GB/T 28671-2012
ActiveGuidelines for pharmaceutical machinery validation
制药机械（设备）验证导则
Application Summary AI generated
This standard provides guidelines for validating pharmaceutical machinery and equipment used in the production of drugs, ensuring they meet design, installation, operational, and performance specifications. It is applied by pharmaceutical manufacturers and equipment suppliers in China during the qualification and process validation stages of solid, liquid, and semi-solid dosage form production. The standard helps ensure compliance with Good Manufacturing Practice (GMP) requirements by establishing a systematic framework for testing and documenting equipment reliability.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.