL To promote the humane care of animals used in research. To provide specifications that will enhance animals well being and quality of research . Effective functioning of IAEC. To provide guideline for: Housing, care, breeding and maintenance. Source of experimental animals Acceptable experimental procedures for anaesthesia and euthanasia . OBJECTIVE 06-01-2020 5 PHARMACEUTICAL QUALITY ASSURANCE RIPER

6. COMMITTEE MEMBERS It is composed of Members of the scientific community Regulatory authorities Animal activists The committee has 20 Experts and 3 Official Members . 06-01-2020 6 PHARMACEUTICAL QUALITY ASSURANCE RIPER

7. 1 Special Secretary / Additional Secretary, In-charge of Animal Welfare, Government of India, Ministry of Environment, Forest & Climate Change, New Delhi Chairman 2 Joint Secretary (Animal Welfare), Ministry of Environment, Forest & Climate Change, New Delhi Vice Chairman 3 Representative from Drug Controller General of India (DCGI), New Delhi Member 4 Representative from Medical Council of India (MCI), New Delhi Member 5 Representative from Veterinary Council of India (VCI), New Delhi Member 06-01-2020 7 PHARMACEUTICAL QUALITY ASSURANCE RIPER

8. 6 Representative from Pharmacy Council of India (PCI), New Delhi Member 7 Representative from University Grants Commission (UGC), New Delhi Member 8 Representative from Animal Welfare Board of India (AWBI), Ballabhgarh Member 9 Dr. Suresh Pothani, Representative ICMR, Director In Charge & Scientist “G” ICMR – National Animal Resource Facility for Biomedical Research, Hyderabad Member 10 Prof. Asmita Gajbhiye, Professor & Head, Dept of Pharmaceutical Sciences, Dr. H.S. Gour Vishwavidyalaya, Sagar Member 06-01-2020 8 PHARMACEUTICAL QUALITY ASSURANCE RIPER

9. 11 Prof. Alok Dhawan, Director, CSIR – Indian Institute of Toxicology Research, Lucknow Member 12 Dr. Anurag Agrawal, Director, CSIR – Institute of Genomics & Integrative Biology, New Delhi Member 13 Dr. Ram Vishwakarma, Director, CSIR – Indian Institute of Integrative Medicine, Jammu Member 14 Dr. Pardeep Kumar Yadav, Senior Veterinary Officer, All India Institute of Medical Science, New Delhi Member 15 Dr. S.G. Ramachandra, Chief Research Scientist, Central Animal Facility, Indian Institute of Science, Bangalore Member 06-01-2020 9 PHARMACEUTICAL QUALITY ASSURANCE RIPER

10. 16 Dr. Subeer S. Majumdar, Director, National Institute of Animal Biotechnology, Hyderabad Member 17 Prof. Dr. M. Ramachandra Mohan, Professor, Dept of Zoology, Bangalore University Member 18 Prof. Madan Mohan Chaturvedi, Professor and Head, Department of Zoology, University of Delhi, New Delhi Member 19 Prof. Aditya Kumar, Director, SKS Institute, Mathura Member 20 Director/Deputy Secretary (Animal Welfare) Ministry of Environment, Forests & Climate Change, New Delhi. Member 06-01-2020 10 PHARMACEUTICAL QUALITY ASSURANCE RIPER

11. Forms Forms Purpose FORM A [As per rule 5(a)] Application for Registration with CPCSEA Form B (per rule 8(a) Submission of Research Protocol (s) on Large Animals Form C Record of Animals bred / acquired Form D Record of Animals Acquired and Experiments performed FORM- E Record of animals sold 06-01-2020 11 PHARMACEUTICAL QUALITY ASSURANCE RIPER

12. IAEC Institutional animal ethical committee. Definition: Body comprising of a group of persons recognized and registered by the CPCSA. Function: Review and approve all types of protocols for research involving animal experimentation. Obtain the periodic reports on research development and shall ensure visit to animal house facility and laboratory. 06-01-2020 12 PHARMACEUTICAL QUALITY ASSURANCE RIPER

13. Ministry of Environment and Forests (Animal Welfare) CPCSEA IAEC IBSC/IBC Institutional Bio Safety Committee 06-01-2020 13 PHARMACEUTICAL QUALITY ASSURANCE RIPER

14. Role of CPCSEA is to monitor animal. Experiments through ethics committees set up in institutions (IAEC). IAEC scrutinize all project proposals for experimentation on animals. For small animals- give the final approval For large animals-make its recommendation to SCL (Sub-Committee on Large Animals) 06-01-2020 14 PHARMACEUTICAL QUALITY ASSURANCE RIPER

