Central Sterile Service

Since From 2019

INTRODUCTION

Introduction Central Sterile Service LLC was established in 2019 to manufacture and supply medical devices. It was built with a GMP approved design. The factory building is:
The general requirements for pharmaceutical production MNS 5524:2014 and GMP standards are met with an infrastructure that meets the requirements of the international standard ISO 13485, and the ventilation system is equipped with a control device with a HEPA filter.
The requirements for pharmaceutical quality control laboratories applicable to pharmaceutical production activities are met with a control laboratory that meets the requirements of the ISO17025:2018 standard.
The Central Sterile Service factory operates with advanced technology-based techniques and produces safe and quality-assured medical products that meet the health needs of consumers, and operates under conditions that meet the requirements of storage, transportation, and good practice GSP.
The pharmaceutical factory license will be obtained in 2022 and is in the process of product production trial registration.
In its sterilization and disinfection product production, it produces about 50 branded products and supplies them to consumers
Specifically, we are working together to sterilize sterile gauze with EO and supply it to hospitals of all levels for use during surgery.
We are registering 4 brands of vitamin pills in the health supplement industry and supplying them to consumers.

QUALITY POLICY

CENTRAL STERILE SERVICE LLC will adhere to the following quality policy in order to contribute to the sustainable development of Mongolia.

Environment: We are a national eco-manufacturing company of medicines and medical devices that respect natural resources and replace imports with advanced technologies that incorporate environmentally friendly innovations.

Society: We will work to provide the population with safe, quality-assured, highly active modern therapeutic medicines and medical devices that meet the requirements of healthcare legislation, ISO 9001, ISO13485, GMP, GLP 17025, and GSP international standards, and to provide the market with uniform, affordable, and continuous access to them.

Governance: We will strengthen our skilled workforce in our field and continuously improve our operations in accordance with the international standard of ISO 9001 QMS.

INTRODUCTION

QUALITY POLICY

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