quality commitment
that is the best commitment for authorities and customers that
we ensure continuously controlling and improving quality always under iso 9001/current gmp standards/requirements and customer requirements, which are fulfilled properly at first time.
quality system structure
- the quality system structure is designed based the gmp requirements consists of ceo, corporate quality platform, and quality units in factory.
- ceo is the top decision - maker for abachem quality.
- corporate quality platform in abachem keep independence compared with production system and fulfills the quality responsibilities authorized by ceo .
- every quality unit in each production base also keep independence compared with production system and fulfills its qa and qc responsibilities respectively.
quality management system
quality management activities
the main daily quality management activities are pdca (deming cycle) in abachem.
quality document system
the document system structure is divided into home office and local/plant documents in abachem.
each local/plant document structure is established based cgmp/iso 9001 and corporate document requirements.
the main quality management flow of the plants (gmp required)
flow are classified into 6 systems (qa /qc /material /production /equipment & facilities /labelling) according to us fda inspection guideline and established mainly according to ich q7 and local gmp.
the list of main flow is as follows:
quality system procedure for abachem web q-info version 01 201604.docx
the main daily quality management activities are pdca (deming cycle) in abachem.
quality document system
the document system structure is divided into home office and local/plant documents in abachem.
each local/plant document structure is established based cgmp/iso 9001 and corporate document requirements.
the main quality management flow of the plants (gmp required)
flow are classified into 6 systems (qa /qc /material /production /equipment & facilities /labelling) according to us fda inspection guideline and established mainly according to ich q7 and local gmp.
the list of main flow is as follows:
quality system procedure for abachem web q-info version 01 201604.docx
| r&d lab and qc analytical apparatus | |
| hplcs | 48 |
| gcs | 8 |
| lc-ma & gc-ms | 5 |
| nmr | 1 |
| mettler toledo kf titrator | 3 |
| moisture analyzer | 2 |
| spectrophtometer | 2 |
| advanced reactive system screening tool（arsst） | 1 |
| differential scanning calorimetry（dsc） | 1 |
| uv/ftir | 6 |
the list of main quality management flow
| no. | flow description | requirements of ich q7 chapter/ ich q7 | system |
| 1 | qa responsibility | 2.20、2.21、2.22 | qa |
| 2 | change control management | 13.10、13.11、13.12、13.13、13.14、13.15、13.16、13.17 | qa |
| 3 | disposition of sub-quality products | 14.10、14.20、14.21、14.22、14.30、14.31、14.32 | qa |
| 4 | product return | 14.50、14.51、14.52 | qa |
| 5 | product recall | 15.13、15.14、15.15 | qa |
| 6 | analytical method validation | 12.8 | qa |
| 7 | approval of supplier qualification | 7.11、7.12、7.13、7.14 | qa |
| 8 | sample incoming material | 7.10、7.30、7.33、7.34、7.35 | qa |
| 9 | customer complaint | 15.10、15.11、15.12 | qa |
| 10 | internal audit | 2.40、2.41 | qa |
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