Regulatory Aspects of Impurities in Biological Products - IIR

More documents

Recommendations

Info

Q6B Defines Contaminants Adventitious Agents Mycoplasma Bacteria Viruses Prions* Entotoxins and pyrogens Inactivation and/or clearance for safety
Q6B Suggests a Specifications Design Record for Impurities Identify the impurity Measure the impurity with suitable test methods Assess safety risks of the impurity Design the process to be capable of clearing or at least reducing impurities of concern Characterize / validate the process to understand and demonstrate critical process parameters that yield impurity control for the product Submit impurity specifications that reflect an understanding of impurity risk and process capability to produce a product with safe impurity 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: Q6B Defines Product-Related Impurit
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 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

Create successful ePaper yourself

Delete template?

Save as template?