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- (European Medicines Agency) ICH: EMEA/CHMP/167068/2004 ICH. Part I: Note for Guidance on Pharmaceuti-cal Development (ICH Topic Q 8 (R2) Pharmaceutical Development). Part II: Annex to Note for Guidance on Pharmaceutical Development (ICH Topic Q 8

Annex Pharmaceutical Development), June 2009

(EMEA/CHMP/167068/2004 ICH. I: - (ICH Topic Q 8 (R2) ). II: (ICH Topic Q 8 ), 2009)

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. ................................................................................... V .................................................................................... 1 ............................................................................... 2 .................................................................. 3 .............................................................................. 5 I. ............................. 6 1. ............................................................................................... 6

1.1. ............................................................................... 6 1.2. ....................................................................... 6

2. ....................................................................... 6 2.1. ............................................. 8

2.1.1. ............................................................. 8 2.1.2. ........................................................... 9

2.2. ...................................................................... 9 2.2.1. ................................................................... 9 2.2.2. ............................................................................. 10 2.2.3. - .......................... 10

2.3. .................................................... 11 2.4. / .............................. 12 2.5. ......................................................... 13 2.6. ....................................................................................... 13

II. ....... 14 1. ............................................................................................... 14 2. .................................................... 15

2.1. ............................................. 16 2.2. ........................................................... 16 2.3. : (CQAs) ..................................................................

17 2.4. ..................................................... 17

2.4.1. ................................................................ 17 2.4.2. ....................................................................

18

2.4.3. () ..... 18 2.4.4. ................................................

18

2.4.5. .......................................

19

2.4.6. ..... 19 2.5. ........................................................................ 19 2.6. ............................................................................................

21

- 42-3.0:2011

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3. (CTD) ...........................................................................................................

21 3.1. ...................................................................................................

22

3.2. ...................................................... 22 3.3. ........................................................................ 22 3.4. ......................................... 22

1 ........................... 23 2 ............................................................ 25 ......................................................... 31

- 42-3.0:2011

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( en) - (European Medicines Agen-cy) EMEA/CHMP/167068/2004 ICH. Part I: Note for Guidance on Pharma-ceutical Development (ICH Topic Q 8 (R2) Pharmaceutical Development). Part II: Annex to Note for Guidance on Pharmaceutical Development (ICH Topic Q 8

Annex Pharmaceutical Development), June 2009 (EMEA/CHMP/167068/2004 ICH. I: (ICH Topic Q 8 (R2) ). II: (ICH Topic Q 8 -), 2009) [1,2].

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, . . EMEA/CHMP/167068/2004 ICH () CPMP/QWP/155/96 Note for Guidance on Development Pharmaceutics ( - ) CPMP/QWP/054/98 Decision Trees for the Selection of Sterilisation Methods. Annex to Note for Guidance on Development Pharmaceu-

tics (CPMP/QWP/155/98) ( . (CPMP/QWP/155/98) [3,4]. EMEA/CHMP/167068/2004 ICH [1,2]. - 42-3.1:2004 . -. [5], -: CPMP/QWP/155/96 CPMP/QWP/054/98 [3,4]. - , 42-3.1:2004 [5].

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-, EMEA/CHMP/167068/2004 ICH. Part I: Note for Guidance on Pharmaceutical Development (ICH Topic Q 8 (R2) Pharma-

ceutical Development). Part II: Annex to Note for Guidance on Pharmaceutical Development (ICH Topic Q 8 Annex Pharmaceutical Development) [1,2].

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(ICH Q8)

(ICH Q8)

MEDICINAL PRODUCTS

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: . . 2001 . . . 1. 2004 . . . 2. 2008 . . . 3. 2009 . . . 4. 20011 . 42-3.2:2004 . . -

: - 42-4.0:2011 . 42-4.2:2011 . -

(ICH Q9) - 42-4.3:2011 .

(ICH Q10) European Pharmacopoeia. 7

th Edition. European Directorate for the Quality of

Medicines (EDQM). Council of Europe, 67075 Strasbourg Cedex, France 2010 PMP/ICH/365/96 (ICH Topic Q6) Note for Guidance on Specifications:

Test Procedures and Acceptance Criteria for Biotechnological/Biological roducts, 1999

/ICH/367/96 (ICH Topic Q6A) Note for Guidance Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug

Products: Chemical Substances, 2000

/ICH/2887/99 (ICH Topic 4) Common Technical Document for the Registration of Pharmaceuticals for Human Use: Organisation of Common Tech-

nical Document, 2004

/ICH/2887/99 Quality (ICH Topic 4 Q) Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality Overall

