The Rongsheng pharmaceutical production plant at Chengdu in China's Sichuan province has entered into the digital age. The contract signed in June 2011 between Chengdu Rongsheng Pharmaceutical Co. and Siemens has been successfully completed. It covered the different phases of implementing a Manufacturing Execution System (MES) at the Rongsheng Chengdu plant.

Compliance with FDA Requirements

After the implementation and successful go-live of phase I in December 2012, and of phase II in September 2013, the MES system was used in parallel with the paper-based flows and systems, in compliance with FDA requirements for GMP (Good Manufacturing Practices), until August 14. Starting in August 2014, the MES now ensures exclusively electronic operations and FDA 21 CRF Part 11 compliant workflows with electronic records and electronic signatures.

The project covers the entire blood products factory of Rongsheng, including production planning, equipment status management, process monitoring and manufacturing declaration of finished goods to the warehouse. It meets GMP regulations in terms of production procedure standardization and lean manufacturing management. It also supports strict control requirements of effective production procedure in compliance with GMP specifications. Over 50 work orders and 1,000 tasks are carried out on a daily basis.

Implementation of Siemens Industry Software

In order to ensure smooth implementation, the project was split up into two stages. The implementation includes completely integrating the data at the PCS layer with the ERP layer, as well as real-time communication. The result is a three-layer structure of automation, MES and ERP, the foundation of the digital factory.

The project strictly follows GMP requirements. Implementation and validation of the entire project are completed in compliance with GAMP5 guidelines through a collaboration between different Rongsheng teams (QA, manufacturing, IT) and the Siemens Industry Software organization in China and France. All aspects and steps of the implementation from the Unique Requirement Specification, Functional Specification, Design Specification, to Factory Acceptance Test, Site Acceptance Test to Installation Qualification and Operational Qualification, were meticulously carried out, carefully following validation guidelines.

Improving GMP Production Quality

For the purpose of patient safety, pharmaceutical quality assurance, and data integrity, the project encompasses real-time electronic batch records, electronic signature, batch design, execution and review by exception, full audit trail and genealogy. It ensures that there is no cross-contamination between batches. Further, it ensures that only equipment that meets the requirements in terms of sterilization or cleaning and calibration is used. The MES system controls the release of production quality parameters. It also releases production schedules and plans, and controls the expiry date, accuracy and genealogy of materials. It significantly decreases risks due to manual operations in the production process and improves production compliance through strict process control, the use of electronic instructions and bar code technology.