Certifications
and Confidentiality
Test Item Control Office
Effective blend of services
As the most preferred animal testing facility in India with species ranging from Rodents, Dogs, Minipigs (also conventional pigs), Sheep, etc., we are following the CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals, Govt. Of India body), FELASA (Federation of European Laboratory Animal Association) and AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care) practises for conducting studies in an ethical and humane manner.
We strictly follow the global 3R Guiding Principles (Replacement, Refinement and Reduction) to underpin the humane use of animals in scientific research. However, PBS has committed to one step ahead and following the 4th R that is Rehabilitation.
We use the techniques that do not use living animals and encompass In vitro & In silico (computer based programs) approaches and any other methodologies that eliminate the use of the living animal, e.g., structure–activity relationships.
Improvements to scientific procedures and husbandry that minimise actual or potential pain, suffering, distress or lasting harm, and/or improve animal welfare in situations where the use of animals is unavoidable. Refinement also comprises the use of species lower on the phylogenetic scale. Thus, replacing a dog with a mouse is a refinement technique.
The concepts of Reduction, decreasing the number of animals necessary in any protocol, is desirable, but the numbers should not be so low that the experiment is compromised, thus to obtain valid statistical compliant results is pivotal while reducing the number of animals in any protocol.
Our scientists have a moral responsibility to the animals after using them in the experiment, we care about the animals after procedure and rehabilitate them after certain period which is also a mandate process as per the legal requirement of CPCSEA.
Palamur is operating with well established Archives located in second floor of the test facility to withstand flood/fire.
We have dedicated areas for dry and wet archives and the whole facility is controlled by access log systems.
Archived data is maintained by a dedicated indexing system which can trace the archive records in no time. Currently Palamur retains all the documents and specimens for 9 years and then returning to the sponsors. After the 9 year archiving period, study sponsors wish to retain some more time will be allowed.
In case sponsors wish to destroy the documents/specimens Palamur will dispose after obtaining the written approval from the sponsors.
Palamur is operating state of art Test Item Control Office ensures safe receipt of the test item, provides a unique code for each item, sponsors, maintains its mass balance and issue log, and holds the same in environmentally controlled storage till usage, expiry and disposal Palamur TICO facility has discrete, well separated areas to receive and store different types of products, such as Pharmaceuticals, Agrochemical and other chemicals products to ensure elimination of contamination.
The TICO facility has well isolated zones for handling Pharmaceuticals, Crop protection products, and other chemicals to ensure elimination of contamination
possibilities. They are also responsible for guiding the user / scientists about the hazards involved in handling a given test chemical.
We have separate Test Item Control Offices for Pharma and non-pharma products. All the test items are stored under suitable conditions based on their stability. The test items are handed over to the study director with guidance in respect of their stability to air and light.
Palamur Biosciences complies with various national/International Quality systems such as OECD GLP, US FDA GLP (21 CFR part 58) and others. At Palamur Biosciences test facility, Quality Assurance Unit (QAU) is independent of study conduct and directly responsible to the senior management. With the help of QAU, test facility management is ensuring the functioning of the organization in accordance with the principles of GLP. QAU functions as per the established quality procedures.QAU plan, schedule, perform, document and report inspections timely. QAU write their own department SOPs and review all other department SOPs.
QAU conducts Study-based, Process and Facility-based inspections. In the study based inspection, QA used to conduct study plan audit, in life phase inspection, raw data and Report audit. Facility based inspections are independent of the studies and conducted to monitor the general facilities and activities within a laboratory. Process based inspections are conducted to monitor the common procedures or processes of repetitive nature and are performed on random basis. QAU conducts vendor/supplier/subcontract audits as and when required.
Each QA auditor at PBS is trained & regularly monitors the GLP compliance.
Palamur is having dedicated efficient project management practices and proactive customer centric account management, Palamur Biosciences is fully geared up to provide an effective blend of services to enable accelerated study start dates, high quality study execution and regulatory compliance for product development.
Industry best practices for I.T and data management are institutionalized, complying with data security and confidentiality, including audit trail. Confidentiality of study data from project initiation through to project completion is maintained diligently with advanced coding procedures. A fireproof archival facility is designed for efficient retrieval of dry and wet artefacts during audit and to withstand any force majeure as per prescribed standards.
Palamur Biosciences Private Limited is a full service preclinical contract research organization operating at sub urban of Hyderabad city, Mahabubnagar close to Hyderabad international airport, Telangana State, India.
