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
    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
    More+