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Process Validation

The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. ¹¤ÒÕÑéÖ¤£ºÖ¤Ã÷Ôڹ涨µÄ²ÎÊý·¶Î§ÄÚ²Ù×÷¾ù¿ÉÒÔÓÐЧµØºÍÖظ´ÐÔµØÉú²ú³ö·ûºÏÔ¤¶¨ÖÊÁ¿±ê×¼ºÍÖÊÁ¿ÊôÐԵIJúÆ·µÄÎļþ¡£ Product realisation

Achievement of a product with the quality attributes to meet the needs of patients, health care professionals and regulatory authorities and internal customer requirements. (ICH Q10)

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Validation carried out before routine production of products intended for sale. Ç°ÑéÖ¤£ºÔڼƻ®ÓÃÓÚÉÏÊÐÏúÊ۵ij£¹æ»¯Éú²ú֮ǰ½øÐеÄÑéÖ¤»î¶¯¡£ Quality by design

A systematic approach that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.

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A systematic process for the assessment, control, communication and review of risks to quality across the lifecycle. (ICH Q9)

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A material that closely approximates the physical and, where practical, the chemical characteristics, e.g. viscosity, particle size, pH etc., of the product under validation.

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A condition in which the set of controls consistently provides assurance of acceptable process performance and product quality.

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Traditional approach

A product development approach where set points and operating ranges for process parameters are defined to ensure reproducibility.

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A product development approach where set points and operating ranges for process parameters are defined to ensure reproducibility.

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User requirements Specification (URS)

The set of owner, user and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system. Óû§ÐèÇó˵Ã÷£¨URS£©£ºÓÉËùÓÐÕß¡¢Ê¹ÓÃÕßÒÔ¼°±ØÒªÇÒ³ä×ãµÄ¹¤³ÌÈËÔ±×é³É£¬Îª·ûºÏϵͳԤÆÚÄ¿µÄ¶ø½øÐеĿÉÐÐÐÔÉè¼Æ¡£

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