Quality Systems

Palamur is committed to good professional
practices and compliance to applicable regulations

Animal Care Procedure

Palamur is already operating with large animal commercial production unit and strictly follows the national and international animal welfare practices. In addition to the above Palamur is actively involved along with NGO’s for animal welfare campaigns and advises its clients to use minimum number of animals for their product evaluation. Our expert scientist always work towards the 3Rs in animals usage.

Replacement: Methods that avoid or replace the use of animals.

Refinement: 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.

Reduction: Methods that minimize animal use and enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals, thereby reducing future use of animal

Palamur is already approved by CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals, Govt. Of India body) and AAALAC Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International accreditation shows our commitment for conducting studies in an ethical and humane manner.

The following practices are strictly followed by Palamur:

  • All the experiments are conducted in accordance with CPCSEA, (Committee for the Purpose of Control and Supervision of Experiments on Animals) a Governmental body managing ethical animal’s research.
  • The uses of small animals are governed through Institutional Animal Ethic Care (IAEC)
  • The use of large animals is governed through CPCSEA after recommendation from IAEC
  • Accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International
  • A team of veterinarians is appointed as Institutional Animals Welfare Officers, to ensure compliance of Institutional Animal Welfare policies.

Test Item Control Office(TICO)

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, crop protection products, and other chemicals.

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.

Archives

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 Palamue will dispose after obtaining the written approval from the sponsors.

Quality Assurance

Palamur complies with various national / international Quality systems such as OECD GLP, ISO, USFDA GLP (21 CFR Part 58 rev. 2009), and NABL. Palamur is operating with dedicated QA team Independently reporting to senior management. They ensure generation of appropriate SOPs, defining and monitoring audit observations, daily update to the management. They are responsible for Master Schedule Index, Audit Master and track the TICO and Archive matters.

The teams cross audit each other for facilities, systems and processes. Study audit reviews the study protocols, audits live phases, raw data, draft and final reports. System audit includes the facility audits and document control. Each scientist at Palamur is trained & regularly monitored for keeping abreast of GLP compliance.

Quality Systems

System Audit

  • Internal quality & systems audit of TICO, archives, vivarium, research facilities and utilities
  • Monitoring of on-time maintenance, calibration, & validation of instruments.
  • Revision of SOPs/document control

Study audit

  • Review of study protocols
  • Process based audits
  • Audit of live studies at various phases
  • Audit of raw data, draft & final reports
  • Maintenance/updating of master schedule

Project Management

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.

Data Security and Confidentiality

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.