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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
TEXTS FOR USE IN THE ICH REGIONS ON
RESIDUE ON IGNITION/SULPHATED ASH GENERAL CHAPTER
Q4B ANNEX 1(R1)

Current Step 4 version
dated 27 September 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.


1(R1)
Q4B Annex 1(R1)
Document History
Code *

History

Date

Q4B Annex 1

Approval by the Steering Committee under Step 2 and
release for public consultation.

8 June 2006

Q4B Annex 1

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

1 November
2007

Current Step 4 version
Q4B Annex 1(R1) Integration of the Health Canada Interchangeability
Statement under Section 4.5 after approval by the
Steering Committee.

*

27 September
2010

Code as per the new codification system adopted by the ICH Steering Committee
in November 2007


VALUATION
EVALUATION AND RECOMMENDATION OF
PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS
ON

ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 1 November 2007, this guideline is recommended for
adoption to the three regulatory parties to ICH

(This annex was revised -R1- to include the Interchangeability Statement from Health
Canada on September 27, 2010)

TABLE OF CONTENTS

1.

.......................................................................................................
................................................................
INTRODUCTION ....................................................................................................... 1

2.

OUTCOME................................................................................................
..........................................................................................................
Q4B OUTCOME.......................................................................................................... 1

2.1

Analytical Procedures..................................................................................................... 1

2.2

Acceptance Criteria ........................................................................................................ 1

3.

IMPLEMENTATION ................................................................
TIMING OF ANNEX IMPLEMENTATION ................................................................ 1

4.

FOR
........................................................
CONSIDERATIONS FOR IMPLEMENTATION ........................................................ 1

5.

...............................................
REFERENCES USED FOR THE Q4B EVALUATION ............................................... 2

i


EVALUATION AND RECOMMENDATION OF
PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS
ON

1.

INTRODUCTION

This annex is the result of the Q4B process for Residue on Ignition/Sulphated Ash.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
2.

Q4B OUTCOME

Procedures
2.1
Analytical Procedures
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working
Group (EWG), recommends that the official pharmacopoeial texts, Ph.Eur. 20414
Sulphated Ash, JP 2.44 Residue on Ignition Test, and USP <281> Residue on Ignition
can be used as interchangeable in the ICH regions given the following:
2.1.1

Unless otherwise specified in a monograph, an appropriate sample
weight is chosen, typically 1-2 g, to result in a level of residue sufficient
to be accurately measurable by weight (typically 1 mg). If not specified
in the monograph, the appropriate sample weight should be justified,
and the sample weight and the acceptance criteria should be specified
in the application dossier.

2.1.2

The muffle furnace should be appropriately calibrated to ensure
compliance with regional GMP requirements.

2.2
Acceptance Criteria
The proposed 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 may 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 in accordance
with 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
method is acceptable and suitable for a specific material or product,
irrespective of the origin of the method.

1


4.3

EU consideration: For the European Union, the monographs of the Ph. Eur.
have mandatory applicability. 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,
Sulphated Ash: 20414, 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

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 14, Number 4 (December 2005). (Note: the PDG cover letter
published in this volume was subsequently changed based on Q4B comments.)

5.2

The pharmacopoeial references for Residue on Ignition/Sulphated Ash for this
annex are:
5.2.1

European Pharmacopoeia (Ph. Eur.): Supplement 5.6 (official on
January 2007) (reference Sulphated Ash 01/2007:20414);

5.2.2

Japanese Pharmacopoeia (JP): 2.44 Residue on Ignition Test as it
appears in the JP Fifteenth Edition (March 31, 2006, The Ministry of
Health, Labour and Welfare Ministerial Notification No. 285);

5.2.3

United States Pharmacopeia (USP): <281> Residue on Ignition official
in USP 29, 2nd Supplement, August 2006.

2

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