GMP validation for quality from the start

GMP means “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.

Compliance statements for Siemens products

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:

  • Compliance with the requirements for the storage of electronic records and electronic signatures

  • Compliance with further requirements of 21 CFR Part 11 and Annex 11 of the EU GMP Guide

Adherence to the measures of quality assurance is documented in the Manufacturer’s Declaration:

  • 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, but also to define specifications and validation strategies, and finally to provide evidence of compliance with regulatory requirements.

GEP and Best Practice Sharing minimizes effort

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.

The information provided by Siemens 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,

  • defining the test strategy, and

  • best practice during system configuration (e.g. PCS 7 Engineering Compendium)

Especially the GMP Engineering Manual

  • presents the specific requirements in the context of the relevant product/system,

  • serves as a guideline for component selection, and

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

Compliance right from the start over the entire life cycle

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

  • 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 Guide, but are also compatible with different quality system standards.

Our 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

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