15. Qualification B. V. Sc M.Sc. (Zoology/ Animal Sciences/ Animal Biotechnology) M.Sc. / MTech (Life Sciences, Biological Sciences/ Biochemistry/ Biotechnology/ Biomedical Engineering) with experience in animal handling and animal research. M. Pharm with experience in animal handling and animal research. MD/ MS with research experience in laboratory animal handling. 06-01-2020 15 PHARMACEUTICAL QUALITY ASSURANCE RIPER

16. Age limit: 65 years . Duration: 5 years . Inspection report of animal house with photographs by IAEC members is required to be sent once in a calendar year. If action is required, the facility must provide within 30 days. 06-01-2020 16 PHARMACEUTICAL QUALITY ASSURANCE RIPER

17. Veterinary care Adequate veterinary care must be provided and is the responsibility of a veterinarian or a person who has training or experience in laboratory animal sciences and medicine. Observed regularly for sign of illness, injury or abnormal behaviour. Contagious disease – isolated from healthy animal. 06-01-2020 17 PHARMACEUTICAL QUALITY ASSURANCE RIPER

18. Surveillance, Diagnosis, Treatment and Control of disease ( Annexure 1 and 2 ) All animals should be observed for signs of illness, injury or abnormal behaviour by animal house staff. Unexpected deaths and signs of illness, distress or other deviations from normal health conditions in animals. 06-01-2020 18 PHARMACEUTICAL QUALITY ASSURANCE RIPER

19. Physical Relationship of Animal Facilities to Laboratories (Annexure-3) Separation of animal facilities from personnel areas such as offices, conference rooms, and other laboratories. Located away from dust, smoke, noise, wild rodents, insects and birds. Animal rooms should occupy 50-60% of constructed area. 06-01-2020 19 PHARMACEUTICAL QUALITY ASSURANCE RIPER

20. Transport of laboratory animals (Annexure – 4) Mouse Rat Hamster Guinea pig Rabbit Cat Dog Monkey Max.no Of animals/ cage 25 25 25 12 2 1 or 2 1 or 2 1 Material used in transport box Metal cardboard, synthetic material metal metal Bamboo/ wood/metal Space/ animal (cm²) Minimum height of box (cm) 20-25 12 80-100 14 80-100 12 160-180 15 1000-1200 30 1400-1500 40 3000 50 2000-4000 48 06-01-2020 20 PHARMACEUTICAL QUALITY ASSURANCE RIPER

21. 06-01-2020 21 PHARMACEUTICAL QUALITY ASSURANCE RIPER

22. Anaesthesia (Annexure-5) Sedatives, analgesics, anaesthetics should be used to control pain or distress under experiment. Before using anaesthetics the animal is prepared for anaesthesia by overnight fasting and using pre-anaesthetics ( scopolamine, atropine, diazepam, etc .) The animal should remain under veterinary care till it completely recovers from anaesthesia and postoperative stress. Narcosis Relaxation Analgesia 06-01-2020 22 PHARMACEUTICAL QUALITY ASSURANCE RIPER

23. Euthanasia (Annexure-6) Death without causing anxiety, pain or distress with minimum time lag phase. Done when an animal required to be sacrificed or termination of an experiment or otherwise for ethical reasons. Tranquilizers have to be administered to larger species such as monkeys, dogs and cats before an euthanasia procedure. 06-01-2020 23 PHARMACEUTICAL QUALITY ASSURANCE RIPER

24. Animal care and Technical Personnel (Annexure-7) Animal care programs On-the-job training Trained person in laboratory animal science. Protective clothing (face masks, head covers, aprons, gloves, gumboots, other footwear, etc.) 06-01-2020 24 PHARMACEUTICAL QUALITY ASSURANCE RIPER

25. Animal Experimentation Involving Hazardous Agents (Annexure-8) Policies governing experimentation with hazardous agents. Examine the proposal on animal experiments involving hazardous agents. IBSC members are knowledgeable about hazardous agents are in place in most of the higher-level education, research institutes and in many pharmaceutical industries for taking care of safety issues. 06-01-2020 25 PHARMACEUTICAL QUALITY ASSURANCE RIPER

26. Animal procurement All animals must be acquired lawfully as per the CPCSEA guidelines. A health surveillance program for screening incoming animals should be carried out to assess animal quality. Each consignment of animals should be inspected for compliance with procurement specifications. 06-01-2020 26 PHARMACEUTICAL QUALITY ASSURANCE RIPER

27. Quarantine Definition : Separation of newly received animals until the health and possibly the microbial status of newly received animal have been determine. An effective quarantine minimizes the chance for introduction of pathogens into an established colony. Quarantine period : small lab animals- 1 week to 1 month. large lab animal – 6weeks . 06-01-2020 27 PHARMACEUTICAL QUALITY ASSURANCE RIPER

28. Experimental area Experiments should be carried out in a separate area away from the place where they are housed. Separate functional areas for: surgical support Treatment of animals Post operative and intensive care 06-01-2020 28 PHARMACEUTICAL QUALITY ASSURANCE RIPER

