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Enabling ServicesQuality Assurance

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Quality Assurance

At Soneas Chemicals Ltd all manufacturing procedures are carried out according to ISO 9001 standard in-line with our comprehensive quality management strategy. Besides that, at Soneas Chemicals Ltd Illatos Site we are following the cGMP regulations (the principles described in EudraLex Vol. 4 and ICH guidelines) as well.
Soneas Enabling Services | Quality Assurance
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Our Quality Management System focuses on management of documentation and records, manufacturing procedures including material and laboratory controls, training, change control, out of specification (OOS), corrective and preventive actions (CAPA) and deviation management. Soneas Chemicals Ltd Illatos Site is regularly inspected by OGYÉI, the Hungarian National Institute for Pharmacy and Nutrition, member of the European Medicines Agency (EMA).

Five in-house levels of quality are defined. The level applied to a project is determined by several factors relating to the intended use of the product to be made. Along with the clinical development phase of the API, it is important to identify whether the compound given is a starting material, late or key intermediate or API. Each piece of manufacturing equipment is cleaned according to multilevel procedures of the chosen level and special requests of our customers.

Customer visits and audits are welcome. We are ready to provide detailed information about our Quality Management System during visits and audits.

Our policy of continuous investment in our employees and facilities and the improvement of our procedures combined with successful regulatory inspections have resulted in our company becoming an approved manufacturer of APls from preclinical to commercial supply.

We are committed to complying with ISO 9001 standard at all Soneas Chemicals Ltd  Sites and with cGMP regulations at Soneas Chemicals Ltd  Illatos Site, to understanding the requirements of our customers and to providing high quality services for each phase of a project.

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