Manufacturer
Date: 2016-12-02 15:29:36.0
MANUFACTURER
Unit : production department
From the first period in the past that the factory had produced general medicines to sell such as Paracetamol, Diclofenac, stomach enamel medicines, Bangkok Lab & Cosmetic co.,ltd. has been continuously developing the production efficiency until the present. There are drug products and we have expanded production line to cover cosmetic products. We have produced quality and standard goods that were acceptable in a large scale more over a hundred items.
The company has operated the business by focus on the security in every aspects. It must be the minimal environmental impact both water system and air system that released outside the factory according to law. The importance is quality control to be standard and regularity. In accordance with the rules and good procedures in production, we focus on 3 main issues: Place, Person and Machine.
Place
It was designed and installed protective equipment to protect from animals and insects invasion.
Walls, floors, and ceilings must be smooth, no crack or weld that are not tight, no corners, do not release particles and easy to clean
The area of operation must be efficient ventilation and have facilities to control the air such as temperature, humidity and air filtration by HVAC system (Heating Ventilation Air Condition) that are efficiency and standard.
In the area of drug production must be clean in the level of Clean Room Class 100000 or Class D according to EN/ISO 14644-1 system.
Work must be designed and planned in orderly to avoid mixing and to protect cross contamination by controlling the pressure in the production rooms that contact with products and pavement accordance with the standard set.
Building production is closed system and use air lock system (the completely closed area that have 2 doors or more to separate between the different level of cleanliness area). It is used for the entrance of people and goods in order to prevent contamination of product.
Person
- Must have enough qualified and experienced personnel.
- The personnel must be trained before work and have continuously trained.
- Workers must wear Cleanroom (Lint Free) uniform that do not release particles and tightened to prevent any contamination to the product in the production process.
- They must understand the job descriptions and aware of the rules and good procedures in production, also regarding to the quality throughout the production.
Machine
The imported machines must be qualification that is one part of the validation to assure the right work of equipment and work well as expected. The Qualifications consist of
Design
qualification
is a proven and documented to confirm that the facilities, system and machines are suitable for the intend purpose.
Installation
qualification
is a proven and documented to confirm that the facilities, system and machines, which were installed or improved, are right design according to certification and suggestion of producer.
Operational
qualification
is a proven and documented to confirm that the facilities, system and machines, which were installed or improved, can work as the purpose throughout the time set.
Performance
qualification
is a proven and documented to confirm that the facilities, system and machines that connect together can work effectively and be able to repeat it by means of a certified process and product specifications.
