Miroslav Pavlov SOPHARMA JSCo

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???????

• Miroslav Pavlov SOPHARMA JSCo
• 2008-09-08

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• USP lt61gt, lt62gt, lt1111gt
• Pharm Eur 2.6.12, 2.6.13, 5.1.4
• JP ?????????????? ??????????

PDG Pharmacopoeial Discussion Group
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• USP ? ???? ?? 01/05/2009
• lt61gt Microbiological Examination Of Nonsterile
  Products Microbial Enumeration Tests
• lt62gt Microbiological Examination of Nonsterile
  Products Tests for Specified Microorganisms
• lt1111gt Microbiological Quality of Nonsterile
  Pharmaceutical Products
• www.usp.org/USPNF/notices/postponementHarmonMicrob
  iology.html
• EP - ? ???? ?? 01/01/2009
• 2.6.12 Microbiological Examination Of Nonsterile
  Products Microbial Enumeration Tests
• 2.6.13 Microbiological Examination of Nonsterile
  Products Tests for Specified Microorganisms
• 5.1.4 Microbiological Quality of Nonsterile
  Pharmaceutical Products
• www.emea.europa.eu/Inspections/QWPfaq.html

4
ICH International Conference on Harmonization

• GUIDELINES
• Evaluation and recommendation of pharmacopoeial
  texts for use in the ICH regions on
  Microbiological Examination of Non-sterile
  products Microbial Enumeration Tests general
  chapter Q4B Annex 4A
• The ICH Steering Committee, based on the
  evaluation by the Q4B Expert Working Group (EWG),
  recommends that the official pharmacopoeial
  texts, Ph.Eur. 2.6.12. Microbiological
  Examination of Non-Sterile Products Microbial
  Enumeration Tests, JP 4.05 Microbiological
  Examination of Non-Sterile Products I.
  Microbiological Examination of Non-Sterile
  Products Microbial Enumeration Tests, and USP
  lt61gt Microbiological Examination of Nonsterile
  Products Microbial Enumeration Tests can be used
  as interchangeable in the ICH regions.

5
ICH International Conference on Harmonization

• Evaluation and recommendation of pharmacopoeial
  texts for use in the ICH regions on
  Microbiological Examination of Non-sterile
  products Test for Specified Micro-organisms
  general chapter Q4B Annex 4B
• The ICH Steering Committee, based on the
  evaluation by the Q4B Expert Working Group (EWG),
  recommends that the official pharmacopoeial
  texts, Ph.Eur. 2.6.13. Microbiological
  Examination of Non-Sterile Products Tests for
  Specified Micro-organisms, JP 4.05
  Microbiological Examination of Non-Sterile
  Products II. Microbiological Examination of
  Non-Sterile Products Tests for Specified
  Micro-organisms, and USP lt62gt Microbiological
  Examination of Non-Sterile Products Tests for
  Specified Micro-organisms can be used as
  interchangeable in the ICH regions

6
ICH International Conference on Harmonization

• Evaluation and recommendation of pharmacopoeial
  texts for use in the ICH regions on
  Microbiological Examination of Non-sterile
  products Acceptance Criteria for Pharmaceutical
  Preparations and Substances for pharmaceutical
  Use general chapter Q4B Annex 4C
• The ICH Steering Committee, based on the
  evaluation by the Q4B Expert Working Group (EWG),
  recommends that the official pharmacopoeial
  texts, Ph.Eur. 5.1.4. Microbiological Quality of
  Non-Sterile Pharmaceutical Preparations and
  Substances for Pharmaceutical Use, JP General
  Information 12. Microbial Attributes of
  Nonsterile Pharmaceutical Products, and USP
  lt1111gt Microbiological Attributes of Non-sterile
  Pharmaceutical Products can be used as
  interchangeable in the ICH regions.

7
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• ?? ?? ?? ?????? ??????? ? ????????? ????????? ?
  ?????????????? ??, ???, ??????
• (???????????? ?? ? ???????? ?? ????????? ?
  ?????????? ?? ?????????? ????, ??????? ????
  ??????????, ???????? ?????)

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? ???? ?? 01/ 01/ 2009

• www.emea.europa.eu/Inspections/QWPfaq.html
• ???? ??????????? ?? 31/12/2008 ????????? ? ??
  ?? ??????? ? ????????????????? ?????? ?? ??, ??
  ?? ?????????? ?? ?? ????????? ???????????????
• ???? ??????????? ???? 01/01/2009 ?? ?? ???????
  ???? ??????????????? ??????

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• ????????? ?????????

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• ?????????? ????? (Pour Plate)

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• ?????????? ????? (Pour Plate)

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• ????????????, ???????, ????? (Spread Plate)

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?????? ????? (control)
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????????????? ? ?????????????? ?? ?? ??????
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• ?????? ?? ????? ?????????????? ?? 01/01/2009
• ??????????????? ?????? ?? ?????????? ?? ?????? ??
  ?????????? ? ????? ? ?? ? ?????????? ??????????
  ?? ???????? ? ???? ?? ?????????????????

24
??????????

• The Harmonization Of The Microbial Limits Test
  Enumeration, Scott Sutton, Vectech
  Pharmaceutical Consultants
• EMEA
• ICH Gudelines Evaluation And Recommendation Of
  Pharmacopoeial Texts For Use In The ICH Regions
  On Microbiological Examination Of Non-sterile
  Products Q4B Annex 4A, 4B, 4C
• USP lt61gt, lt62gt, lt1111gt
• Pharm. Eur. 2.6.12, 2.6.13, 5.1.4

25
??????????

• 8. ICH Guideline Evaluation And Recommendation
  Of Pharmacopoeial Texts For Use In The ICH
  Regions On Residue On Ignition/Sulphated Ash
  General Chapter Q4B Annex 1
• 9. ICH Guideline Evaluation And Recommendation
  Of Pharmacopoeial Texts For Use In The ICH
  Regions On Test For Extractable Volume Of
  Parenteral Preparations General Chapter Q4B Annex
  2
• ??? ? ??-??-014-02-06 ??? ?? ?????????? ??
  ?????????????????
• ?????? ?? ?????????
• Special Regulatory Issues For Microbiology
  Laboratories and Validation of
• Microbiological Methods, Jeanne
  Moldenhauer

26
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• ???? ????????? ?-? ???
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