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Technology / Design / Food safety / Good manufacturing practice / Validation / Quality management system / Adolphe Appia / Quality control / SOP / Pharmaceutical industry / Business / Pharmaceuticals policy


20, avenue Appia – CH-1211 Geneva 27 – Switzerland – Tel central +[removed] – Fax central +[removed] – www.who.int WHO PUBLIC INSPECTION REPORT (WHOPIR) of the FPP manufacturer Part 1: General inform
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Document Date: 2014-08-08 04:35:50


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City

Geneva / Hangzhou City / Hangzhou / /

Company

WHO Inspection Report Hainan Poly Pharma / Manufacturer Hainan Poly Pharma Co. Ltd / SHARPLY Pharmaceutical Research Institute Co. Ltd. / Hainan Poly Pharma Co. Ltd / Hainan POLY Pharm / The SOP / Zhejiang POLY Pharm / WHOPIR Inspection Report Hainan Poly Pharma Co. Ltd / /

Country

Switzerland / China / /

/

Event

Product Recall / Product Issues / /

Facility

West Building / Hangzhou SHARPLY Pharmaceutical Research Institute / Jintai Commercial Building / building No2 / N/A Production Building Building / /

IndustryTerm

quality management / aseptic manufacturing steps / treatment of HIV / Quality risk management / dedicated equipment / defective products / manufacturing buildings / manufacturing practices / risk management / manufacturing site / manufacturing / Deviation management / media fills / water systems / Manufacturing processes / e.g. manufacturing / /

MedicalCondition

HIV / sterility / /

Organization

State Food and Drug Administration / World Health Organization / Manufacturer Hainan Poly Pharma Co. Ltd Unit / Quality Department / US Food and Drug Administration / /

/

Position

Quality director / General information Name / Summary General / Major / /

Product

date of inspection / mannitol / Product / products / materials / /

ProvinceOrState

Hainan Province / Zhejiang Province / Binjiang District / /

Technology

API / simulation / /

URL

www.who.int / /

SocialTag