State-of-the-art GLP Standard
Invivo Laboratory for Drug Discovery and Development(Animal House)
Overview
Our state-of-the-art GLP Standard in vivo Laboratory (Animal House) was established at CSIR-IIIM, Jammu for the purpose of conducting preclinical (Animal) or nonclinical studies for the Drug Discovery and Drug development on GLP Mode, which is requires for the Investigational New Drug (IND) application to the regulatory agencies. This is well equipped, high standard barrier facility having Ground floor, first floor and Service floor to provided sufficient space for the separation of activities (total covered area is 3304 sq.m.) and capable to conduct number of parallel animal studies. It fulfill the requirements of clean room concept and standards of international and national regulatory agency GLP, FDA, OECD,CPCSEA, AAALAC, and DCGI.
Our aim to facilitate therapeutic area specific animal models for drug discovery for various disease like cancer, Sickle cell Anemia, Pain, inflammation, Arthritic, Alzheimer’s etc
The Animal House (AH) project is the backbone of research activities of Drug Discovery of Indian Institute of Integrative Medicine (IIIM). It breeds, maintain and provides various species and strains of quality animals to researchers of Institute. Annually, around 25,000 rodents are produced and reared in the Animal House, out of which around 20,000 rodents are put to actual research use by scientists. The AH has its own institutional Animal Ethics Committee constituted specifically to address scientific and ethical considerations of animal use for research, and this has been in existence since 1998. The AH is also registered with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment and Forests, Government of India for breeding and conducting experiment on small animals.
The chief mandate of the AH is to breed and maintain different strains of mice, rats, guinea pigs and rabbits, and supply them upon request to institutional researchers. Surplus animals supplied on request to Govt. & Non-Govt. organizations registered with CPCSEA.
Main Features
- State of the art facility for the purpose of conducting preclinical (Animal) studies on GLP Mode. This is well equipped high barrier facility and it maintain separation of Activates as per compliance of FDA GLP 21CFR PART 58 & 21 CFR Part 11 for equipments etc. Compliance as per GLP, OECD, FDA etc. CPCSEA, AAALAC etc.
- Aims to strengthen in-house IND Enabling studies for Drug Development
- Aim to facilitate therapeutic area specific animal models for drug discovery(cancer, Sickle cell Anemia, Pain, inflammation, Arthritic, Alzheimer’s etc)
- Clean room concept followed
- Sufficient space for number of parallel studies at a time .
- Animal holding Capacity is aprox.20000mice/ 9000Rats in IVC’s.
- Covered area: 3304 sq.m. with G+1+ Service floor.
The Facility Breeds and Supplies the Following Species and Strains of Animals
Species | Strains | Status |
Mouse | Swiss mice | Outbred |
BALB/c mice | Inbred | |
C57BL/6J Mice | -do- | |
DBA/2 Mice | -do- | |
DBA-1 Mice | -do- | |
CDF1 Mice | F1 Hybrid | |
Rat | Wistar | Outbred |
Guinea Pig | English, albino | -do- |
Rabbit | New Zealand White | -do- |
GLP Standard In vivo Laboratory (Animal House)
GLP Standard In vivo Laboratory will be functional very soon to conduct regulatory studies for drug Development as per FDA, ICH, OECD, DCGI and AAALAC, CPCSEA for animal experimentation.
