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GMP CERTIFICATE
โครงการสถานที่ผลิตอาหาร
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HALAL CERTIFICATE
ISO 9001:2000 CERTIFICATE
ABRIEF ON OSI'S MENUFACTURING FACILITIES
INTRODUCTION
OSI Facility in Thailand has been designed and developed in compliance with WHO guidelines required for Good Manufacturing Practices to ensure quality of products appropriate to their intended use.
OSI produces various dosage forms of which are tablets, capsules, liquid preparations for oral and external use, cream and ointment as well as powder.
MANUFACTURING AREAS
OSI plant has separate areas for the production of penicillin and non-penicillin products. These are equipped with automatic and semi-automatic machinery and operated by a group of qualified, trained and experienced personnel.
Our production area has been designed and constructed based on GMP guidelines. Each unit of production area is apart of each other to prevent cross contamination and for ease of operation.
The Good Manufacturing Practices started from the beginning to the end of the manufacturing process.
We select carefully to ensure the best quality from the beginning. All incoming materials are checked by our versatile Quality Assurance team.
Bar coded computerized starting materials weighing system is used to ensure the identity and prevent mix up errors before entering the production line.
QA SYSTEM AND QC LABORATORY
The Quality Assurance System covers all function of production and quality control activities according to GMP and Good Practices of Quality Control. It takes part from selection and quality control of materials through manufacture processing control, validation activities, equipment calibration , environmental monitoring, batch documentation including stability program in order to assure the product quality.
The modern laboratories for physico-chemical test as well as for microbiological test are fully equipped with high technology instruments such as HPLC, Spectrophotometer, Dissolution appparatus, moisture analyzer, etc. which are operated by qualified , high experienced technical personnel.
PRODUCT DEVELOPMENT
The plant's product development, equipped with small scale production and QC equipment is under the responsibility of competent pharmacists mastering in research and development.
GRAPHIC DESIGN
The Mackintosh and advanced graphic program enable our designers to create the attractive packaging materials. They focus not only on product appearance but also the quality of packaging materials to preserve products quality as long as possible. In addition, marketing printed materials, POP's and multimedia can be produced to suit each customer needs.
WAREHOUSE
OSI spacious storage area allows the proper storage of raw materials, packaging materials and finished products. Temperature and relative humidity in controlled storage area are monitored regularly. A periodicaly pest and rodent control program keeps the store safe and free from the possible infestation.
MAINTENANCE FACILITY
The plant is supported by own maintenance workshop run by qualified technicians. It is adequately equipped with tools required for maintenance work in the plant.
The preventive maintenance program is set up to prevent unexpected break down of production machinery which can cause interruption of production and delay delivery .
ENVIRONMENTAL HEALTH AND SAFETY (EHS) ACTIVITIES
The company has an Environmental Health and Safety (EHS) Committee to take care of environmental and safety working condition. The committee consisits of representatives from every section. They will have a monthly meeting to discuss about accidents occurred and how to prevent. The safety training schedule including fire fighting and evacuation is planned and implemented.
OSOTH INTER LABORATORIES CO.,LTD.
747/132-130 Soi Pradoo 1 , Sathupradit Road , Bangpongpang , Yannawa , Bangkok 10120
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