Conforms to cGMP conditions and has WHO GMP Certification in India and approvals from USFDA, EMEA and Japanese regulatory authority in Sweden

	Overview

	Quality Control

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“Quality is an important part of almost all projects. We add value across the entire production chain, from buying the raw materials until the finished products leave the plant. What feels best is when we succeed with improvements, resulting in better operations."

- Mikael Meisengseth

Director Quality Operations,

Site Uppsala, Kemwell

Quality - the foundation of success

Kemwell meets current Good Manufacturing Practices
(cGMP) as per International Quality Guidelines and continues to invest in people, processes and equipment to ensure that Kemwell remains a quality leader in every aspect of our business. Our Quality System is the
foundation of our operations and through comprehensive SOPs, rigorous training and a range of process controls, we ensure that all products meet the highest quality standards.

The Quality System

	Quality system conforms to cGMP conditions and has WHO GMP Certification in India and has been inspected by the USFDA, EMEA and Japanese regulatory authorities in Sweden.

	Facilities are fully approved and periodically audited by Corporate Quality Teams of our customers.

	Encompasses all GMP related activities at the site including manufacturing, laboratory and validation.

	Systems in place for deviations, complaints, change control, documentation control, CAPA, validation, pest control, training, etc.

Committed to quality compliance

The Company is dedicated to strict cGMP compliance and the methods, facilities and controls used for the manufacture, processing, packaging and holding of all finished pharmaceuticals produced at Kemwell are in accordance with the applicable sections of cGMP regulations. A continuing employee training program, equipment and process validation, and a self-inspection program are part of our commitment to quality assurance. The entire company is committed to an ongoing quality improvement process. Special emphasis is placed on thorough documentation and review of the entire manufacturing and control process. The documentation system and customized batch documents assure that requirements have been met. These documents are reviewed and updated as necessary to maintain quality standards.