Regulatory Aspects of Impurities in Biological Products - IIR

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Question 1 Is the nature and source of the impurity known? Have sensitive and broad detection methods been used to discover impurities? Yes- go to question 2 No Demonstrate your impurity screening methods are not insensitive and/or have narrow vision Categorize the nature and source of the impurity Process-Related, Product-Related, Contaminant Inorganic, organic, biochemical, microbiological, physical Cell substrate, cell culture, down-stream, adventitious
Question 2 Can you measure the amount of the impurity with appropriate sensitivity, accuracy and precision? Yes – go to Question 3 No Develop an appropriate method and monitor the impurity at appropriate process points
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: Process-Related Impurity Decision T
Page 17 and 18: Is the impurity qualified by toxico
Page 19 and 20: Question 6 Is the level of the impu
Page 21 and 22: Process Consistency Major component

Regulatory Aspects of Impurities in Biological Products - IIR

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