We look at pharmaceutical processes over their entire lifecycle 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 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.
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.
The requirements for computerized systems in pharmaceutical manufacturing and production continue to increase. Suitability for the intended use must be documented and proven for each system. Siemens confirms compliance with the functional requirements of using electronic records and electronic signatures in the ERES Compliance Responses for different products:
Adherence to the measures of quality assurance is documented in the Manufacturer's Declaration: During the design and development of our products and systems, we follow dedicated processes and a well-defined product life cycle.
These certificates are used for the selection of products and components, but also to define specifications and validation strategies, and finally to provide evidence of compliance with regulatory requirements.
The principles of scalable lifecycle 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.
The information provided by Siemens supports the plant owner during
Especially the GMP Engineering Manual
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. With our portfolio of services and consulting over the entire system life cycle, we contribute by
The procedures we develop are based on the GAMP Guide but are also compatible with different quality system standards.
Our solutions include
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