Quality

COOLLABORATE
Ensure employees know how the contribute to improving quality and have the necessary skills and support to do their jobs. Build strong confidence and trust in our partnerships with our valued customers and suppliers.

ADVOCATE
Follow Health Dynamic, Listen to customers, understands their needs and creates positive customer experiences.

IMPROVE
Design processes to deliver customer value, follow our process, and continually improving the quality and reliability of our products and services.

DELIVER
Research, manufacture, and deliver best-in-class quality and reliability in our product and service

"BICHAL" is certified according to ISO 9001:2008, allowing us to meet customer and legal demands in a uniform and predictable way.

Responsiblities

The quality unit is divided into two departments-QA (4 persons)and QC(10 persons), the quality unit is responsible for carrying out sufficient quality supervising and quality control throughout the whole production process.

Documentation system

The company has establised its documentation system of five layers
the five layers are:

1. MP Management policy
2. SMP Standard managerment procedure
3. STP Standard technology procedure
4. SOP Standard operation procedure
5. BPR Batch production record
REC Other record

Instrument in QC

in order to meet the requirements of production control and QC management,the company has equipped with comparatively completed advanced analytical instrument and test equipment, mainly includes:

IR spectrophotometer
UV spectrophotometer
AUTO Polarimeter
HPLC-MS
GC
Melting point Instruments
Electronic balance

Trainging

Dedicated personnel in the management deparment are assigned to be responsible for traing.
training plan is vaailable:there is overall traing plan at company wide lever and the individual depratment also has its own professional training program.
covers different managerment levels: middle management common administrative staff and operators
covers different stage: for a new post, at the current post and before transferring to another post.
Throughout muliple way: to be trained outside the company and to invite external experts to conduct training as well;
Applies training card system: one card each employeed to record the history of his/her training

Validation

To establish and perfect the validation system, conduct effective validation and standarding the validation documents,content of validation includes:

Process validation
clearing validation
Purified water system validation
HVAV validation
IQ,OQ and PQ of equipement and instrument