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CMC - Micro+io"og( /Chemistr(% Manu.acturing% and Contro"s0 Chemistr(% Manu.acturing% and Contro"s /CMC0 C"inica" 1 Antimicro+ia" C"inica" 1 Medica" C"inica" *harmaco"og( Com+ination *roducts Concept *apers Current -ood Manu.acturing *ractices /C-M*s01Comp"iance !rug Sa.et( E"ectronic Su+missions !AAA / ood and !rug Administration Amendments Act0 -enerics -ood )e#ie2 *ractices Indi#idua" *roduct &ioe3ui#a"ence )ecommendations Industr( Letters Internationa" Con.erence on Harmonisation - E..icac( Internationa" Con.erence on Harmonisation - 4oint Sa.et(1E..icac( /Mu"tidiscip"inar(0 Internationa" Con.erence on Harmonisation - Qua"it( Internationa" Con.erence on Harmonisation - Sa.et( In#estigationa" 5e2 !rug App"ications La+e"ing Micro+io"og( Moderni6ation Act 7#er-the-Counter *harm 1 Tox *rocedura" Sma"" Entit( Comp"iance -uides 8ser ees

International Conference on Harmonisation - Quality

Title and Format
Q9A/):0 Sta+i"it( Testing o. 5e2 !rug Su+stances and *roducts /*! - ;<=&0 Q9& *hotosta+i"it( Testing o. 5e2 !rug Su+stances and *roducts /*! - ??@=&0

Type
Final Final

Issue Date
991:>>? 9919@@A%

Q9C Sta+i"it( Testing .or 5e2 !osage orms /*! - 9>9=&0 Q9! &racketing and Matrixing !esigns .or Sta+i"it( Testing o. 5e2 !rug Su+stances and *roducts /*! - ?9=&0 Q9E E#a"uation o. Sta+i"it( !ata /*! - ::9=&0 Q9 Sta+i"it( !ata *ackage .or )egistration App"ications in C"imatic Zones III and I$% re#ision 9 Q:/)90 $a"idation o. Ana"(tica" *rocedures: Text and Methodo"og( 5ote: In 5o#em+er :>>;% the ICH incorporated Q:& on methodo"og( 2ith the parent guidance Q:A and retit"ed the com+ined Q: documentD The contents o. the t2o guidances 2ere not re#isedD

Final Final Final Final

;1@19@@B 91:>>? A1:>>C Withdrawn B1A1:>>A

Q:A Text on $a"idation o. Ana"(tica" *rocedures /*! :;=&0 Q:& $a"idation o. Ana"(tica" *rocedures: Methodo"og( /*! - 9?:=&0

Final Final

?19@@; ;19@19@@B

Q?A/)0 Impurities in 5e2 !rug Su+stances /*! - ;;=&0 Q?&/)0 Impurities in 5e2 !rug *roducts /)e#ision :0/*! 9B9=&0 Q?C Impurities: )esidua" So"#ents /*! - C9=&0 Q?C Ta+"es and List /*! - ??=&0

Final Final Final Final

A1A1:>>< <1C1:>>A 9:1:C19@@B 9919:1:>>? :1991:>>:

Appendix C /*! - 9:>=&0E Appendix ; /*! - :9A=&0E Appendix A /*! - 9:<=&0 /Appendices 2ere issued 2ith the Q?C dra.t guidance documents0 Maintenance *rocedures .or 8pdating

Final

QC& E#a"uation and )ecommendation o. *harmacopoeia" Texts .or 8se in the Internationa" Con.erence on Harmonisation )egions /*! - ;;=&0

Final

:1:>1:>>B

Annex I: )esidue on Ignition1Su"phated Ash -enera" Chapter /*! - ?A=&0 Annex :: Test .or Extracta+"e $o"ume o. *arentera" *reparations -enera" Chapter /*! - B@=&0 Annex ?: Test .or *articu"ate Contamination: Su+#isi+"e *artic"es -enera" Chapter /*! - 9:><=&0

