Adherence to Good Laboratory Practices (GLP) by pharma and biotechnology industry is essential because it assures that the work is performed by qualified personnel under proper directions in adequate facilities with calibrated and maintained equipment using standard operating procedures(SOPs) and providing a report that has been reviewed by a quality expert. The adherence to GLP is all the more critical since global regulators are now keeping a hawk's eye on the Indian industry now.
The union government has made GLP mandatory vide G.S.R. & 780 (E) under schedule L-1 with effect from November 1, 2010.There are a handful of norms prevailing in the country. These include the Indian Pharmacopoeia which provides stringent requirements of more sophisticated and state of the art equipment/ instruments like IR, ASS, HSGC etc.
Professional organizations like Indian Pharmaceutical Association (IPA), IDMA, BDMA and FOPE etc sensitize the manufacturers and approved laboratories through workshops. Department of Science & Technology which established the National GLP Compliance Monitoring Authority in April 2002 is now working to inspect the laboratories, facilities for approval as a testimony of their compliance to the required standards to meet international acceptance.
According to Dr. BR Jagashetty, former Karnataka drugs controller, since the introduction of GLP in 2010, the industry should have adapted the norms over the last four years. The enforcement officials across the state drugs now need to inspect and issue notices if there are any infringement of norms.
The state drugs control inspectors also audit government labs. In this context it would be appropriate for the Drug Test Labs (DTLs) of the state DC departments also opt to self regulate to ensure GLP compliance. For this a national/state committee needs to be appointed to audit DTLs. It would help to make sure that all protocols and procedures are in place by the regulator’s labs too. In fact, it would give the monitoring authority a first-hand experience on what to examine during a lab inspection, pointed out Dr. Jagashetty.
Another point is that labs also need to maintain details of drugs whether it was as per Indian Pharmacopoeia, British or US Pharmacopoeia. If the drug is out of purview of these standards, then the industry should provide the information of their own methods adopted. Now during a drug inspection drive, sourcing of information on ‘method of analysis’ for any drug marketed across the country, the state drugs control department can access the information from the counterpart offices in any state. This is the biggest achievement for the regulator. However to accomplish this effort, total computerization and networking is the need of the hour. In an era of SMAC or social media, mobile analytics and cloud computing the ability to economize time and ensure transparency would lead to complete compliance of GLP, pointed out Dr. Jagashetty.
Indian companies should adopt information technology solutions for GLP with lower upfront investment. First is that our cloud-based approach will help companies to integrate different business processes related to GLP quickly and efficiently. The second is on a mobile device based application capture of electronic data as and where it is produced would improve efficiency and reduce data loss. Third is the attention to cloud-based Big Data Analytics solutions. It will enhance storage, retrieval and analysis of data to generate real-time/results as and when required, said Somenath Nag, Director, ISV and Enterprise Solutions, Alten Calsoft Labs.
According to Dr Manu Chaudhary, joint managing director, Venus Remedies Ltd and director, Research, VMRC, the GLP accreditation, one of the most coveted certifications for R&D capabilities. For us, it is yet another significant milestone in our efforts to ensure product quality, safety, reliability and excellence while preserving and improving human life through innovation. It gives our research an international credibility and will translate into more business opportunities for the company and add to the reputation of our products and personnel.
According to Dr. HV Raghunandan, Deputy Director – Academics, JSS University, Mysore, GLP ensures the reliability of data and also product quality and safety. It is applicable to chemicals, food additives, cosmetics and pharmaceuticals for humans and animals. India has set up the GLP under National Good Laboratory Practice which is with Department of Science and Technology. The certification is compulsory to have before marketing any products. GLP is an essential certification even for the bio availability and bio equivalence labs. Most of the laboratories are meeting these standards in India and the products manufactured and tested from such companies are being exported also. In pharmaceuticals manufacture, GLP L1 compliance is a essential because it gives an assurance to product safety and its efficacy.
GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. Its implementation has also brought in Good Laboratory Quality Assurance. Schedule L1 requirement of Drug and Cosmetic Act 1940 is almost in line with the WHO and other international GLP guidelines. Implementation of L1 guidelines will be helpful to all the stakeholders in the country, Dr. Raghunandan added.