Cadila Pharmaceuticals recently received the Good Laboratory Practices Certification from National Good Laboratory Practice (GLP) compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Govt. of India, for their Pre-Clinical Department after an inspection was held from 4th to 6th February 2019. This certificate is for Dholka facility which is capable of conducting toxicity studies, mutagenicity studies, and analytical and clinical testing. Certificate no. GLP/C-135/2019 was issued on May 6, 2019.
GLP is a data-driven system that establishes the use of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives products, etc. do not pose any hazards to human health and the environment.
The inspection includes:
Test Facility Inspection: An on-site examination of the test facility’s procedures and practices to assess the degree of compliance with GLP Principles. During inspections, the management structures and operational procedures of the test facility are examined, the key technical personnel is interviewed, and the quality and integrity of data generated by the facility are assessed and reported.
Study Audit: A comparison of raw data and associated records with the interim or final report in order to determine whether the raw data have been accurately reported, to determine whether testing was carried out in accordance with the study plan and Standard Operating Procedures, to obtain additional information not provided in the report, and to establish whether practices were employed in the development of data that would impair their validity.
Breaking the news Mr. Chintan Patel, Head Pre-Clinical & Innovation Team at Cadila Pharmaceuticals Ltd quoted “We are unique in a way where we can say we are ‘One stop solution’ and in pre-clinical research, we do offer our pharma research experience and expertise for basic research as well as regulatory studies.
With this milestone we are a GLP compliant facility, our regulatory research dossier will have an acceptance in all OECD member countries (>35).
Also, additional support to offer services from NCE synthesis to clinical trials is an added advantage for contracting R&D.