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Documentation Approved technical rules and post SOP Record True, accurate, and each batch of the production process can be traced back Rework&Reprocess Unqualified products must be approved by the QA review and rework & re-processing Deviation Management Production process and data in accordance with procedures in case of deviation Batch Management The final mixed product for the same batch number to ensure product quality stability, uniform

F&E design Material, size, grade have been reasonably designed, will not affect the product quality Clean Before each shift to ensure equipment clean and pollution-free and have clearly marked Check All instruments, meters, units are by qualification and a clear identity check

Standards and Procedures Specifications，standards, sampling procedures and test procedures approved by QA OOS Investigation Detailed survey and record the causes and correction of errors Stability Testing Accelerated testing and conventional stability test samples remain Complaints Handing Handling customer's complaints for quality, transportation, packaging and after-sales service and other

Inventory Control Management and control on materials, finished products such as the, to maintain homeostasis Material Handing Audited suppliers, products released after passing inspection by QC can be put into use Control Intermediate Unqualified products do not flow into the next process Product Release After be tested and qualified by the QC,and QA unbiased review,products can be released Return Goods Managment Handling return product according to management procedures and trace the status of batch product quality

Produce and Release Produce by statutory standards and grant by Program,to ensure quality and no loss Rejected Product Management Under the supervision's QA,rejected product is destroyed of the count and record Expiry Dating Consistent with stability test data and statutory standards to ensure product stability, uniformity

美天生物

QUALITY SYSTEM