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Our Quality Assurance System is ISO9001 certified with Quality Control Manual, Production Capacity Controlling Manual and Disaster Recovery Manual.
It also includes the documents regarding operator training requirements, records and maintenance.Plus, it includes a control process for updating all documents.
Control of Incoming Materials:
Complete records for all the incoming material suppliers;
Careful inspection on the randomly selected samples from all incoming materials;
All of the incoming materials are certified and are received with inspection data;
* No material is accepted if it doesnĄ¯t meet our quality standard.
Control of Manufacturing Process:
Statistical Process Control (SPC) to minimize process variation;
Inspections within process based on documented procedures;
A documented sample plan to monitor material quality parameters;
Strict Inspections on all the intermediates;
A documented process for disposition of our-of-specification material.
Manufacturing and Testing Equipment:
Calibration and maintenance to all of our manufacturing and testing equipments;
Calibration procedures and schedules;
Calibration records;
Maintenance procedures and maintenance records.
Product Quality:
Document of product qualification procedure;
Qualification includes final inspection, or test, or measurements according to specifications;
Available information regarding non-proprietary product qualification;
Lot number identifications with lot data documented for traceability.
Product Delivery:
Certificates of Analysis for each lot of material produced.
Customized packing standards according to material character and usage.
* Non-conforming material is not shipped without prior agreement.
 
ADD: A6th Floor,Xingcheng Building,No.176 Fazhan Street,Wuhan 430022 China
Tel: 0086 27 65681202/65681246    Fax: 0086 27 65681149
E-mail: wwch@public.wh.hb.cn / info@yipharm.com    Http://www.yipharm.com