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锛?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
