QUALITY AT ALKEM IS PATIENT CENTRIC AND INFINITE
Quality and Alkem are synonymous! For us Alkemites, patient satisfaction is the foundation on which the organisation rests. Our every action is triggered by empathy for patients and the unflinching commitment to fulfil their unmet needs. This helps us create apex quality products to address the needs of patients.
We believe in maintaining transparency in every aspect of our operation, which has helped us in creating a robust work culture in the organization. Quality par excellence is our defining attribute at every location and our every operation. We are conscious to sustain and simplify our operational excellence through implementation of cutting-edge global quality management systems. For us, meeting the global quality and statutory requirements is never enough; our objective is to constantly exceed the expectations of all our stakeholders as a part of Continuous Improvement Program.
Our commitment to quality and compliance begins with research & development and continues during technology transfer and commercialization of the product.
Our Quality Management Team is an overseer, which ensures that each of our products stand true to the global standards of quality, purity, efficacy and safety. The quality unit at our sites are guided by a Corporate Quality Assurance (CQA). CQA ensures that the latest updates in Good Manufacturing Practices (GMP) are being translated into our policies, guidelines and Standard Operating Procedures (SOPs). Quality unit at respective sites further ens ures that these guidelines are implemented to consistently deliver top-notch products across all territories. In addition to this, the manufacturing sites are regularly audited by CQA to ensure 24x7 compliance and conformance. In addition, our quality management team is also involved in overseeing compliance with respect to Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).
Our training management system, Document management system & Quality management system are effectively handled through various application softwares such as eTMS, eDMS, Trackwise, eLIMS which significantly helps to ensure compliance.
Alkem strongly believes in continuous improvement and upgrades its product, process, equipment and systems as per advance global technology.
To maintain quality standards, we have placed compliant procedures and system at each of our manufacturing facilities. These procedures and systems are in compliance with the requirements of the Current Good Manufacturing Practices (cGMP) and our systems meet the global standards of regulators, such as the USFDA, MHRA - UK, SAHPRA-South Africa, TGA - Australia, ANVISA - Brazil, WHO - Geneva, TPD - Health Canada, PPB - Kenya, NDA - Uganda, MOH - Sudan, INVIMA - Colombia, TFDA - Tanzania, Zimbabwe, BfArM-Germany & Other Africa, Asian & CIS Countries. Our well-trained and competent colleagues ensure strict adherence to systems and procedures.
Our persistent commitment to quality also gets extended to our business partners and service providers. We insist that they comply with global quality standards which are aligned with our own. Our benchmark of quality is inspired from t he best of global practices. We continuously evolve and upgrade our quality systems to match with the evolving dynamics of the global environment.
We are committed to deliver the highest level of quality and, each of our facilities and legal entities is steadfast to meet the impeccable standards that are expected from a global pharmaceutical company.