We focus on developing and custom manufacturing of pharmaceutical starting raw materials and GMP intermediates under ISO and cGMP practice.
 

GMP SYSTEM
We have established a GMP documentation system to ensure the quality, covering the following but not least to those:

      Documentation and Records Management Systems
      Company Training Policy and SOPs
      Deviations and error management control
      Change Control
      Internal Audit
      Product Complaints
      Corrective and Preventive Action
      Product Release
      Supplier Approval/Qualification
      Master and Batch production record
      Master and batch test record
      Process and test method validation
      Impurity profile justification and risk management
 

We have dedicated QA team to qualify suppliers and to be qualified, dedicated QC team 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 documented; They will be validated per customer’s request.

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 involve HPLC, GC, UV, IR, MS, NMR for fine chemicals, specialty chemicals, intermediates and APIs. Our 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.