OECD-GLP Compliant CRO

                                  "Quality is not an act, it is a habit"- Aristotle

Contract Research Organizations (CRO) are meant to provide services to the industries related to Biotechnology, Agrochemicals, and Pharmaceutical products and at times for Medical devices too. Usually, CROs are divided into drug discovery, preclinical, clinical, and laboratory services out of which most of them are related to safety studies. In the current competitive environment of the drug development process, CROs can play a crucial role to reduce costs for product development and save time as well. Eventually, all the generated data must submit somewhere which we term as regulatory agencies for the final product approval. Harmonization plays an important role in the acceptance of this data which is governed by following related policies and guidelines precisely, by Good Laboratory Practices (GLP) published by authorities like the Organization for Economic Co-operation and Development (OECD) and the International Conference of Harmonization (ICH). Following the GLP compliance automatically stamps that the generated data during non-clinical studies are of good quality.

The principles of GLP are to ensure safety, superior quality, and trust of drugs in the practice of non-clinical and laboratory testing where studies are planned, performed, monitored, recorded, and reported. In India, National GLP Compliance Monitoring Authority (NGCMA) certifies GLP Compliance to CROs. After the Mutual Acceptance of Data (MAD) agreement with the OECD in 2011, India is developing as an excellent platform for the conduction of preclinical toxicity studies which is a mandate by regulatory authorities, fulfilled meticulously by CROs having GLP-certified laboratories. GLP-certified labs have traceability of GLP study data in terms that the test data is reliable, repeatable, and auditable. The work of the OECD related to chemical safety is carried out in the Environmental Health and Safety Division which assesses other uses relating to the protection of man and the environment.

CROs with GLP certification are synonymous with a quality system that delivers quality results. A quality system (OECD) comprises four major pillars that include Personnel, Facility, Documents, and Test or Control items.

OECD GLP Compliant CROs perform the preclinical research according to the principles of GLP for Genotoxicity Testing, Animal Toxicology, Safety Pharmacology, Analytical, and Bioanalytical Studies apart from DMPK, Exploratory studies, and method development & validation.

Now CROs are more focused and client-oriented. They believe in the delivery of quality results within stipulated timelines in this cut-throat competitive world of drug development. To achieve the timelines CROs are appointing qualified scientists to perform and analyze the studies. For multidisciplinary tasks subject matter experts are also included for the best possible outcomes allowing for the acceptance by regulatory authorities. Besides drug safety, environmental safety is also a concern and CROs provide testing for biosimilars, peptides, protein drugs, vaccines, and other novel biologics drug products.

To conclude, quality data from a quality system through toxicity studies will provide a strong base for further clinical trials or chemical use and generate a belief in the safety of pharmaceuticals and the environment. DaburResearch Foundation (DRF), which is OECD-GLP certified CRO has the requisite expertise to undertake toxicity studies in rodents and non-rodents to provide quality data for regulatory submissions with complete client satisfaction.