2010年6月30日星期三

HKSQ Study Mission - KUNMING Pharmaceutical Corp

Hong Kong Society for Quality (HKSQ) organized a study mission to visit KUNMING Pharmaceutical Corp. (昆明制药集团股份有限公司) on 25 June 2010.

The first study mission was a Site Visit to KUNMING Pharmaceutical Corp. to learn first hand its GMP compliant manufacturing operations.


In the beginning, Mr. Ma Weipeng (International Technical Director) introduced KUNMING Pharmaceutical Corp. (KPC) which established in March 1951. KPC is an enterprise focusing on innovative natural botanic drugs and its business scope covers Traditional Chinese Medicines (TCM), chemical medicines and medicinal circulation fields; it is integrated with R&D, production, wholesales and international marketing and sales.


KPC has started its international GMP road since 1995. KPC’s artemether workshop passed the Australian GMP authentication of TGA in October 2001 and passed GMP of WHO inspection in September 2004. Since the injection firstly passed the GMP authentication in 2002, all the following products have passed the GMP authentication of SFDA, including 9 formulations: tablets (片劑), hard capsules (硬膠囊劑), soft capsules (軟膠囊劑), granules formulation (顆粒劑), small volume injection (小容量注射劑), frozen-dried powder for injection (凍乾粉針劑), spray solution (噴霧劑), liniment (擦劑) and mixture (合劑); and 9 APIs: Artemisinin (青蒿素), Artemether (蒿甲醚), helicid (豆腐果素), colchicines (秋水仙鹼), reserpine (利血平), breviscapine (燈盞花素), acetagastrodin (乙酰天麻素), gastrodin (天麻素), panax notogiseng saponin (三七皂甙) and so on.


The core competence was shown below.


After Mr. Ma's introduction, Mr. Fung (HKSQ exco member) briefed the history and the mission of Hong Kong Society for Quality.


Then we visited the show room of KPC. In show room, all KPC products were introduced and their drug development history was mentioned.


We saw some antique of drug production equipments.


Premier Wan Jiabao visited KPC on 6 October 2004.


After the show room visit, I represented HKSQ to present souvenir to Mr. Ma.


Followed the schedule, we visited the production line of small volume injection (filled in ampoule - 注射液瓶).


Since it was in clean room area, we had changed the clean room gown.

The clean rooms were separated from 100k to 10k to 100 for different process.


After that we went to the department of quality for visiting their laboratories including Raw Material Test Lab, Balance Room, Drying Lab, Sample Preparation Lab, IR Analysis Lab, HPLC & GC Lab, UV Lab, Incubating Room, Injection Dosage Test Lab, Sterility Test Lab, etc.


We visited Sterilization Room.


Then we had a lunch with Ms. Yu Zelin (Director – International Business), Ms. Gu Leixu (Director of Aministration) and Ms. J.Y. Cha (Manager).

Finished the first study mission, we brought some Tea leaf and Panax (三七/田七).


Panax


Panax was grinded to be powder.


We had dinner in this restaurant in that night.


For more information:
KUNMING Pharmaceutical Corp. (昆明制药集团股份有限公司)Please visit http://www.kpc.com.cn/list.asp?KindId=0501

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