Good Manufacturing Practice

Siemens’ solutions for pharmaceutical industry are in line with regulatory requirements and the GAMP recommendations

Good Manufacturing Practice (GMP) validation for quality from the start

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.

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Solutions for GMP

A complete package for compliant operations

GMP refers to "Good Manufacturing Practice". Covered by different national and international regulations and guidelines, this ensures that pharmaceutical products are consistently produced according to defined quality standards.

GMP along the entire life cycle

We tailor our solutions for your needs and thus enable you to integrate a structured qualification and validation approach from the start. Your benefits are products, systems, and solutions, which are in line with regulatory requirements and the GAMP recommendations – from sensors up to the MES.

GMP regulations

GMP regulations require that every single component must be documented during the manufacturing of a pharmaceutical product and be traceable at any time. 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 signatures in computerized systems by observing criteria for systems validation, audit trails, user management, documentation and especially data integrity.

Reliability and trustworthiness matter

In Europe and the USA, relevant regulations for computer systems mainly are the EU GMP Guide Annex 11 "Computerised Systems" (1992/2011) of the European Commission and the 21 CFR Part 11 "Electronic Records; Electronic Signatures" (1997) of the US regulatory and supervisory body FDA (Food and Drug Administration). These regulations define the acceptance criteria for the use of computer systems, electronic records, and electronic signatures. These must be at least as reliable and trustworthy compared to records in paper form and handwritten signatures on paper.


Overview of Compliance Response documents

Standardized validation approach for your projects

The principles of scalable life cycle activities used today in validation and science-based quality risk management create new requirements for the planning, construction, validation, and operation of plants and systems.


The integration of the expertise of suppliers and service providers plays a significant role in this, even more significant compared to some years ago. Good Engineering Practice (GEP) belongs to the daily business of system suppliers like Good Manufacturing Practice (GMP) does for pharmaceutical companies. Therefore, good practice in different areas today is summarized as GxP, containing also laboratories, distribution, etc. We follow a standardized validation approach for the projects we execute for our clients in the pharmaceutical industry in accordance with GAMP 5.

Meet regulatory requirements of the pharmaceutical industry

Not only from planning until commissioning, but rather over the complete life cycle of your production plant we support you with worldwide know-how and expertise. Strict documentation from project management up to test execution is obligatory here to satisfy the regulatory requirements of the pharmaceutical industry.


"Good Practice" is an essential part of validation, where suitability for the intended purpose is to be proven. An integrated validation approach leads to more efficiency on the way to GxP compliant systems, as introduced by the GAMP Guide.


Everything you need for Good Manufacturing Practice

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.
SIMATIC SIPAT provides data analytics for formulation, product and process design

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.

Process and batch control at packaging pharmaceutical products: SIMATIC PCS 7

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.

Visualization and monitoring of drug production with SIMATIC WinCC Unified, SIMATIC HMI and add-ons

Visualization 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 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.

Opcenter Execution Pharma enables paperless manufacturing

Paperless manufacturing

Opcenter Execution Pharma

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).

Opcenter RD&L enables fast and successful drug development

Seamless R&D and recipe data transition

Opcenter RD&L

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.


Discover trends, news, presentations and reference projects

Learn more about our solutions for Good Manufacturing Practice (GMP) with a variety of documents, videos and downloads.


Get in touch with our experts for Good Manufacturing Practice (GMP)

Draw on our industry and technology expertise to streamline the way to better GMP compliance in your pharmaceutical operations.