Final Final Final

:1:>1:>>B 91<1:>>@ 91<1:>>@

Annex CA: Micro+io"ogica" Examination o. 5on-Steri"e *roducts: Micro+ia" Enumeration Tests -enera" Chapter /*! - <9=&0 Annex C&: Micro+io"ogica" Examination o. 5on-Steri"e *roducts: Tests .or Speci.ied Micro-organisms -enera" Chapter /*! - <:=&0 Annex CC: Micro+io"ogica" Examination o. 5on-Steri"e *roducts: Acceptance Criteria .or *harmaceutica" *reparations and Su+stances .or *harmaceutica" 8se -enera" Chapter /*! - B;=&0

Final

C1B1:>>@

Annex ;: !isintegration Test -enera" Chapter /*! ?:=&0 Annex A:8ni.ormit( o. !osage 8nits -enera" Chapter /*! - <B=&0 Annex B:!isso"ution Test -enera" Chapter /*! - @?=&0 Annex <: Steri"it( Test -enera" Chapter /*! - ?:=&0 Annex @: Ta+"et ria+i"it( -enera" Chapter /*! - <C=&0 Annex 9>: *o"(acr("amide -e" E"ectrophoresis -enera" Chapter /*! - <C=&0 Annex 99: Capi""ar( E"ectrophoresis -enera" Chapter /*! - @?=&0 Annex 9:: Ana"(tica" Sie#ing -enera" Chapter /*! <<=&0 Annex 9?: &u"k !ensit( and Tapped !ensit( o. *o2ders -enera" Chapter /*! - ::;=&0 Annex 9C: &acteria" Endotoxins Test -enera" Chapter /*! - ?;:=&0

Final

9:1::1:>>@

Final

C1:1:>9>

Final Final Final Final Final Draft Draft Final

9:1::1:>>@ C1:1:>9> C1@1:>9> @1:1:>9> @191:>9> B19?1:>9> B19A1:>9> *osted @19@@<

Q;A $ira" Sa.et( E#a"uation o. &iotechno"og( *roducts !eri#ed rom Ce"" Lines o. Human or Anima" 7rigin /*! - B9=&0 Q;& Qua"it( o. &iotechno"ogica" *roducts: Ana"(sis o. the Expression Construct in Ce""s 8sed .or *roduction o. r-!5A !eri#ed *rotein *roducts /*! - 9>@=&0 Q;C Qua"it( o. &iotechno"ogica" *roducts: Sta+i"it( Testing o. &iotechno"ogica"1&io"ogica" *roducts /*! - B>=&0

Final :19@@A

Final

B19@@A

Q;! Qua"it( o. &iotechno"ogica"1&io"ogica" *roducts: !eri#ation and Characteri6ation o. Ce"" Su+strates 8sed .or *roduction o. &iotechno"ogica"1&io"ogica" *roductsE A#ai"a+i"it( /*! - ;:=&0 /Issued % *osted @1:919@@<0 Q;E Compara+i"it( o. &iotechno"ogica"1&io"ogica" *roducts Su+Fect to Changes in Their Manu.acturing *rocess /*! - ;<=&0 QAA Internationa" Con.erence on HarmonisationE -uidance on QAA Speci.ications: Test *rocedures and Acceptance Criteria .or 5e2 !rug Su+stances and 5e2 !rug *roducts: Chemica" Su+stancesD QA& Speci.ications: Test *rocedures and Acceptance Criteria .or &iotechno"ogica"1&io"ogica" *roducts /*! - AC=&0 QBA -ood Manu.acturing *ractice -uidance .or Acti#e *harmaceutica" Ingredients /*! - 9B;=&0 Note: In 5o#em+er :>>;% the ICH redesignated this guidance QBD The guidance 2as not re#isedD Q</):0 *harmaceutica" !e#e"opment /*! - C>:=&0 Q@ Qua"it( )isk Management /*! - 99?=&0 Q9> *harmaceutica" Qua"it( S(stem /*! - :BC=&0 Q<% Q@% and Q9> Questions and Ans2ers /*! - 9>B=&0 Links on this page

Final

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Final

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Final

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Final

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Final

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Final Final Final Final

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