Who gmp certification ppt template

Good Manufacturing Practice

GMP guidelines

GMP guidelines require that every single ingredient in the manufacture of a pharmaceutical product is documented and must be traceable at all times. We ensure that all Siemens systems and solutions for the pharmaceutical industry meet these requirements.

Further guidelines provide support for the introduction, evaluation and classification of computer-aided systems and determine how electronic records and signatures in computer-aided systems are to be handled by observing criteria for system validation, audit trails, user administration, documentation and, in particular, data integrity.

The most important relevant regulations for computer systems in Europe and the USA are the GMP guidelines of the EU, Annex 11 "Computerized Systems", (1992/2011) of the European Commission and CFR Title 21 Part 11 "Electronic Records; Electronic Signatures" (1997) the US Food and Drug Administration (FDA). The acceptance criteria for the use of computer systems, electronic records and electronic signatures are specified here. These must be at least as reliable and trustworthy as paper records and handwritten signatures on paper.

Requirements for computerized systems

The requirements for computer-aided systems in pharmaceutical manufacturing and production are becoming more and more demanding. The suitability for the intended use must be documented and proven for every system. Siemens confirms the fulfillment of the functional requirements for the use of electronic records and electronic signatures in ERES declarations of conformity for various products:

  • Meeting the requirements for the storage of electronic records and electronic signatures
  • Conformity with further requirements of CFR Title 21 Part 11 and Annex 11 of the EU GMP Guide

Quality assurance measures