Siemens’ solutions for the pharmaceutical industry are in line with the regulatory requirements and recommendations of the GMP regulated industry.
We look at pharmaceutical processes over their entire life cycle and beyond system boundaries. This includes products, systems, solutions and services as well as maintenance of the system during operation. In this context data integrity is one very fundamental aspect, going from entry and recording to long-term archiving of relevant data. The GAMP 5 Guide and other ISPE Good Practice Guides are part of our daily work.
Standardize processes, automate documentation, and support GMP compliance while simplifying audits and reducing risks.
Use real-time data to reduce manual effort, minimize errors, and improve decision-making across operations.
Enable monitoring, traceability, and controlled workflows to reduce deviations and ensure consistent output.
Good Manufacturing Practice (GMP) covers a range of national and international regulations and guidelines. We look at pharmaceutical processes over their entire life cycle and beyond system boundaries. This includes products, systems, solutions and services according to GAMP (Good Automated Manufacturing Practice) as well as maintenance of the system during operational phase. In this context data integrity is one very fundamental aspect, going from entry and recording to long-term archiving of relevant data.
GMP along the entire life cycle
Based on our standard product portfolio, we tailor our solutions for your needs and thus enable you to integrate a structured qualification and validation approach from the start. Following the GAMP recommendations, the regulated company and the system supplier together can build up an efficient framework. Your benefits are products, systems, and solutions, which are in line with the regulatory requirements – from sensors up to the MES.
GMP regulations
GMP regulations require that relevant components and functionalities of the system must be specified and documented. User requirements must be traceable at any time during the lifecycle of a pharmaceutical manufacturing system. We make sure that all Siemens systems and solutions for the pharmaceutical industry meet and support these requirements.
Additional guidelines provide support for the implementation, assessment and classification of computerized systems, and specify how to handle electronic records and electronic signatures in computerized systems. They give advice on topics like system validation, audit trails, user management, documentation and especially how to ensure data integrity.
Below you find the current ERES Compliance Responses and GMP Engineering Manuals.
Our portfolio enables you to comply with the guidelines for quality assurance of production processes and environments in the production of pharmaceuticals and active ingredients.
Quality by design
Central data collection to evaluate process variations
With SIPAT, enable the central data collection and real-time analysis of process and sensor data. The collected process data can be used to evaluate process variations as well as advanced process control (APC) strategies based on process models.
Powerful, flexible process and batch control system
Scalable architecture with powerful engineering tools
Our SIMATIC PCS 7 process control system combines a unique scalable architecture with powerful engineering tools and a wide variety of additional functions such as alarm management, process safety and asset management. Part of SIMATIC PCS 7 is SIMATIC BATCH, a highly flexible software package that facilitates implementing even the most complex batch processes - effectively and at reasonable costs.
Vizualization and monitoring
Modular operating and monitoring system
SIMATIC WinCC Unified system: Our modular operating and monitoring system SIMATIC WinCC facilitates the implementation of a comprehensive operating solution with a uniform audit trail and central signaling functions.
SIMATIC HMI: SIMATIC HMI operator interfaces with touch screens and stainless-steel fronts are especially designed for operator control and monitoring of processing machines in the pharmaceutical industry.
SIMATIC WinCC add-ons: Easily expand the functionality of our SIMATIC WinCC SCADA system with add-ons for quality inspection, process management as well as diagnostics and maintenance.
Paperless manufacturing
Central production management tool for smart bioprocesses
Opcenter Execution Pharma acts as a central production management tool, enabling paperless manufacturing in biopharma production. It allows for easy integration of single-use package units, supporting set-up and operation of equipment as well as the entire process through electronic work instructions and electronic batch recording (eBR).
Seamless R&D and recipe data transition –
in pharmaceutical research
With Opcenter RD&L, you will benefit from a structured, yet flexible manner to enable fast and successful drug development and time-to-market – including lab automation and electronic lab notebooks, formula and process development as well as specification and regulatory management
