GMP validation for quality from the start

According to the World Health Organization, the Good Manufacturing Practice (GMP) guidelines are intended to ensure that pharmaceutical products are manufactured continuously and in a controlled manner according to the specified quality standards.

GxP services for compliance right from the start

Especially in a regulated environment such as the pharmaceutical industry, the observation of Good Manufacturing Practice (GMP) rules is mandatory, and the good practices are a binding part of the validation process. The path to compliance with GxP requirements and the proof of suitability for the intended purpose starts already with the planning of a plant or system. We support you in this. With our portfolio in the areas GxP services and consulting, we contribute by

  • reducing the effort required to achieve and maintain compliance,

  • detecting and eliminating potential errors and risks early on,

  • using innovations and new technologies,

  • establishing effective processes for change and configuration management, and

  • ensuring cost-effective operation as well as efficient maintenance.

The procedures we develop are based on the GAMP 5 guidelines but are also compatible with quality system standards and other software development methods.

We offer GxP solutions and services for all lifecycle phases of computerized systems. These solutions include

  • tailored validation offerings,

  • comprehensive services within the development lifecycle,

  • the establishment of procedures and processes for regulation-compliant operation and maintenance of systems, and

  • solutions for modernization, migration, and decommissioning and data migration under GxP requirements.

Good Engineering Practice (GEP) and best practice sharing minimize effort

The principles of scalable lifecycle activities used today in validation and knowledge-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. The provided information supports the plant owner during

  • the creation of specifications for the definition of how regulatory requirements are to be implemented,

  • the determination of the complexity and novelty of components and technologies used,

  • the specification of the necessary lifecycle activities,

  • risk assessment, and

  • specification of the test strategy.

The best practice documentation

  • presents the specific requirements in the context of the relevant products,

  • serves as a guideline for component selection, and

  • supports experts during the specification of planning, validation, and acceptance criteria.

Compliance certificates for Siemens products

In August 1997, the regulations of the 21 CFR Part 11 Electronic Records; Electronic Signatures of the US Food and Drug Administration (FDA), the American regulatory and supervisory body, became effective. These regulations define the acceptance criteria for the use of electronic records and electronic signatures, which must be just as reliable and trustworthy as, and equivalent to, records in paper form and handwritten signatures on paper. From the SIMATIC distributed control system (DCS) to SIMATIC HMI/SCADA, our solutions meet all the technical requirements for the use of electronic records and electronic signatures.

The requirements for computerized systems in pharmaceutical manufacturing and production continue to increase. At the same time, suitability for the intended use must be documented and proven for each system.
Declarations of the manufacturer and declarations of conformity

  • prove that the products comply with the requirements for the storage of electronic records and electronic signatures,

  • explain compliance with additional requirements of 21 CFR Part 11 and Annex 11 of the EU Good Manufacturing Practice (GMP) guidelines, and

  • certify the compliance of the development and production of Siemens products according to our quality management system.

These certificates are used for the selection of products and components, in line with the establishment of specification and validation strategies, and to provide evidence of compliance with regulatory requirements.