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Quality at Alkem is patient centric and infinite


Quality at Alkem is patient centric and infinite

Impeccable quality and Alkem go hand-in-hand because the organization is strongly held by the foundation of patient satisfaction and an excellent work ethic. Our every action is triggered by empathy for patients and the unflinching commitment to fulfill their unmet needs. This helps us create apex quality products to provide them with the care they need and meet their expectations.

We ensure transparency in every aspect of all our operations including research and development, technology transfer, and commercialization of the product, enabling us to create a robust work culture in the organization. We sustain and simplify our operational excellence through the 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 the Continuous Improvement Program.

To ensure the consistent quality of the developed products, Alkem adheres to the concept of ‘Quality by Design’ (QbD) whereby the R&D, manufacturing units, and quality control laboratories endeavor to meet and exceed global standards concerning safety, quality, and efficacy. Alkem has established a strong supply chain network that assures the availability of all its products to its consumers/patients readily. Alkem has a robust and mature Quality Management System (QMS) which ensures that every product it develops, manufactures, and distributes complies with the applicable laws and statutes of the target country. Skill development of employees is an integral part of Alkem’s QMS to meet global standards through internal and external training. The company fosters a strong quality-conscious culture to assure that products meet the highest quality standards. Alkem strongly believes in continuous and sustainable improvement in the overall process to build, simplify, and establish a sustainable product supply chain.


We have introduced various technologies and automated operations at our facilities and operations over the last few decades. These include the use of digitalized systems such as enterprise resource planning (SAP), electronic Batch Manufacturing Record (eBMR), Laboratory Information Management Systems (eLIMS), Document Management Systems (eDMS), Training Management System(eTMS), Quality Management Systems (eQMS), PLC modernization of equipment and instruments, integration of systems, etc.

All stakeholders, including employees, vendors, and partners comply with the stringent Code of Conduct defined by the Alkem policy that adheres to required national and international regulatory and business standards and guidance. All the manufacturing facilities of Alkem comply with the regulatory norms of the respective countries like Schedule M for India, various sections of Chapter 21 of Code of Federal Regulations (21CFR) for the USA, GMP requirements for European Union (EU) as defined in Eudralex, World Health Organisation guidance for GMP compliance (WHO-GMP), Orange Book guidance of the UK MHRA, TGA guidance for Australia, and other relevant applicable guidance for the rest of countries. Inspections are periodically performed for different manufacturing facilities of Alkem by various regulatory agencies of different countries of the world as per the relevant cGMP guidelines. Our manufacturing sites are inspected by CDSCO, USFDA, MHRA - UK, BfArM-Germany, Medicines Authority - Malta, BDA – Bulgaria, SAHPRA - South Africa, TGA - Australia, ANVISA - Brazil, WHO - Geneva, ISP – Chile, TPD - Health Canada, PPB - Kenya, NDA - Uganda, MOH - Sudan, INVIMA - Colombia, TFDA - Tanzania, Zimbabwe, & Other Africa, Asian & CIS Countries.

Our commitment to quality also gets extended to our business partners and service providers. We insist they comply with global quality standards that align with our own. Our benchmark of quality is inspired by the best global practices. We continuously evolve and upgrade our QMS to match the changing dynamics of the global environment.

We are committed to delivering the highest quality, and our every facility and legal entity is steadfast to meet the impeccable standards expected from a global pharmaceutical company.