The aseptic process guarantee technical exchange meeting ended successfully

On January 11, 2017, aseptic process assurance technology exchange meeting was successfully concluded in Zhangjiang High Tech Park, Shanghai The two-day meeting, jointly organized by China food and drug international exchange center and sartorius China, attracted more than 160 representatives from Shanghai drug review and verification center and national biopharmaceutical field Dr Rene Faber, global vice president of filtration technology of Sartorius Group, opened the meeting He showed the update of relevant pharmaceutical laws and regulations at home and abroad in recent years, and mentioned that with the increasing application of disposable technology in various aspects of biological processes, the requirements for the compliance of disposable products are increasingly strict As a pioneer of disposable technology, sartorius has always been committed to providing comprehensive disposable products and technical support for biological processes from research and development to production, helping in-process drugs enter the market faster, while reducing costs and efficient production, so as to improve the market competitiveness of pharmaceutical enterprises Ms Zhang Hua, deputy director and chief certifier of Shanghai drug review and verification center, delivered a speech on "sterile process defects and improvement opinions" Director Zhang introduced the main problems found in GMP inspection in recent years, and put forward corresponding improvement and improvement suggestions from three aspects: "deepen the understanding of products and processes", "improve the ability of quality risk management" and "improve the operation of quality management system" At the same time, she also elaborated the prospect and thinking of the future from the aspects of aseptic drug production, parameter release and advanced manufacturing technology Dr Christian boecking, senior manager of validation project in Asia Pacific region of Sartorius Group, delivered a speech entitled "FDA's regulatory perspective in validation of sterilization and filtration process" He first introduced all kinds of laws and regulations that pharmaceutical enterprises relied on in process validation in detail, and stressed that before process validation, it is necessary to combine the in-depth understanding of process, products and regulatory requirements to accurately judge the validation content, so as to achieve twice the result with half the effort By sharing real cases, he showed some common problems in the validation work of pharmaceutical enterprises, and emphasized the importance of modern pharmaceutical thinking, quality risk management and the application of quality system throughout the process Mr Chai Haiyi, an expert in Pharmaceutical Microbiology, delivered a speech entitled "environmental monitoring - quality control of culture medium" He pointed out that false negative is always the biggest risk of environmental microorganism monitoring, and the reason for false negative is mainly caused by the applicability of environmental monitoring methods and the applicability test of environmental monitoring medium Because some unconventional operations in environmental monitoring applicability test may also promote the growth of microorganisms, it is clearly stipulated in Chinese Pharmacopoeia, USP and FDA that the pollution rate should be evaluated in the process of culture or pre culture Ulrich BR, Asia Pacific Marketing Director of filtration technology, Sartorius Group? Mr utigam delivered a speech entitled "quality assurance in filtration applications and new filtration technologies" He shared how sartorius strictly implemented quality control in the filter production process, including membrane production, quality tracking inspection of membrane manufacturing process, strict training of production personnel, etc At the same time, the innovative filtration membrane technology is introduced, which involves innovative fold mode, seam technology, process parameter monitoring and other aspects Mr Yu Ji, director of biopharmaceutical production of Haizheng Pharmaceutical Co., Ltd shared with you "Application of simulated filling of culture medium in biopharmaceutical process" He introduced the definition and requirements of culture medium simulation in domestic and foreign regulatory guidelines, and showed the application of culture medium simulation in vaccines and recombinant vaccines, blood products and biochemical drugs, recombinant proteins and antibodies and other biological products in combination with the technological process At the same time, the important points for attention in the process of medium simulation were shared, including the control of the preconditions and the worst conditions of medium simulation, as well as the control of some interference activities Dr Isabelle uettwiller, head of validation laboratory in France of Sartorius Group, shared with you "industry standards and compliance practices for extractable / leachable substances" She gave a detailed introduction to extractables and leachables, and shared the regulatory update of international regulations on extractables and leachables USP and ASTM have drafted relevant guidance documents for extractable and