Q3C (R6) Step 5 - impurities: guideline for residual solvents









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218848 Q3C (R6) Step 5 - impurities: guideline for residual solvents

Temporary visiting address Spark building ł Orlyplein 24 ł 1043 DP Amsterdam ł The Netherlands

For deliveries refer to www.ema.europa.eu/how-to-find-us

An agency of the European Union Send us a question via www.ema.europa.eu/contacts Telephone +31(0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

9 August 2019

EMA/CHMP/ICH/82260/2006

Committee for Human Medicinal Products

ICH guideline Q3C (R6) on impurities: guideline for residual solvents

Step 5

Adopted by CHMP for release for consultation 23 July 2015

Start of public consultation 4 August 2015

End of consultation (deadline for comments) 3 November 2015

Final adoption by CHMP 15 December 2016

Date for coming into effect 14 June 2017

ICH guideline Q3C (R6) on impurities: guideline for residual solvents

EMA/CHMP/ICH/82260/2006 Page 2/39

Document History

Code History Date

Parent Guideline: Impurities: Guideline for Residual Solvents Q3C Approval by the Steering Committee under Step 2 and release for public consultation.

6 November 1996

Q3C Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.

17 July 1997

Revision of the PDE information for THF contained in the Parent Guideline

Q3C(R1)

Note: Prior

to adding the revision to the parent

Guideline in

November

2005, the

code was

Q3C(M) for

THF. Permissible Daily Exposure (PDE) for Tetrahydrofuran (THF): revision of PDE based on new toxicological data.

Approval by the Steering Committee of the new PDE

for THF under Step 2 and release for public consultation.

20 July 2000

Q3C(R1)

Note: Prior

to adding the revision to the parent

Guideline in

November

2005, the

code was

Q3C(M) for

THF. Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.

12 September

2002
ICH guideline Q3C (R6) on impurities: guideline for residual solvents

EMA/CHMP/ICH/82260/2006 Page 3/39

Revision of PDE information for NMP contained in the Parent Guideline

Q3C(R2)

Note: Prior

to adding the revision to the parent

Guideline in

November

2005, the

code was

Q3C(M) for

NMP.

Permissible Daily Exposure (PDE) for N-

Methylpyrrolidone (NMP): revision of PDE based on

new toxicological data. Approval by the Steering Committee of the Revision under Step 2 and release for public consultation.

Temporary visiting address Spark building ł Orlyplein 24 ł 1043 DP Amsterdam ł The Netherlands

For deliveries refer to www.ema.europa.eu/how-to-find-us

An agency of the European Union Send us a question via www.ema.europa.eu/contacts Telephone +31(0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

9 August 2019

EMA/CHMP/ICH/82260/2006

Committee for Human Medicinal Products

ICH guideline Q3C (R6) on impurities: guideline for residual solvents

Step 5

Adopted by CHMP for release for consultation 23 July 2015

Start of public consultation 4 August 2015

End of consultation (deadline for comments) 3 November 2015

Final adoption by CHMP 15 December 2016

Date for coming into effect 14 June 2017

ICH guideline Q3C (R6) on impurities: guideline for residual solvents

EMA/CHMP/ICH/82260/2006 Page 2/39

Document History

Code History Date

Parent Guideline: Impurities: Guideline for Residual Solvents Q3C Approval by the Steering Committee under Step 2 and release for public consultation.

6 November 1996

Q3C Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.

17 July 1997

Revision of the PDE information for THF contained in the Parent Guideline

Q3C(R1)

Note: Prior

to adding the revision to the parent

Guideline in

November

2005, the

code was

Q3C(M) for

THF. Permissible Daily Exposure (PDE) for Tetrahydrofuran (THF): revision of PDE based on new toxicological data.

Approval by the Steering Committee of the new PDE

for THF under Step 2 and release for public consultation.

20 July 2000

Q3C(R1)

Note: Prior

to adding the revision to the parent

Guideline in

November

2005, the

code was

Q3C(M) for

THF. Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.

12 September

2002
ICH guideline Q3C (R6) on impurities: guideline for residual solvents

EMA/CHMP/ICH/82260/2006 Page 3/39

Revision of PDE information for NMP contained in the Parent Guideline

Q3C(R2)

Note: Prior

to adding the revision to the parent

Guideline in

November

2005, the

code was

Q3C(M) for

NMP.

Permissible Daily Exposure (PDE) for N-

Methylpyrrolidone (NMP): revision of PDE based on

new toxicological data. Approval by the Steering Committee of the Revision under Step 2 and release for public consultation.
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