QUALITY MANAGEMENT

Quality Assurance

We are obligated to produce high quality products and corporate responsibility obligation.

We are determined to establish a high quality process started at early stage, from selections of the raw materials sources, upto the final production stage, continued to storage and distribution.

The entire staff and employees always be motivated to work with discipline, complied to written rules and regulations approved by the Quality Assurance Department.

We provide internal trainings for staff and employees. These trainings are of an assurance for the performance of operators to always in the utmost awareness to produce high quality control of all processes, activities, and other documentation related to the c-GMP.

Quality Assurance Department is responsible in monitoring the implementation of Quality Management System.


Quality Control

Quality Control Department is an important part in assuring that Quality Management System is fully implemented. The high quality system is for the whole aspects including: raw material, packaging material, manufacturing process and warehousing. Implementing the Good Laboratory Practices (GLP).

The accuracy of analysis and test result is guaranteed as the QC laboratories are supported by sophicticated Equipments such as:

- HPLC (High Performance Liquid Chromatography).

- UV Vis Spectophotometer.

- Dissolution Tester.

- LAF (Laminar Air Flow Cabinet) ,etc.

Microbiology Laboratory facility for examining the limit of Pathogen Microorganism and Fungi.


Validation

Procedures to Proving the continuous constant quality in all materials, processes, procedures activities, systems equipment/mechanism used in production and quality control

Several kinds of Validation :

- Validation on Machine qualification, Supportive Tools, Production system and equipments.

- Validation on Analytical Method.

- Validation on Production Process.

- Validation on Packaging Process.

- Validation on Cleaning Equipment.