All for the Product Quality
August 13, 2013, the quality manager, senior manager of technical verification and stock logistics supervisor from Hisun Pfizer conducted the first quality audit to Hualan Co., Ltd. This was the second joint venture of Pfizer, U.S.A. Hualan received since Pfizer,Dalian has been in normal supply stage for one year .
Hisun Pfizer sent the audit plan to Hualan before they came to China, which indicated the purpose of the audit, members of the audit group, audit time, product for audit, schedule of the audit and etc for our company to give advice on. Hence, the audit finished successfully after one day of time-pressed but orderly cooperation. The whole day of quality audit finished quickly, though, the ideology of “all for the product quality” of Hisun Pfizer left a deep impression on the people that took part in the audit. The audit leader of Hisun Pfizer pointed out that: the purpose of GMP execution is to reduce the pollution, cross pollution and mixing, error and other risks to the largest extent during the medicine production process to ensure that products in compliance with the expected purposes and registration requirements are produced continuously and stably. GMP is the basic requirement and the enterprises should formulate all kinds of feasible standards according to the results of the product quality risk assessment, which should be executed strictly as soon as formulation and the deviance must be regulated according to the rules.
During the last audit meeting, Hisun Pfizer praised Hualan highly. They thought that the factory facilities, equipment, production process, on-site management and documentation system of Hualan were very good, all of which were in the basic compliance with Hisun Pfizer’s requirements. But since Hualan treated rubber plug production as producing medicine, they needed to raise the demand to themselves constantly.
One short day of quality audit gave us a vivid lesson on ideology transformation, which was GMP execution was neither copying others’ methods nor using what the textbooks told us to without modification, but was to formulate the appropriate standards fo the company according to the actual situation of the company products and base everything on feasibility and make sure that the product quality was guaranteed.
Wu Jianqin, manager of the quality management department of Hualan made a speech on behalf of the entire staff of Hualan in the last meeting: every little progress that Hualan made had received care and support from the nationwide medicine enterprises, especially from Pfizer Dalian, Hison Pfizer, Novartis and AstraZeneca. I’d like to take this opportunity to express our sincere gratitude. We will make good rubber plugs by the ideology of “Hualan’s products are equal to medicine, Hualan will take responsibility in safety and effect” of our company to return society.
Document audit
江苏华兰药用新材料股份有限公司 
