Regulatory Aspects of Impurities in Biological Products - IIR

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Question 3 Is the impurity generally considered safe by the industry and/or a qualified toxicologist familiar with the area? Is the impurity within published limits considering the dose and route of administration? Yes – No acceptance criteria is necessary, provided that product quality or stability is not compromised (Move to question 7) No – move to Question 4
Is the impurity qualified by toxicology, pharmacology, and safety data? Yes – Question 5 Question 4 No – Perform studies to correlate, if possible, the level of impurity with Toxicological Pharmacological effects Consider Route of administration Dose and regimen Duration Target population
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: Question 2 Can you measure the amou
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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