Quality
QUALITY
Maruti Biogenic Quality as a center 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. Our focus over the past few years has been to enhance our Quality Management Systems to meet and exceed the current expectations of regulatory authorities such as FDA.
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 globally. 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.
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, demanding compliance requirements and stringent quality standards as a result of our robust Quality Control systems. The Company functions on a business model with a futuristic outlook that envisions the anticipated regulatory developments. This prepares us to adapt readily to the changing environment and ensure business continuity.
ENSURING QUALITY
We understand that adequate and timely investment in strengthening our quality management protocols promise long-term benefits in terms of eliminating cost of failure, enhancing stakeholder confidence and bolstering legal compliance.
We have state-of-the-art manufacturing facilities that are cGMP compliant in conformity with national and international standards. Additionally, the first phase of Laboratory Information Management System (LIMS) has been completed across all Maruti Biogenic Quality Control Laboratories which significantly improve compliance in our laboratories’ data management.
Our facilities ensure quality through constant upgradation of equipment, adoption of technological advances and implementation of industry benchmarked practices. We have developed a robust system to manufacture products that adhere to stringent specifications & in-process controls subsequently leading to high product quality.
PHARMACOVIGILANCE
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. Through a structured customer complaint redressal system, complaints related to drug safety are directed to the pharmacovigilance team. 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. Investing in these critical elements of pharmacovigilance captures improvement areas and aids in standardising and streamlining processes. The redressal mechanism is supported by a dedicated phone line and a mailbox wherein, safety-related complaints are received from consumers, patients and healthcare professionals. We have an established SOP for diligent follow up with the reporter for each complaint received. As a part of this follow-up, we enquire about the patient’s safety and obtain adequate information to assess the safety profile of a drug. Our field team, being an important link between the company and end-users, is sensitised periodically about the importance of patient health and safety through appropriate trainings.
We strive to update our pharmacovigilance practices by improving resource allocation, establishing effective partnerships with vendors and implementing governance mechanisms to adapt ourselves to the changing regulatory landscape. As a multi-national company, we undergo investigations and inspections conducted by bodies such as The Medicines and Healthcare Products Regulatory Agency (MHRA) and The Agency for Medicinal Products and Medical Device (HALMED).
