In the official GxP guidelines (Good x Practice, x = Laboratory, Clinical or Manufacturing, GLP, GCP, GMP) it is demanded that pharmaceutical enterprises validate their processes with influence on the product quality and the associated devices must qualify. These regulatorischen requirements apply also to computer-assisted systems (CS), which consist of hard and software.

The documented proof is furnished by validating that a process or a system fulfills the before specified requirements in the field use.

With the qualification it is documented tested that devices (hard & software), which serve for the conversion of the processes, which possess specified functionality before.

Validating in the pharmaceutical production

During validating in the pharmaceutical production at the final product it is tested whether the process always obtains under same conditions (e.g. temperature) the intended result. Again validating must be accomplished for each new product (despite identically constructed or same equipment).

For validating a validating plan is provided, after which validating is to be accomplished. The plan must fulfill the legal defaults for the production of validating plans and have the methods suggested therein with appropriate work instructions for validating to be conformal. The fact that this is the case becomes of the manufacturer, e.g. laboratory leader, control leader, manufacture leader and the quality assurance signed. For validating accomplished after this plan after execution a validating report is written, that the results and deviations documents and evaluates (looks in principle like the test report with the autoinspection, only more extensively). Only validated methods and process may be used for the production and sales by medicaments.

In the context of validating it must be also guaranteed that the used devices were qualified, and secure (reproducible) results to guarantee to be able.

Validating of automated systems

The meaning of computer-assisted systems in the pharmaceutical production increases ever more. At the same time authority and connecting with increased attention worry about appropriate Regularien and manual, which cover the requirements to systems.

The following systems must be validated:

• Enterprise guidance level:
  • ERP systems
  • Document management systems
  • Archiving systems
• Production guidance level
  • Manufacturing Execution of system (MES)
  • Laboratory information management systems (LIMS)
  • Production control systems
• Process guidance level
  • Process control systems
  • Laboratory analyzers
• Calibration software
• Other applications, in those relevant data to be stored (e.g. also Excel Spreadsheets, ACCESS data bases and other self-developments)

Proceeding for validating automated systems

The most well-known model for validating computer-assisted systems is the so-called V-model. The V-model of validating is described by GAMP (Good Automated Manufacturing Practices).

See also

• FDA
• GxP
• Procedure documentation

Related links

• http://www.fda.gov/cder/guidance/pv.htm (FDA): Food and Drugs administration, the USA.
• http://www.ispe.org/gamp/ (ISPE): Good Automated Manufacturing Practices (GAMP) for validating computer-assisted systems
• http://www.picscheme.org/ (PICS): Pharmaceutical Inspection Cooperation Scheme

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