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1. EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev 1. Guideline on pro-

cess validation for finished products information and data to be provided in
regulatory submissions, 27 February 2014.
2. 42-3.5:2004. . .
/ . , . , . . ,
, 2004. VI + 12 .
3. CPMP/QWP/848/96 and EMEA/CVMP/598/99. Note for Guidance on
Process Validation. London, 1 March 2001.
4. CPMP/QWP/2054/03 and EMEA/CVMP/395/03. Annex II to Note for
Guidance on Process Validation CPMP/QWP/848/99 EMEA/CVMP/598/99.
Non-Standard Processes. London, 10 August 2004.
5. 1.5-2003. . ,
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6. - 42-1.0:2005. .
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32 .
8. Directive 2001/83/EC of the European Parliament and of the Council of 6
November 2001 on the Community code relating to medicinal products for human use
9. EMEA/CHMP/167068/2004 (ICH Topic Q8). Part I: Note for Guidance
on Pharmaceutical Development. Part II: Annex to Note for Guidance on Pharma-
ceutical Development, June 2009.
10. - 42-3.0:2011. .
(ICH Q8) / . , . , .
. , , 2012. VIII + 28 .
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January 2011.
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(ICH Q9) / . , . , . .
, , 2012. VIII + 22 .
13. EMA/INS/GMP/79818/2011. Pharmaceutical Quality System (ICH
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23
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