- Quality Assurance
YABEN chemical quality policy
- Science & Fact Based
- Systematic Control
- Continuous Improvement
- Compliance With Requirements
Meet laws, regulations and customer requirements, and continuously control and improve.
YABEN chemical quality system framework
- The quality system framework designed according to GMP requirements includes the CEO, the company's quality platform and the quality departments of each factory.
- The chief executive officer is the highest decision maker of the quality related decisions of Abbott chemical.
- The quality platform of YABEN chemical company is independent of the production system and performs the quality management responsibilities granted by the CEO.
- The quality department of each production base of YABEN chemical is independent of the production system and performs its own QA and QC responsibilities.
YABEN quality management system
- Quality management activities
The main daily quality management activity of YABEN chemical is PDCA activity (Dai Minghuan). - Quality document system
YABEN chemical's document system framework is divided into company level and local / factory level documents. Each local / factory document framework is established according to cGMP / ISO9001 and company document requirements. - Main quality management processes of production base (requiring GMP management)
The process is classified into 6 systems (QA / QC / materials / production / equipment and facilities / labels) according to the inspection guidelines of the US FDA, and is mainly established according to the Mich Q7 and local GMP requirements.
Quality assurance of YABEN chemical pharmaceutical products
Product development stage
R&D Lab and QC analytical apparatus
| Main instrument model |
|---|
High performance liquid chromatograph (detector: VMD \ dad \ ELSD \ rid \ FLD) |
Gas & headspace gas chromatograph (detector: FID) |
Liquid mass spectrometry & gas mass spectrometry detector |
Ion chromatograph |
Liquid preparation chromatograph |
Coriolis / Coulomb moisture detector |
Point titrator |
UV and infrared detector |
Laser particle size distribution tester (Malvern 3000) |
Nuclear magnetic resonance |
Inductively coupled plasma mass spectrometry |
Thermogravimetric analyzer |
Differential scanning calorimeter |
Reaction heat scanner |