29. Stabilization and Separation Physiologic, psychological and nutritional stabilization should be given before their use. Separation is needed to prevent interspecies diseases transmission and to eliminate anxiety and possible physiological and behavioural changes due to interspecies conflict. To prevent anxiety and behavioural changes. 06-01-2020 29 PHARMACEUTICAL QUALITY ASSURANCE RIPER

30. Physical facilities Building materials Durable, moisture – proof, fire resistant and pest resistant. corridors Movement of personnel and equipment Animal room doors Fit properly, no rust Exterior windows Not recommended floors Smooth, moisture proof, non absorbent, skid proof floors drains Proper drainage, floors should be sloped Storage areas For feed, bedding, cages Temperature and humidity Between 18-29 °C and 30-70 % ventilation Designed with 12-15 air cycles / hour Power and lighting Fluorescent lights noise control Noise free environment Concrete walls are more effective. 06-01-2020 30 PHARMACEUTICAL QUALITY ASSURANCE RIPER

31. Animal husbandry Housing system : Freedom of movement, normal postural adjustments. Comfortable environment Easy access to food and water Adequate ventilation 06-01-2020 31 PHARMACEUTICAL QUALITY ASSURANCE RIPER

32. Food and water Feed should contain Feed should not contain Moisture Insecticides, hormones, antibiotics, fumigants or toxicants Crude fibre, protein, fat Heavy metals Essential bits, minerals, carbohydrates Palatable Non-contaminated Nutritionally adequate Fresh Uncontaminated drinking water 06-01-2020 32 PHARMACEUTICAL QUALITY ASSURANCE RIPER

33. Bedding Adsorbent, free from toxic chemicals. Should be removed and replaced periodically with fresh materials. Ideal to change the bedding twice in a week. Newly delivered pups should be provided wherever needed. (paper, cotton, etc.) 06-01-2020 33 PHARMACEUTICAL QUALITY ASSURANCE RIPER

34. Transgenic animals Transgenic animals are those animals, into whose germs line foreign genes have been engineered. Used for study of biological functions of specific genes. Knockout animals are those specific genes have been disrupted leading to loss of function. Maintained in clean room environment or in animal isolators. 06-01-2020 34 PHARMACEUTICAL QUALITY ASSURANCE RIPER

35. Waste disposal Removed regularly and frequently. Disposed in a safe and sanitary manner. Preferred method – Incineration (thermal treatment – waste materials converts waste into ash, flue gas and heat). Waste cans containing animal tissue, carcasses and hazardous wastes – leak proof. Cold storage might be necessary to prevent decomposition of biological wastes. 06-01-2020 35 PHARMACEUTICAL QUALITY ASSURANCE RIPER

36. Emergency, Weekend And Holiday Care If any emergency, institutional security personnel and fire or police officials should be able to reach responsible persons for the animals. Emergency veterinary care. Posting emergency procedures, names, or telephone numbers in animals facilities in security department. 06-01-2020 36 PHARMACEUTICAL QUALITY ASSURANCE RIPER

37. Multiple surgical procedures on single animal No animal should be used for experimentation for more than 3 years unless adequate justification is provided. 06-01-2020 37 PHARMACEUTICAL QUALITY ASSURANCE RIPER

38. Breeding and Genetics The breeding stock must be procured from CPCSEA registered breeders or suppliers ensuring that genetic makeup and health status of animal is known. 06-01-2020 38 PHARMACEUTICAL QUALITY ASSURANCE RIPER

39. Record keeping Staff record- both technical and non-technical. Health record of staff animals. All SOP’s relevant to the animals. Breeding, stock, purchase and sales records. Records of experiments conducted with the number of animals used. Death record Clinical record of sick animals. Training record of sick animals Training record of staff involved. 06-01-2020 39 PHARMACEUTICAL QUALITY ASSURANCE RIPER

40. Standard operating procedures Name of author Title of sop Date of preparation Reference of previous SOP Objectives Detailed information of instruments used in animal methodology.(Model no., Serial no.) Normal value of all parameters Hazard identification and risk assessment. 06-01-2020 40 PHARMACEUTICAL QUALITY ASSURANCE RIPER

41. References CPCSEA.nic.in Appendix I of the New Zealand “Good Practice Guide for the Use of Animals in Research, Testing and Teaching” entitled “Pain: Some Concepts and Definitions”. Derelanko MJ. The toxicologist's pocket handbook. CRC Press; 2017 Nov 6. Olfert ED, Cross BM, McWilliam AA, editors. Guide to the care and use of experimental animals. Ottawa: Canadian Council on Animal Care; 1993. 06-01-2020 41 PHARMACEUTICAL QUALITY ASSURANCE RIPER

42. I'm so proud ! All of my kids are going into research. 06-01-2020 42 PHARMACEUTICAL QUALITY ASSURANCE RIPER