Organization and Responsibilities

Personnel QA: 4, QC: 9

Personnel Structure

Responsibilities
The quality unit is divided into two departments - QA and QC.The quality unit is responsible for carrying out
sufficient quality supervising and quality control throughout the whole production process.

Documentation System
The company has established its documentation system of five layers.
The five layers are: 

Instrument in QC
In order to meet the requirements of production control and QC manegement, the company has equipped
with comparatively completed advanced analytical instrument and test equipment. Mainly includes:

Training
· Dedicated personnel in the Management Department are assigned to be responsible for training;

· Training Plan is available: There is overall training plan at company wide level and the individual department also has its own professional training program;

· Covers different management levels: middle management, common administrative staff and operators;

· Covers different stages: for a new post, at the current post and before transferring to another post;

· Throughout multiple ways: to be trained outside the company and to invite external experts to conduct training as well;

· Applies training card system: one card for each employee to record the history of his/her training.

Validation

To establish and perfect the validation system, conduct effective validation and standardizing the validation documents.

Content of validation includes:

· Process validation

· Cleaning validation

· Purified water system validation

· HVAC validation (HAVC validation?)

· IQ, OQ and PQ of equipment and instrument