Approved technique operation regulation and SOP

Record the whole production process accurately and precisely in writing and assure each and every batch can be traced.

Unqualified products must be approved by the QA review and approval before they are sent back for reprocessing.

All the deviation in data must be processed according to SOP.

Implement strictly the Batch Management Regulations to ensure product quality consistence and reliability.

Facility and equipment design and quality must meet all technical requirements to ensure the quality of products.

Clean equipments for every production, document and mark after cleaning process.

All instruments should be validated by qualified institution and with appropriate mark.

Specification, standard, sampling procedures must be approved by QA

Investigate the cause of any mistake, record and correct it accordingly.

Accelerated and normal sample stability tests

Take care of customer’s complaints on quality, transportation, packaging and after-sales service in a timely manner.

Strictly manage and control raw materials and finished products to maintain dynamic balance.

Products must come from qualified suppliers and tested by QC before used in any production.

Unqualified intermediates must be stopped and can’t be used in the following production process.

Products must be inspected by QC and audited by QA to assure no deviation.

Returned goods must be treated according to returned goods management procedures and the same batch quality should be reviewed

Select qualified suppliers and standard package according to statutory standards.

Destroy and record under the supervision of QA

Consistent with stability test and statutory standards to ensure product stability and uniformity.