The validation of pharmaceutical production is a systematic review and documentation process that ensures that all manufacturing processes, equipment and systems in the production of drugs (British English: medicinal products) function predictably, reliably and in accordance with established standards and specifications (translation into German: Spezifikationen).

The purpose of validation (German: Validierung) of pharmaceutical manufacturing is to ensure that the manufacturing processes are stable, monitored and deliver consistently high-quality products. This is a critical process in the pharmaceutical industry as the quality and safety of drugs has a direct impact on patient health.

The validation process in pharmaceutical production includes the following main stages:

• Validation planning: Identification of all production processes, systems, equipment and parameters to be validated. A validation plan is drawn up and tasks, resources and schedules are defined.
• Qualification of systems and devices: This is the first step of validation, where the systems and devices used in the production processes are tested and qualified to ensure that everything works properly and meets the requirements.
• Process and parameter setting: Determining the ideal parameters for production processes that guarantee consistent product quality. Acceptable limits and specifications are defined for all stages of production.
• Execution of validation protocols: Testing and monitoring all production processes, devices and systems to ensure that they fulfil the specified standards and requirements.
• Analysis and documentation of the results: Analysis of the data obtained (German translation: Daten) and documentation of the validation results. All validation stages must be documented.
• Validation approval: Validation approval is granted based on the results and documentation. If all requirements are met, the process or system is considered validated.
• Maintenance and regular re-evaluation: After successful validation, the processes and systems should be regularly maintained and re-evaluated to ensure their stability and reliability in the long term.

Validation of pharmaceutical production is mandatory to fulfill the standards of Good Manufacturing Practice (GMP) (German: Gute Herstellungspraxis) and other legal requirements. This ensures a high level of product quality and protects the health of patients. Validation can also prevent potential problems and non-conformities in manufacturing processes.

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