Quality assurance

We focus on developing and manufacturing of pharmaceutical starting raw materials and GMP intermediates under ISO and GMP practice.
We have established a documentation system to cover following site master files:
        Documentation and Records Management Systems
        Company Training Policy
        Deviations and error management control
        Product Complaints
        Change Control
        Internal Audit
        Corrective and Preventive Action
        Product Release
        Supplier Approval/Qualification
        Master and Batch production record
        Master and batch test record

We have dedicated QA team to qualify suppliers and to be qualified, dedicated team for quality control of both R&D products and commercial products.
We execute pre-contract audit, assist customer audit, and perform quality verification.

Quality Control:

Quality is controlled based on modern instrument and strict documentations. Tests are performed by analysts with full training of SOPs. Out-of-specs test results will be verified as per OOS investigation SOP, and root causes will be investigated and eliminated. Instrument and measurements are calibrated at certain period to make sure that all data obtained from lab tests are valid.

We have a professional team to develop test method of certain chemicals to shorten the developing time of projects. All test methods will be validated and documented.

The sophistication of production equipment and processes, combined with the outstanding capacities of our quality control lab, together with the excellent administration, assure our customers batch to batch consistency and inherent product integrity. For quality control, we are using DATACOLOR, MACBETH and MINOLTA for colorants, HPLC and GC for most fine chemicals, specialty chemicals and intermediates. Modern labs and professional teams of R & D keep LongChem marching ahead in technology and business of custom chemicals.

Photos of QC lab:
              

Warehouse Inspection:

We have a logistic team to perform the warehouse inspection of cargo loading into container for each shipment at the loading port; any cargo with any compromise of package and shipping marks will be hold for immediate corrections. Correction Record will be kept for future investigation. Photos of loading process and conditions of shipment will be taken and kept in archive.
All shipments will be palletized and shrink-wrapped according to international standards, or as per special customer requirements.

Photos: