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Who GMP

GMP is a critical concept in pharmaceutical industry. According to World Health Organization (WHO), Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled, according to quality standards. GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biological including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.

ISO 9001-2015

ISO 9001:2015 is an international standard dedicated to Quality Management Systems (QMS). It outlines a framework for improving quality and a vocabulary of understanding for any organization looking to provide products and services that consistently meet the requirements and expectations of customers and other relevant interested parties in the most efficient manner possible. The QMS is the aggregate of all the processes, resources, assets, and cultural values that support the goal of customer satisfaction and organizational efficiency. ISO 9001:2015 certificate is an added value to pharmaceutical companies to ease import and export potential of quality products.


FSSAI Licence

FSSAI stands for the Food Safety and Standards Authority of India, responsible for the issuance of food licenses to food business operators. It is the apex body incorporated by the Ministry of Health and Family Welfare; Government of India is accountable for setting up standards for selling, packaging or storage of eatables items in India. Additionally, it was set up under the Food Safety and Standards Act, 2006. FSSAI registration in pharmaceutical industry is used for manufacturing on third party basis of the allopathic medicines on the contract basis.