FACILITIES

Animal Research Facility (ARF)

Animal Research Facility (ARF) at PRADO The facility is designed in compliance with CPCSEA, GLP and AAALAC regulations. The total spread over area of ARF is ~4000 sq. ft. ARF is Registered with Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA ), Under the Ministry of Environment and Forests Government of INDIA having the Reg No. 1723/PO/RcBiBt/13/CPCSEA for breeding, trade and conducting experiment on small laboratory animals.

The Institutional Animal Ethics Committee (IAEC ) approves and monitors all animal experimentations. Institutional Biosafety committee (IBSC ) is also in place which regulates handling genetically modified organisms and recombinant DNA (rDNA) material for research and production.


ARF is maintained under the controlled conditions for temperature, humidity, air pressure, air changes, light intensity and sound intensity as per regulatory requirements. The 12 hours light and 12 hours dark cycles are maintained by automatic controller. The Utility areas contains areas for washing, autoclaving, storage of feed, bedding material and general storage and quarantine room.Sufficient number of rooms or areas to assure isolation of individual projects.

All activities of the Animal Facility are carried out as per standard operating procedures (SOPs). Standard animal husbandry and veterinary care by experienced Veterinary staff. PRADO implements principles of 'Three Rs' Replacement, Reduction, Refinement.

Pathology

At PRADO, we have developed separate clinical pathology, necropsy and histopathology laboratories. Clinical Pathology Lab is equipped with various auto analyzers including hematology, clinical chemistry and urine analyzers and Histopathology lab is engaged in performing various processes involved in histopathology slide preparation.A spacious necropsy room is available for conduct of gross pathology examination, organ weights and organ collection.Pathology department supports various preclinical experiments by conducting the blood collection, plasma separation and performing various hematology and clinical chemistry and urine analysis. Qualified Veterinary Pathologists monitor all activities and evaluate histopathology slides, prepares report. It also have capabilities to perform immunohistochemistry, special staining as per clients requirements.Histopathology department also works as a stand-alone and supports external projects independently.

Quality Assurance Unit (QAU)

At PRADO, Quality Assurance Unit (QAU) is separate department, established in accordance with the requirements of OECD principles of GLP. QAU conducts, study based, facility based and process-based inspections, as per the standard operating procedures (SOPs). QAU also reviews all SOPs, study plans, reports, master schedule and also conducts vendor qualification. Thus, QAU at PRADO works as "A defined system, including personnel who are independent of studies being conducted and designed to assure test facility management of compliance with the principles of GLP".

Test Item Control Office - TICO

For receipt, Handling, storage and dispensing of Test items, Reference Items and control items, PRADO has separate Test Item Control Office (TICO). All the records of receipt, utilization and discard of the test items are maintained as per SOPs and GLP requirements. There is separate room for formulation preparation and storage.

Archives

Archives at PRADO is established in accordance with OECD principles of GLP. They are suitably designed and constructed to accommodate archived records and material. There are separate Dry and Wet Archives to store the facility and study related data. All the soft data is stored securely in separate folder maintained on server. Archives are physically secured to prevent unauthorised entry to Archives. Storage conditions of archives are maintained to preserve the quality and integrity of retained records from untimely deterioration and risk of fire. The indexing system is followed for the proper storage and retrieval of materials is facilitated.Movement of material in and out of the archives will be properly controlled and documented.

Environment, Health and Safety

PRADO understands its Corporate- social responsibility, towards this PRADO has established solar system to save the electricity and making use of natural renewable energy. For processing of facility waste, bio-digester system has been in place. Fire alarms and smoke detectors are placed at various points; there is routine training towards fire-fighting and mock drills for emergency evacuation. All the employees are subjected for annual health check-up.There is provision for appropriate segregation, collection, storage and transportation for disposal of bio waste. Contract with pollution control board approved vendor is in place for collection and incineration of bio waste.

In vitro Facilities

PRADO, has developed separate in vitro facilities for conducting the genotoxicity studies, in vitro biocompatibility studies including cytotoxicity assays. We are in process of getting the GLP certification for conduct of various genotoxicity studies and ISO certification for conduct of various biocompatibility studies.

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