Purpose

Our Quality Assurance System aims at how to take action regarding protective measures prepared in order to prevent product safety and the possibility of error and increase reliability at every stage of the preparation, production and distribution of products such as pharmaceuticals that directly affect human health in reliable conditions and systems.

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Scope

Implementation of the Assurance System; It covers the risks that may arise due to any reason in one or more of the plant and equipment, production, quality control, storage and shipping steps and the physical, chemical and microbiological risks that may arise from cleaning and disinfection applications.

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Applications

In our company; As all the quality-oriented policies of the quality management organization, it is above everything. Our Quality Assurance Unit ensures the realization of quality policies. cGMP (Good Manufacturing Practices) addresses untestable risks as part of quality assurance and makes quality an integral part of the product. Our Quality Control Unit is the unit that ensures that components such as starting materials, raw materials, bulk-intermediate products, primary packaging and the product, as well as the environment and facilities, are tested and ensured that they comply with standards and specifications.

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Our Quality Management System has been established on the basis of internationally accepted standards and guidelines (ISO, GMP, GLP, ICH, WHO etc.) as well as the regulations published by the Official Authority. Our system will be integrated as these regulations, standards and guidelines are updated.

 

Our cGMP Management System has been defined within the framework of 12 main headings. These titles are respectively;

 

• employee

• education

• hygiene

• Plant and Equipment

• Documentation

• Production

• Quality control

• Storage

• Deviation Notices

• Inappropriate Products

• Recall

• Inner control