Laboratory Services

Professional comprehensive · One-stop service

the life cycle of QC services

New Laboratory → Commission and Qualification →Method Establishment →Continuous Operation → Relocation and Transfer

Gap Analysis
服务范畴

  • Find the weak points and problems of systems

  • Transform plans into actions

  • Monitor Processes and Evaluate the effectiveness of actions

  • Provide possible corrective actions and check the effectiveness of solutions

Laboratory Data Quality
服务范畴
  • Quality control check samples                          ⇒   Ensure the accuracy of sample analysis
  • System suitability tests                                       ⇒   Ensure the system to achieve the desired objectives
  • Analytical method validation and verification   ⇒   Analytical method can achieve the purpose
  • Analytical instrument qualification                     ⇒   Prove the instrument meets the expected purpose

Stable analytical instruments are the basis for obtaining accurate and reliable test data

Management of Analytical Methods and Analytical Instruments

QC is one of important departments in the process of drug production and control. An important part of GMP regulations is laboratory quality control and product testing. Correct validation should be carried out before the relevant instruments, equipments and analytical methods are used for inspection.

QC Validation
  • Verification and Validation of Physical and Chemical Analytical Methods
  • Verification and Validation of Microbiological Analytical Methods
  • Validation of New Analytical Methods
  • Verification of Analytical Methods
  • Transfer of Analytical Methods
  • Verification and Validation of Analytical Instruments
    • QC Equipment /systems
    • QC Analytical Instruments
QC Documentation
  • SMP: procedures about QC Basic Management, Instrument Management, Method Management , Test Management, Data Management and so on.
  • SOP: procedures about QC Project Inspection Operation, Drafting of Quality Specification, Testing Instrument Operation, Instrument Maintenance and so on.
  • Inspection Records and Forms: Batch Test Record, Reagent Preparation and Distribution  Records , Instrument Calibration and Maintenance Records and so on.

Other Services

QC Sample Inspection
  • Process water testing:
    • Sampling and testing during validation of PW system
    • Sampling and testing during validation of WFI system
    • Sampling and testing of PS system
  • Raw materials Testing:
    • Drafting raw materials specifications
    • Drafting raw materials SOPs
    • Chemical testing of raw materials operation verification and daily testing
    • Microbial limit and endotoxin test

 

QC Training
  • Professional training on laboratory basic operation
  • Professional training on analytical instrument management 
  • Professional training on analytical method management
  • Professional training on microbiological knowledge
  • Professional training on QC data integrity