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Quality Management System
Tuesday, 10/10/2006, 10:00

Targeting at creating high-quality products, STADA-Vietnam maintains a well-established and continuous developing quality management system in accordance with EU-GMP. In addition to multi-level scientific documentation system prepared and managed by an experienced, competent staff, STADA-VN employs technology and synchronous automation as an effective tool for quality management and risk minimization.

 

Application Software in Production Equipment

Most of the equipment in production areas are controlled by Programmable Logical Controller (PLC) to set parameters of production and ensure uniformity of each batch.
Device in the manufacturing sector are equipped with SCADA systems to ensure control, manage the database and history of the production processes.
All software used in the processes of manufacturing and testing meet the requirements of 21 CFR part 11.

 

Heating, Ventilating, Air-conditioning (HVAC) System

An HVAC system consisting of 60 air handling units (AHUs), 6 special dehumidifiers, a dust collecting system, chillers and an air ducting network are designed and installed in compliance with EU-GMP requirements, to ensure that the environnement in production and storage areas satisfy the temperature, humidity and cleanliness required by the European GMP.

 

BMS System for Controlling Production Environment

Building Management System (BMS) controls humidity, temperature and air velocity with the support of SCADA system for the control, monitoring and data acquisition complying with requirements of EU-GMP. The system assures all materials and products are processed in good condition, minimizing risk factors of cross contamination and alerted when problems arise.

 

RO-CDI Purified Water System

Advanced water treatment technologies such as RO-CDI for water purification, hot water sanitization, automated control through PLC, electro polishing, pipe fitting and orbital welding are customized in the water system in order to generate purified water in compliance with the criteria stated in European and US pharmacopoeia. 

 

“Calibration Schedule Manager”

Management software is utilized to alert of maintenance schedule for production equipment, to test and calibrate equipment and sensors, and notify of necessary repairs. The software has been reviewed and assessed under the provisions of 21 CFR part 11 of the GMP - United States.

 

QUALITY CONTROL

STADA-VN’s quality control department was established in accordance with GLP requirements with experienced qualified analysts, state-of-the-art instruments and validated testing procedures in order to facilitate quality control and stability of commercial products in accordance with ICH rules. 

Data archive and acquisition are checked and updated on a regular basis on system equipment, which are connected to a server and management software application that has been evaluated under 21 CFR part 11, matching the European GMP, WHO and FDA standards to ensure accuracy, safety and the ability to recover data in case of incidents.

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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