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 / /
Country
Switzerland / China / / /
Event
Product Recall / Product Issues / /
Facility
West Building / Hangzhou SHARPLY Pharmaceutical Research Institute / Jintai Commercial Building / /
IndustryTerm
quality management / Quality risk management / defective products / manufacturing buildings / manufacturing practices / manufacturing block / risk management / manufacturing site / manufacturing / Deviation management / water systems / Manufacturing processes / e.g. manufacturing / /
Organization
State Food and Drug Administration / World Health Organization / Manufacturer Hainan Poly Pharma Co. Ltd Unit / Quality Department / US Food and Drug Administration / WHO GMPs / / /
Position
Quality director / General information Name / Summary General / Major / /
Product
date of inspection / Ganciclovir sodium / Product / products / materials / /
ProvinceOrState
Hainan Province / Zhejiang Province / Binjiang District / /
20, avenue Appia – CH-1211 Geneva 27 – Switzerland – Tel central +[removed] – Fax central +[removed] – www.who.int WHO PUBLIC INSPECTION REPORT (WHOPIR) of the API manufacturer Part 1: General inform