Regulatory Aspects of Impurities in Biological Products - IIR

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Question 7 Would the impurity pose a significant safety risk if present or does it affect the stability of the drug substance? Yes Set acceptance criteria for impurity in drug substance Base on pre-clinical and clinical safety studies and the process capability to remove Consider regulatory compendial requirements and guidance documents Establish mass balance for toxic additives No Consider setting in-process acceptance criteria or limits to ensure control of process removal If the impurity co-purifies, binds-to, or modifies the drug substance, these controls are more important
Process Consistency Major components of the impurity profile are important considerations Process-related impurities Product-related impurities Product-related substances Comparability studies also rely heavily on comparable impurity profiles
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 and 18: Is the impurity qualified by toxico
Page 19: Question 6 Is the level of the impu

Regulatory Aspects of Impurities in Biological Products - IIR

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