Impractically of risk-based approach to establish quality of pharmaceutical products and/or their manufacturing

In general to apply risk-based approach to establish quality of anything one would require a defined and measurable outcome/parameter. Once such an outcome/parameter is known or established then it is used to reflect chances of achieving success or failure of manufacturing or producing quality products. If the defined outcome/parameter is not available then it would not be possible to use risk-based approach for such. The manufacturing of the quality pharmaceutical products falls in this category i.e. there is no define parameter/outcome available for a “quality product”, thus risk-based assessment approach in pharmaceutical manufacturing is not possible at present.
To apply risk-based approach one would require to define quality pharmaceutical product with a measurable parameter. So, please seek a definition of a “quality pharmaceutical product” along with its measurable parameters using qualified and validated scientific methods. As an example please see here (

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