]

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............................................................................................................................. 1
1. ...................................................................................................................................... 2
2. ..................................................................................................................... 2
2.1. ................................................................................................................... 2
2.2. .................................................................................... 2
2.3. .............................................................................................................. 3
3. ............................................................................................................................ 3
3.1. ........................................................................................................ 3
3.2. ............................................................................................ 3
3.3. ................................................................................. 3
4. ...................................................................................... 4
4.1. ........................................................................................................................ 4
4.2. ................................................................................. 4
4.3. ........................................................................................................ 4
4.4. ........................................................................................................ 5
4.5. ...................................................................................................................... 5
5. ................................................................................................................................ 5
6. ....................................................................................................................... 6
6.1. ............................................................................................................................. 6
6.2. ............................................................................................................ 6
6.3. ........................................................................................................ 7
6.4. ...................................................................................................... 7
6.5. ....................................................................... 8
6.6. ......................................................................................................... 8
7. ............................................................................................... 8
7.1. ......................................................................... 8
7.2. 2012-2013 ............................................................... 8
7.3. .............................................................................................. 8
7.4. .............................................................................................. 8
8. ....................................................................................................... 8
9. .............................................................. 8
10. .............................................................................................. 9
11. ............................................................................................................. 9
12. ............................................................................................................................................ 9
13. ................................................................................................................................. 9
....................................................................................................................................... 10

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1.

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2.
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[User Requirement Specification]

[Design Qualification]

[Installation Qualification]

[Operational Qualification]

[Performance Qualification]

[Process Validation]

Quality Risk Management Programms

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6.
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6.5.
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12.

13.
13.1. WHO/PHARM/93.562 «Good Manufacturing Practices for Pharmaceutical Products – Annex
«Guidelines on the Validation of Manufacturing Processes»
13.2. 2001/83/ «Community code relating to medicinal products for human use»
13.3. «The Rules Governing Medicinal Products, Volume IV Guide to Good Manufacturing
Practice for Medicinal Products» (2008)
13.4. Current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR, PART 211)
13.5. «Guideline on General Principles of Process Validation» (1987)
13.6. «PIC/S recommendation PI 006-1» (2001)
13.7. GAMP Guide for Validation of Computerized Systems in Pharmaceutical Manufacture
(Version 5.0,2009)
13.8. Guide FDA to Inspection of Foreign Pharmaceutical Manufacturers
13.9. Guide FDA to Inspection of Oral Sterile and Nonsterile products - Pre/Post Approval Issues
for Development and Validation
13.10. Guide FDA to Inspection of High Purity Water Systems
13.11. Guide FDA to Inspection of Validation of Cleaning Processes
13.12. Technical monograph PDA (Parenteral Drug Association) No. 1 «Validation of Steam
Sterilization Cycles»
13.13. Technical monograph PDA No.3 «Validation of Dry Heat Processes Used for Sterilization and
Depyrogenation»
13.14. Technical monograph PDA No. 13 «Fundamentals of a Microbiological Environmental
Monitoring Program»

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13.15. Technical monograph PDA No. 22 «Process Simulation Testing for Aseptically Filled
Products»
13.16. Technical monograph PDA No. 23 «Industry Survey on Current Sterile Filtration Practices»
13.17. Technical monograph PDA No. 26 «Sterilizing Filtration of Liquids»
13.18. Technical monograph PDA No. 27 «Pharmaceutical Package Integrity»
13.19. Recommendations IES-RP-CC013 «Equipment Calibration and Validation Procedures»
13.20. ISPE Baseline Guides, Volume 5 «Commissioning and Qualification» (2001)
13.21. ISO 2859-1 «Sampling procedures for inspection by attributes; Part 1: Sampling plans indexed
by acceptance quality level (AQL) for sub-batch-by-sub-batch inspection»
13.22. ISO 11134 «Sterilization of health care products - Requirements for validation and routine
control - Industrial moist heat sterilization»
13.23. ISO 11135 «Medical devices - Validation and routine control of ethylene oxide sterilization»
13.24. ISI/IEC 12207 «Information technology - Software life cycle processes»
13.25. ISO 13408 «Aseptic processing of health care product»
13.26. ISO 14644 «Clean rooms and associated controlled environments»

1 04 2012.02.04

2 02 2011.09.12

3 01 2009.02.25

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