A Brief Introduction:

In June 2011, Siemens signed a contract with Chengdu Rongsheng Pharmaceutical Co., Ltd. (hereinafter referred to as "Rongsheng") for the MES project at its Chengdu factory (hereinafter referred to as the "project"). Phase I of the project was successfully launched and operated in parallel in December 2012, and Phase II was successfully launched and operated in parallel at the end of September 2013. The entire MES system is expected to officially achieve independent electronic operation in August 2014 (compliant with the regulatory requirements of 21 CFR Part 11 for electronic records and electronic signatures), marking the entry of Rongsheng's production management into the digital era.

Core project requirements/pain points:

The project covers the entire blood product factory of Rongsheng, encompassing various stages from production planning, parameter standards, quality clearance, equipment status, process monitoring, to finished product warehousing. It fulfills the requirements of standardized and meticulous management in the GMP production process, supporting the company's strict control over effective production processes under GMP regulations.

Solution:

To ensure the smooth implementation of the project, it is divided into two stages. Phase I mainly focuses on the weighing, distribution and buffer preparation of materials; Phase II covers the entire production process of Rongsheng factory, including plasma input, separation, purification, ultrafiltration, semi-finished and finished product preparation, subpackaging and packaging. In addition, the project has completed the data integration and real-time communication of the underlying PCS and the upper ERP, realizing the digital factory with three-tier structure of automation, MES and ERP. The project manages more than 250 trained users, more than 50 customer terminals, more than 200 types of materials, more than 250 pieces of equipment, more than 50 work orders per day, and more than 1,000 work tasks being executed.

The project was strictly implemented in accordance with GMP requirements, and the entire implementation and verification process followed the guidance of GAMP5. It was jointly completed by Rongsheng's QA, productor, and IT, as well as the Siemens Industrial Software implementation and validation team. The implementation and verification of each step, from URS, FS, DS, FAT, SAT, to IQ, OQ, were all meticulously carried out.

Project benefits:

With the objectives of safeguarding patient safety, improving drug quality, and ensuring data integrity, the project has fully realized electronic batch records, electronic signatures, and real-time audits. It ensures the use of sterilized, cleaned, and validated equipment that meets requirements, controls the release of production quality parameters, issues production scheduling and planning tasks, and manages and controls material batches, expiration dates, weighing accuracy, and pedigree tracking and tracing. Through strict control of the technological process, computer guidance, barcode technology, and other methods, the project has greatly reduced the risk of human operation in the production process and improved production compliance.