QUALITY AS A CENTRE OF EXCELLENCE
Interbiotics Quality Assurance
Interbiotics Quality as a centre of excellence assures a culture of compliance and follows systematic interventions to consistently meet or exceed quality standards. We believe that the key to strengthening the foundation of a responsible brand lies in consistently achieving high standards of quality in everything we do. Quality is embedded at every stage of our operations, including procurement, manufacturing, delivery and safe product disposal.
We’re committed to achieving zero-defect and implement strict quality controls to ensure that every product released from its manufacturing facility adheres to all applicable quality and regulatory standards. This reputation of delivering consistently high-quality products has helped us to be considered as one of the key partners of choice for multinational Government and Non-Government institutions.
We conduct regular vendor audits to ensure adherence to relevant quality standards across its value chain. The Quality by Design (QbD) team and Development Quality Assurance (DQA) team work closely with the R&D function to monitor quality during clinical trials, tech transfer and developing molecules.
Ensuring Quality
During the manufacturing process, the Quality Control (QC) team establishes and implements robust practices to ensure quality. Post manufacturing, this is reinforced through safe destruction of defective and expired products as well as stringent pharmacovigilance.
We have successfully overcome challenges such as growing regulatory pressures and demanding compliance requirements as a result of our robust Quality Control systems. We understand that adequate and timely investment in strengthening our quality management protocols promise long-term benefits in terms of eliminating cost of failure and enhancing stakeholder confidence.
We have state-of-the-art manufacturing facilities that are cGMP compliant in conformity with national and international standards. Our facilities ensure quality through constant upgradation of equipment and implementation of industry benchmarked practices.
Pharmacovigilance & Safety
Pharmacovigilance is an essential component of quality and enables us to adopt adequate measures to identify and enhance awareness regarding adverse effects of its products. Our robust pharmacovigilance system is equipped to handle and process safety related complaints from multiple stakeholders such as consumers, patients and healthcare representatives among others.
While product quality related complaints are addressed as per the SOP prescribed by Corporate Quality Assurance (CQA), we have developed a global pharmacovigilance system for effective handling and processing of drug safety related complaints. The pharmacovigilance team also undertakes measures to review current literature to understand the evolving drug reactions.
The redressal mechanism is supported by a dedicated phone line and a mailbox. We have an established SOP for diligent follow up with the reporter for each complaint received. Our field team is sensitised periodically about the importance of patient health and safety through appropriate trainings.