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QUALITY

According to the requirements of customers in the worldwide and the demand of products ,we have written the QC brochure and relevant procedure files to audit the QC system for all colleagues and whole production procedure. Our company keeps improving the management concept and has established the QC matured research and production. Basing on the continual technology innovation, matured research and technologies will be provided to meet the quality demand of our Customs.

As always ,our company is dedicated to :

-Insist on service innovation ,pursue full satisfaction and excellent experience of our customers

-Insist on technology innovation and keep developing the quality of products and service

We have analysis instrument include NMR ,GC-MS ,LC-MS ,KF,GC,HPLC,IR and Polarimeter etc .in our Lab.

QUALITY ASSURANCE

Activities and Responsibilities:

  • Release of qualification and validation protocols;
  • Release of documents: specifications; Master Batch Records, SOPs;
  • Batch reviewing and releasing, archiving;
  • Release of batch records;
  • Change control, deviation control, investigations;
  • Approval of validation protocols;
  • Training;
  • Internal audits, compliance;
  • Supplier qualification and supplier audits;
  • Claims, recalls, etc.

QUALITY CONTROL

In our laboratories and workshops, we provide quality analysis and inspection though the control of the whole process to make sure every single batch of our product meets the requirements from our customer.

Activities and Responsibilities:

  • Development and approval of specifications;
  • Sampling, analytical check and release of raw materials, intermediates and cleaning samples;
  • Sampling, analytical check and approval of APIs and finished products;
  • Release of APIs and final products;
  • Qualification and maintenance of equipment;
  • Method transfer and validation;
  • Approval of documents: analytical procedures, SOPs;
  • Stability tests;
  • Stress tests.