How Cadila Pharma’s pre-clinical department got GLP (Good Lab Practice) certification?
Giving exams has never been someone’s hobby. Everyone dreads it. Because exam means sleepless nights, going through the entire syllabus, giving mock tests and then finally be prepared for the big day. Finally, if our efforts have been sufficient, we pass the exam with flying colors. This means that we are eligible to attend classes of the next grade or in vocational courses such as law or medicine, we are now eligible to practice. When education ends, we believe we are past exams. But exams only mean growth. Cadila Pharmaceuticals’ R&D department recently underwent one of the toughest exams in the field of research. Fortunately, we were successful.
At Cadila Pharmaceuticals, to ensure the top quality of drugs, we follow all of the mandates dictated by the national and international agencies. Recently, we applied to obtain a GLP (Good Lab Practice) certification, and after months of hard work, we finally obtained it!
Our Pre-Clinical Department has received GLP Compliance Certification from the National GLP Compliance Monitoring Authority (NGCMA), Department of Science and Technology, Government of India. This means that whatever data we generate will now be acceptable by international regulatory authorities including OECD member countries. Our Animal Facility is also recognized by the Committee for the Purpose of Control and Supervision of Experimentation on Animals (CPCSEA) which is a regulatory body under the Ministry of Environment and Forests (Government of India).
We have our own separate functional areas such as Toxicology, Efficacy, Animal breeding, Pathology, Microbiology & Mutagenicity, Test item control office (TICO), Archive, Analytical Laboratory and Support Services i.e., Engineering & Maintenance, Safety , etc. which are continuously monitored by independent Research Quality Assurance and test facility management.
We offer comprehensive solutions for integrated drug development such as Proof of Concept studies, efficacy studies, and toxicology studies to various regulatory studies, which comply with the Organisation for Economic Cooperation and Development (OECD) Principles of GLP. We offer regulatory solutions related to non-clinical health testing of pharmaceutical products, vaccines, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals, etc.
While the other Contract Research Organization (CRO) of India offers only toxicity studies, we excel in both toxicity and efficacy studies. This gives us an edge as we can understand the drug in detail and provide better insights in terms of side effects and toxicity. This information is used to make our drugs more reliable.
Getting GLP certified is not an easy feat. Our labs had to be in accordance with the guidelines dictated by NGCMA (preparing the syllabus), we then underwent pre-audit (mock test) followed by the main audit (the actual exam). Since our team had worked hard enough, we passed the multiple tests and were awarded the GLP certificate. We passed the exam with flying colors strengthening our core philosophy of ‘care’.