GLP Standard In vivo Laboratory
- For the purpose of Drug Development under strict GLP guidelines
- As per Regulatory and FDA requirements
- In Compliance of for GLP (National GLP Programme & OECD GLP) ,ICH,FDA,DCGI and other Accreditations (i.e., AAALAC)
- To follow CPCSEA guidelines
- To produce specific pathogen free (SPF) to germ free laboratory animals in this in vivo laboratory (Animal house)
Capacity of Animal Breeding/Holding Rooms
- Total number of animal rooms: 24
- Number of animal breeding/holding rooms: 12
- Number of Quarantine Rooms: 2
- Each room having capacity to hold two double sided IVC racks (rat/mice) and each rack can hold 160 cages for mice and 144 cages for rats
- Capacity of each room: 320/ 288 cages for mice and rats respectively
Facility Available
Animal Breeding /Holding Rooms (12 Nos.) | 3100 x 5070 mm/3135 x 7470 mm |
In vivo Toxicology Laboratory (4Nos.): | 3100 x 5070 mm |
Experimental Laboratory (2Nos.) : | 3135 x 7470 mm |
Clean Cage Store: | 3248 x 7470 mm |
Clinical Pathology Laboratory: | 3100 x 5070 mm |
Necropsy Lab | 3520 x 4470 mm |
Animal Holding Room For Necropsy | 2020 x 2400 mm |
Central Nervous System with sound proof room | 4435 x 7290 mm |
Cardiovascular System with Animal Room: | 3193 x 5125 mm |
G.I. with Animal Room: | 3193 x 5125 mm |
Respiratory with Animal Room : | 3125 x 4805 mm |
Histopathology: | 6500 x 7520 mm |
Clinical Pathology: | 3100 x 5070 mm |
HERG & APD: | 6270 x 4735 mm |
Genotoxicology: | 4470 x 4735 mm |
Tissue Culture (2Nos.): | 4470 x 4735 mm |
AMES Mutagenecity: | 4135 x 5451 mm |
Construction
No. of Floors | G+1+Service Floor |
Ground Floor Covered area | 1378 sq.m |
First floor covered area | 1372 sq.m |
Service floor covered area | 554 sq.m |
Total covered area | 3304 sq.m |
Start of Construction | 12.12.2012 |
Completion period | 11.07.2014 |
Service/Utility
- Service floor for housing Air Handling Units of the HVAC System
- Exhaust fans/Compressors for HVAC System
- Equipments for Solar Water Heating System, RO Plant, etc
Provisions in HVAC System
- Centralized Air Conditioning for Clean areas in Ground Floor & First Floor with 250 TR capacity
- Split/Window ACs for Management/Office Area
- 100% backup with provision of standbys in all animal rooms and equipments (supply as well as exhaust)
- Proper distribution of air changes as per requirements of specific rooms
- Exclusive exhaust system for IVCs
Provisions in Electrical System
- Sub-station with 630 KVA transformer
- 100% power backup with 500 KVA DG Set
- UPS supply for LAN network & Pass boxes
- Passenger Lift of 8 persons-1 No., Goods cum passenger lift of 1000kg -2Nos ( 1 No. Clean Lift and 1 No. Dirty Lift)
- LAN Network, Access Control System, Video Conference System, Telephone Network, CCTV
Provisions in Fire Fighting & Alarm System
- Underground Water Tank with Pump room, pumps with 50m head capacity, Fire tank at terrace
- Internal & External Fire hydrants, Fire Hydrant Chambers
- Fire Extinguishers & Smoke Detectors inside the building
Provisions in PHE
- Treated water supply from Water Treatment plant (1500 lit per hr.) & RO Plant (400 lit per hr.)
- Solar Water Heating System for 1500 lit per day
- ETP of 10 KLD & Softener for HVAC 1 No.
- Rain Water Harvesting System
Proposed designed of Animal Room
IIIM supported INVIVO Studies of various other Institutions in India by providing Rodents (Animals) during last five years.
Sr.No. | Name of institute |
1
|
PGIMER, Chandigarh |
2
|
CSIR-IGIB, New Delhi |
3
|
ICAR-National Dairy Research Institute(NDRI, Karnal) |
4
|
ICAR-National institute of high security animal Disease(NIHSAD),Bhopal |
5
|
CSIR-IHBT, Palampur |
6
|
GNDU, Amritsar |
7
|
Regional Research Institute of Unani Medicine, Srinagar |
8
|
University of Kashmir |
9
|
Institute of Animal health & Biological Product,Zakura,Srinagar |
10
|
Institute of Animal health & Biological Product,R.S Pura,jammu. |
11
|
Dept. Of Pharmacology and Therapeutics,Govt. Medical college, Jammu |
12
|
Dept of Anatomy, Govt. Medical college, Jammu |
13
|
Department of Pharma,biochem,parasitology of Veterinary college, SKUAST, Jammu |
14
|
Department of Pharmacology and toxicology,Veterinary college,Palampur(H.P) |
15
|
ISF College of pharmacy, Moga,Punjab |
16
|
ICAR-IVRI,Palampur |
17
|
Dept. of Biosciences, H.P.U. Shimla |