Regulatory Aspects of Impurities in Biological Products - IIR

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Question 5 Is the level of the impurity throughout the process known? Yes – Question 6 No Measure the impurity at appropriate process points Determine the reproducibility at the appropriate process points Is the stability of the impurity impacted by different process variables? Adjust approach based on data.
Question 6 Is the level of the impurity below the qualified safety level? Yes – Question 7 No – Improve the process to reduce the impurity to acceptable levels
Page 1 and 2: Regulatory Aspects of Impurities in
Page 3 and 4: Where It Is Written FDA has no spec
Page 5 and 6: ICH Q6B Overview Specifications; Te
Page 7 and 8: Q6B Defines Product-Related Substan
Page 9 and 10: Q6B Defines Product-Related Impurit
Page 11 and 12: Q6B Suggests a Specifications Desig
Page 13 and 14: Process-Related Impurity Decision T
Page 15 and 16: Question 2 Can you measure the amou
Page 17: Is the impurity qualified by toxico
Page 21 and 22: Process Consistency Major component

Regulatory Aspects of Impurities in Biological Products - IIR

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