leachable substances, and relevant chapters of USP have made clear requirements for validation process conditions and risk assessment The extractive guidelines provided by sartorius are comprehensive, covering component performance identification, physicochemical and biocompatibility testing and extractive research in compliance with regulatory requirements, while sartorius' consistency? The validation service will conduct risk assessment based on regulatory requirements and industry standards, and extract data under specific components and process conditions will be used for market authorization and regulatory purposes Ms Petra motzkau, director of validation services in Asia Pacific region of sadolis group, shared the "contents of GMP aseptic drug appendix in the EU revision" Ms Petra pointed out that regulators had been looking forward to developing compliance documents based on risk management, combined with industry expert advice, in order to balance compliance, cost and product quality, patient safety She proposed that many amendments would be issued in 2017, such as Appendix 1 of the European GMP guidelines on the production of sterile drugs, and elaborated on various aspects of the risk assessment trend focusing on the sterilization grade filter, and how these aspects affect the use of the filter in the production process In the end, she shared with you how to view the development history of risk management and specific process guidance from the perspective of European GMP guidelines Mr Shi Jianhua, R & D director of truking Huatong Pharmaceutical Equipment Co., Ltd., shared "two preparation processes and comparative analysis of water for injection" Mr Shi showed the composition of the pharmaceutical water system and shared the requirements of USP, EP and CHP for water for injection He pointed out that the essence of maintaining the quality of pharmaceutical water system is to control the microbial load and particle load in the pharmaceutical production process through the quality derived from the design concept Zhuansunyan, deputy director of GMP Department of Shanghai drug evaluation and verification center, shared the "Introduction to GMP inspection of sterile drugs in Shanghai" Vice Minister zhuansun first presented the results of GMP inspection in Shanghai in the past year, and at the same time analyzed the causes of major defects, including deviation management, change control, confirmation and verification, production management, microbial control, environmental monitoring and CO production Mr Wang Dongming, quality director of Roche pharmaceutical China, shared the "reliability (DI) analysis of data related to pharmaceutical production process equipment" The presentation mainly introduces the overview of Di, the evaluation and risk management of Di based on case analysis, and the importance of di He pointed out that di management runs through the whole product life cycle, involving the complete supply chain of drugs from suppliers to internal production and operation, and then to the final customers, so it is very important to do a good job in di management He pointed out that at present, there are many problems in di management of enterprises, both inside and outside the industry At the same time, he expounded the judgment system, risk control points and data management methods (paper data and electronic data) of Di evaluation Mr Cui Tiemin, process director of Shenzhen Langrun biopharmaceutical Co., Ltd., delivered a speech on "it's better to discuss the verification work sooner rather than later" He showed the misunderstandings and problems about validation in the production process of pharmaceutical enterprises, and combined with the definition and requirements of laws and regulations, explained that the essence of process validation is to validate products, control strategies of processes and control capabilities of processes, so the control strategies of products and processes are the basis of process validation Validation work needs to run through the whole life cycle of drugs from "inspection control quality", "production quality stage" to "design quality stage" By understanding the internal and external requirements of verification, the concept of QBD is effectively applied in the process of process design Finally, he pointed out that enterprises need to pay attention to compliance and quality, carry out validation work as early as possible, and try to avoid the loss caused by the delay of sales caused by drug quality problems Mr Shen Liang, China regulatory affairs manager of sedolis, shared the "risk assessment and process validation of disposable system application" He pointed out that disposable technology has been widely used in drug packaging materials, medical devices and pharmaceutical process equipment, and the production cost savings of pharmaceutical enterprises have also promoted the promotion of disposable technology At first, he described the application guidance of domestic and foreign regulations and industry standards on disposable system, and at the same time, he made in-depth discussion on "how to identify and assess the risk of SUS application in pharmaceutical process according to regulatory requirements" and "how to manage and evaluate the process validation of SUS suppliers".