Introduction：P-MEC China Summit has been celebrating its 8th anniversary since its debut in 2012. The P-MEC China Summit 2019 will focus on the four topics of ‘Solid Preparation Production Process’ , ‘Injection Production Process’, ‘Technology Transfer Verification’ and ‘Data Management’, and invite delegates from government, pharmaceutical manufacturers, and quality suppliers, to share cutting edge information of the latest technology and products.
Manufacturing Technology of Oral Solid Preparation
13:00-13:40Analysis of Problems in GMP Inspection
14:00-14:40Quality Control in Continuous Drug Production Continuous manufacturing is one of the innovative opportunities in the pharmaceutical industry. Speaker will mainly share the concept, characteristics and potential benefits of continuous manufacturing. In continuous wet granulation, for example, based on the current regulatory environment and the relevant laws and regulations and guidelines, quality/GMP, the end of the introduction of QBD approach and focus on the effect of including batch startup, shut down, control state (including product collection), in the process of sampling and the final batch release and other special circumstances, the control strategy of the continuous production to discuss how to link up existing batch production and continuous production.
Deepak Hegde GSK Shanghai R&amp;amp;amp;amp;amp;D Director-Global external Development &amp;amp;amp;amp;amp; Supply-Asiapacific
14:40-15:20Development and Quality Control of Drug Sealing System The performance of container sealing system for drug packaging is very important for drug quality protection and must be maintained in product life cycle.
Curriculum guide sealing system of medicines and relevant laws and regulations will be summarized first in the speech to clear the FDA/EMA regulators technical requirements.
Besides, the speech will discuss the sealing system design principle, sealing system supplier management and the development of quality standards and quality control, sealing system suitability test methods and sealing system change management for drugs on the market and implementation of sealing system life cycle management.
Strategies and Key Points Control of Technology Transfer and Product Transfer
10:00-10:40How to Plan and Manage Technology Transfer from R&amp;amp;amp;amp;D to Production Technology transfer in ich-q10 including the transfer of new products from the research and development stage to production and the transfer of listed products within or between production and testing sites.
Speaker will share the problems that need to be paid attention to in the transfer of new drugs from the R&D stage to commercial production based on the product nature, prescription process, facilities and equipment, materials and other aspects.
10:40-11:20New Strategy for Technology Transfer Implementation Changes in the new regulatory environment, such as the listing licensor system (MAH), consistency assessment, and data reliability, and joining ICH, present both challenges and opportunities for the institute and the pharmaceutical industry. Speaker will mainly share how to grasp these opportunities, quickly implement the product declaration and listing, enhance the core competitiveness of enterprises, and correctly implement the drug technology transfer and other very important links.
Manufacturing Technology of Injection Preparations
13:30-14:10GMP Audit (Including 483, Warning Letter, Flight Inspection Defect Project Analysis) Domestic cGMP certification has been undergoing reform, from the cancellation of certification to flight inspection, to the continuous release of inspection and observation items, all of which show that the drug regulatory authorities attach importance to the reform and determination to change. In this lecture, the guest speaker will help the senior management, production personnel, engineering equipment personnel, quality management personnel and verification management personnel to eliminate all kinds of confusion and problems in the actual work, reduce the operation of the enterprise and provide suggestions for compliance risks through the analysis of 483 warning letters and flight inspection defect projects.
10:00-10:40Computer System Verification Computerized system validation in pharmaceutical enterprises is an important part of GMP management. In this lecture, speakers will introduce how to implement application validation (software validation) and infrastructure validation (hardware validation) according to the requirements of GMP.
10:40-11:20Application Practice of Data Reliability (DI) in International and Domestic Regulatory Environment In recent years, data reliability become a hot topic of the pharmaceutical industry. National drug regulatory agencies also attaches great importance to the solution of ensuring data integrity in the process of drug production and inspection. Speaker will presents data reliability (DI) application experience based on international and domestic regulatory environment.