Summary of Module 2 and Module 3: Quality, 2003

/ICH/2887/99 Safety (ICH Topic 4 S) Common Technical Docu-ment for the Registration of Pharmaceuticals for Human Use: Nonclinical Oberview

and Nonclinical Summaries of Module 2 and Organisation of Module 4, 2003

/ICH/2887/99 Efficacy (ICH Topic 4 E) Common Technical Document for the Registration of Pharmaceuticals for Human Use: Clinical ober-

view and Clinical summary of Module 2 and Module 5: Study reports, 2003

CPMP/EWP/QWP/1401/98 Guideline on the Investigation of Bioequiva-

lence, 2010 EudraLex. The Rules Governing Medicinal Products in the European Un-

ion. Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Prod-ucts for Human and Veterinary Use

http://ec.europa.eu/health/documents/eudralex/vol-4/index en.htm

EMA/INS/GMP/79766/2011 Quality Risk Management (ICH Q9), 2011

EMA/INS/GMP/79818/2011 Pharmaceutical Quality System (ICH Q10), 2011

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CPMP CHMP

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CTD Common Technical Document ( -)

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FMEA failure mode effects analysis ( ) GMP good manufacturing practice ( ) ICH International Conference on Harmonisation of Technical Re-

quirements for Registration of Pharmaceuticals for Human Use

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- 42-3.0:2011

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- 42-3.0:2011

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/ICH/367/96 (ICH Topic Q6A) Note for Guidance Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug

Products: Chemical Substances 42-3.2:2004 . . -

: -

N, PMP/ICH/365/96 (ICH Topic Q6) Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotech-nological/Biological roducts1.

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- 42-3.0:2011

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- 42-3.0:2011

26

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. Initial Moisture Content (IMC) . Mean Particle Size . Temperature (Temp) .

- 42-3.0:2011

27

. 1:

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- 42-3.0:2011

28

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29

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- 42-3.0:2011

30

3: - / . 1-2 %. , - .

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- 42-3.0:2011

31

()

1. EMEA/H/167068/2004 ICH. Part I. ICH Topic Q 8 (R2). Step 5: Note for Guidance on Pharmaceutical Development, 2009

2. Annex to EMEA/H/167068/2004 ICH. Part II. ICH Topic Q 8 Annex. Step 5: Annex to Note for Guidance on Pharmaceutical Development (EMEA/H/167068/2004), 2009

3. CPMP/QWP/155/96. Note for Guidance on Development Pharmaceu-tics, 1998

4. CPMP/QWP/054/98 Corr. Decision Trees for the Selection of Sterilisa-tion Methods. Annex to Note for Guidance on Development Pharmaceutics

(CPMP/QWP/155/96), 2000

5. 42-3.1:2004. . . - / . , . , . . , , 2004

6. 1.5-2003. . , , / . , . , . , . . , , 2003

7. - 42-1.0:2005. . . / . , . , . . , , 2005

8. 1.7-2001. . - / . , . , . . , , 2003

9. CPMP/ICH/2736/99 (ICH Topic Q1A (R2)) Note for Guidance on Stabil-

ity Testing: Stability Testing of New Drug Substances and Products, 2003

10. 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 hu-

man use. L 311, 28.11.2001. P. 67-128 11. 42-4.2:2011. .

(ICH Q9) / . , . , . . , , 2011

12. - 42-4.0:2011. . / . , . , . . , , 2011

13. Doc. Ref. EMEA/P/24143/2004. Procedure for European Union guide-lines and related documents within pharmaceutical legislative framework, 2005

14. /ICH/367/96 (ICH Topic Q6A) Note for Guidance Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug

Products: Chemical Substances, 2000

- 42-3.0:2011

32

15. 42-3.2:2004 . . -:

16. 42-4.3:2011. . (ICH Q10) / . , . , . . , , 2011

17. EudraLex. The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

http://ec.europa.eu/health/documents/eudralex/vol-4/index en.htm

18. EMA/INS/GMP/79766/2011. Quality Risk Management (ICH Q9), 2011

19. EMA/INS/GMP/79818/2011. Pharmaceutical Quality System (ICH Q10), 2011

20. EMEA/CHMP/CVMP/QWP/17760/2009 Rev 1 (Draft). Guideline on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Da-

ta Requirements for New Submissions and Variations, 2009

- 42-3.0:2011

33

: , , , , ( ), - , , , - / , , , , , , - .

_ 42_3.0_2011_1 _ 42_3.0_2011_2

Documents

42 3-0-2011 Farmacevtichna Rozrobka