Regulatory Aspects of Impurities in Biological Products - IIR

25.05.2014 • Views

Share Embed Flag

Regulatory Aspects of Impurities in Biological Products - IIR

Regulatory Aspects of Impurities in Biological Products - IIR

DOWNLOAD ePAPER

iirusa.com

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

START NOW

Q6B Def<strong>in</strong>es Product-Related Substances

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22

Managing Compliance With Your Customer Identification ... - IIR

Thorough QT Study: Design Features for Consideration - IIR

CONFERENCE GUIDE - IIR

AMLAC & Fraud - IIR

TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

Translational Medicine - IIR

The US Tax Effects Of Choice Of Entities For Foreign Investment - IIR

Achieving Optimal Tax Treatment For Private Equity Fund Of ... - IIR

Statistical Recommendations on Immunogenicity Method ... - IIR

AMLAC & Fraud - IIR

KPMG On-Screen Enhanced US - IIR

The US Tax Effects Of Choice Of Entities For Foreign Investment - IIR

Statistical Recommendations on Immunogenicity Method ... - IIR

Achieving Optimal Tax Treatment For Private Equity Fund Of ... - IIR

Q6B Recognizes the Heterogeniety <strong>of</strong> <strong>Biological</strong> <strong>Products</strong>

Q6B Def<strong>in</strong>es Product-Related Substances

Page 1 and 2: Regulatory Aspects of Impurities in
Page 3 and 4: Where It Is Written FDA has no spec
Page 5: ICH Q6B Overview Specifications; Te
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 and 20: Question 6 Is the level of the impu
Page 21 and 22: Process Consistency Major component