Q4B Annex 11 Step 4

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH HARMONISED TRIPARTITE GUIDELINE
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

TEXTS FOR USE IN THE ICH REGIONS
ON
CAPILLARY ELECTROPHORESIS GENERAL CHAPTER
Q4B ANNEX 11
Current Step 4 Version

dated 9 June 2010
This Guideline has been developed by the appropriate ICH Expert Working Group and
has been subject to consultation by the regulatory parties, in accordance with the ICH
Process. At Step 4 of the Process the final draft is recommended for adoption to the
regulatory bodies of the European Union, Japan and USA.
Q4B Annex 11
Document History
Code History Date
Q4B Annex 11 Approval by the Steering Committee under Step 2 and 29 October
release for public consultation. 2009
Current Step 4 version
Q4B Annex 11 Approval by the Steering Committee under Step 4 and 9 June 2010
recommendation for adoption to the three ICH regulatory
bodies.
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS
FOR USE IN THE ICH REGIONS
ON
Q4B Annex 11
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 9 June 2010, this guideline is recommended for
adoption to the three regulatory parties to ICH
TABLE OF CONTENTS
1. INTRODUCTION ..........................................................................................................1
2. Q4B OUTCOME .............................................................................................................1
2.1 Analytical Procedures .....................................................................................................1
2.2 Acceptance Criteria .........................................................................................................1
3. TIMING OF ANNEX IMPLEMENTATION .........................................................1
4. CONSIDERATIONS FOR IMPLEMENTATION ...............................................1
4.1 General Consideration....................................................................................................1
4.2 FDA Consideration ..........................................................................................................1
4.3 EU Consideration ............................................................................................................2
4.4 MHLW Consideration .....................................................................................................2
4.5 Health Canada Consideration ......................................................................................2
5. REFERENCES USED FOR THE Q4B EVALUATION ...................................2
i
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR
USE IN THE ICH REGIONS
ON
Q4B ANNEX 11
1. INTRODUCTION
This annex is the result of the Q4B process for the Capillary Electrophoresis General
Chapter.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
2. Q4B OUTCOME
2.1 Analytical Procedures

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group
(EWG), recommends that the analytical procedures described in the official pharmacopoeial
texts, Ph.Eur. 2.2.47. Capillary Electrophoresis, JP General Information 4. Capillary
Electrophoresis, and USP General Information Chapter <1053> Biotechnology-derived
Articles – Capillary Electrophoresis,1 can be used as interchangeable in the ICH regions.
2.2 Acceptance Criteria
The texts evaluated did not contain acceptance criteria.
3. TIMING OF ANNEX IMPLEMENTATION

When this annex is implemented (incorporated into the regulatory process at ICH Step 5) in
a region, it can be used in that region. Timing might differ for each region.
4. CONSIDERATIONS FOR IMPLEMENTATION
4.1 General Consideration

When sponsors or manufacturers change their existing methods to the implemented Q4B-
evaluated pharmacopoeial texts that are referenced in Section 2.1 of this annex, any change
notification, variation, and/or prior approval procedures should be handled in accordance
with established regional regulatory mechanisms pertaining to compendial changes.
4.2 FDA Consideration
Based on the recommendation above, and with reference to the conditions set forth in this
annex, the pharmacopoeial texts referenced in Section 2.1 of this annex can be considered
interchangeable. However, FDA might request that a company demonstrate that the chosen
1 The harmonized text under review has been incorporated into USP informational chapter <1053>
Biotechnology-derived Articles – Capillary Electrophoresis, which is official (as of the July 1, 2009,
USP Revision Bulletin). The USP proposed in Pharmacopeial Forum (Vol. 36, number 1) to drop the
existing (mandatory) General Chapter <727> Capillary Electrophoresis (also now official), and
rename the (nonmandatory) chapter <1053> to Capillary Electrophoresis. The official date for this
change will be May 1, 2011 (USP 34-NF29).
1
Capillary Electrophoresis General Chapter
method is acceptable and suitable for a specific material or product, irrespective of the
origin of the method.
4.3 EU Consideration
For the European Union, regulatory authorities can accept the reference in a marketing
authorisation application, renewal or variation application citing the use of the
corresponding text from another pharmacopoeia as referenced in Section 2.1, in accordance
with the conditions set out in this annex, as fulfilling the requirements for compliance with
the Ph. Eur. Chapter 2.2.47. on the basis of the declaration of interchangeability made
above.
4.4 MHLW Consideration
The pharmacopoeial texts referenced in Section 2.1 of this annex can be used as
interchangeable in accordance with the conditions set out in this annex. Details of
implementation requirements will be provided in the notification by MHLW when this
annex is implemented.
4.5 Health Canada Consideration
In Canada any of the pharmacopoeial texts cited in Section 2.1 of this annex and used in
accordance with the conditions set out in this annex can be considered interchangeable.
5. REFERENCES USED FOR THE Q4B EVALUATION

5.1 The PDG Stage 5B sign-off document: Japanese Pharmacopoeial Forum, Volume 11, number 4
(October 2002).
5.2 The pharmacopoeial references for Capillary Electrophoresis General Chapter for this
annex are:
5.2.1 European Pharmacopoeia (Ph. Eur.): Supplement 6.6 (published June 2009, and
official January 1, 2010), Capillary Electrophoresis (reference 01/2008:20247);
5.2.2 Japanese Pharmacopoeia (JP): General Information 4. as it appears in the JP
Fifteenth Edition (March 31, 2006, The Ministry of Health, Labour and Welfare
Ministerial Notification No. 285). The English text was officially updated by
errata published by MHLW at
http://www.std.pmda.go.jp/jpPUB/Data/ENG/jpdata/H201105_jp15_errata.pdf on
May 28, 2010;
5.2.3 United States Pharmacopeia (USP): 2 <1053> Biotechnology-derived Articles –
Capillary Electrophoresis, USP Revision Bulletin posted May 29, 2009, official
July 1, 2009.
2 See footnote 1

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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL

REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED TRIPARTITE GUIDELINE

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

Current Step 4 Version

Code History Date

Current Step 4 version

2.1 Analytical Procedures

3. TIMING OF ANNEX IMPLEMENTATION

4. CONSIDERATIONS FOR IMPLEMENTATION

4.1 General Consideration

5. REFERENCES USED FOR THE Q4B EVALUATION

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