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Hualan Bio Vaccine Production Quality Management System—Enactment of Chinese new GMP and Promotion o

Hualan Biological Bacterin Co., Ltd. founded in Oct.2005, Adhering to construction concept of a high starting and high standard, the company's plant design and equipment import connected with the international advanced level. The company built the production plants, testing centers, animal centers, and related production auxiliary plants and other infrastructure according with GMP requirements. Now Hualan Bio has four vaccine products on market, including Seasonal Inactivated Influenza Vaccine (Split virion); Influenza A (H1N1) Vaccine, (Split, Inactivated); Meningococcal Polysaccharide Vaccine Group ACYW135; Recombinant Hepatitis B Vaccine (Hansenula polymorpha). Market share of leading product was in the first place in Chinese vaccine industry. Statistical data of SFDA showed that market share of Hualan Inactivated Influenza Vaccine (Split virion) reached 22% of the total influenza vaccine in China, was the first place. In 2009 outbreak of Influenza A (H1N1), research paper about Influenza A (H1N1) Vaccine produced by Hualan Bio was published in New England Journal of Medicine on Oct. 21th, 2009, providing a timely reference for prevention and control of global Influenza A (H1N1). During this period, Hualan Bio supplied Influenza A (H1N1) Vaccine of 53 million dosages to Chinese government, accounted for 35% of stockpile of Influenza A (H1N1) Vaccine, inoculation rate reached 40% of usage amount in China. The Hualan actively participated in international cooperation, on Jul. 2011 joined in their subordinates Influenza Vaccine Supply International Task Force (IVS ITF) approved by International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), that marked the efforts and contributions for prevention and control of influenza was are recognized by the international pharmaceutical industry.
Meanwhile, Hualan Bio continued to use the Performance Excellence Model for enterprise management, and in early 2011 has passed the ISO9001 International Quality Management System, ISO14001 Environmental Management System, OHSAS18001 occupational health and safety management system certification, effective operation of the management system was Playing a positive role on the aspects of product quality, environmental protection, protecting the employees’ health and safety.
In order to make the Hualan vaccines early go abroad, 2009 Hualan Bio built the No.2 Workshop for influenza vaccine production fully reference the new GMP (expert discussion draft) and the relevant requirements of EU GMP, invited the foreign professional company to audit the design and started international certification. In the past two years, through the efforts, incorporated the consulting and guidance from foreign professional company, the quality management level has been significantly enhanced, computer system validation, production and control test, the qualification of the QC equipment and instruments, cleaning validation, validation of analysis methods and other system would be more clear.
About the construction of quality assurance system for production, risk assessment (RS) was used in the whole management system, for example in the activities cleaning validation, process validation, impact of changes, life cycle of equipment and instruments. For the methods are not included in the Chinese Pharmacopoeia, carried out the analysis method validation (AMV), implement as the Q2 requirement of ICH. Therefore, in 2010 Hualan Biological Bacterin Co., Ltd. as one of the vaccine enterprises participated in WHO evaluation for Chinese vaccine regulatory system.
On Mar. 1st 2011, Chinese new GMP was formally implemented, that would be bound to have a significant impact to improving the quality of medicines, ensuring the safety and effectiveness of public medication. Meanwhile Chinese vaccine regulatory system also has passed the WHO evaluation, this marked Chinese vaccine manufacturers can apply for WHO prequalification after passed Chinese new GMP certification. WHO vaccine prequalification is the guarantee of a specific vaccine compliance with international standard in quality, safety and effectiveness, and also is a prerequisite of manufacturers distributing the vaccine to other countries through UN Purchasing Units.
The existing GMP certificate of influenza vaccines No.2 Workshop is valid until 2015; applying for WHO prequalification must pass the Chinese new GMP, Hualan Biological Bacterin Co., Ltd. applied for the new GMP certification to SFDA in advance, influenza vaccine project can apply for WHO prequalification only after passed the new GMP.
From Jul. 31th to Aug. 3th Hualan Bio influenza vaccine accepted site inspection of new GMP by SFDA. On Oct. 9th 2011, according to the provisions of “attestation management measure of GMP” through the site inspection and audit approval, Influenza Vaccines No.2 Workshop and No.4, 5, 6 Filling Lines of No.2 Filling Section were compliance with the requirements of the new GMP, passed the GMP certification and the number were CN20110018 and CN20110016.
Biological Bacterin Co., Ltd. applied for seasonal influenza vaccines prequalification according to the procedure and requirements at WHO Head Office in Geneva, Swiss, started the WHO influenza vaccines prequalification. We would continue to enhance and improve production and quality management system, under the supports of all parties and our own efforts, more actively participated in the study, prevention and control of international influenza, contributed our power to the study, prevention and control of influenza in China and the word.
Note: International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is the global non-profit NGO representing the research-based pharmaceutical industry, its members comprise 26 leading international companies and 60 national and regional industry associations covering developed and developing countries.

Influenza Vaccine Supply International Task Force (IVS ITF) was founded in Feb. 2002 (it’s the member of IFPMA); it located in the key partners of the response to seasonal and pandemic influenza from UN and WHO. Most of the influenza vaccines world are produced by IVS members, its members related advocacy, communication, policy, regulation and technical matters of the pandemic and seasonal influenza vaccine by cooperation.