Q4B Annex 5: Disintegration Test General Chapter

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions
Annex 5(R1)
Disintegration Test General Chapter
Guidance for Industry
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
September 2017
ICH
Revision 1

Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions
Annex 5(R1)
Disintegration Test General Chapter
Guidance for Industry
Additional copies are available from:
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Email: ocod@fda.hhs.gov
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
September 2017
ICH
Revision 1

TABLE OF CONTENTS
I. 	INTRODUCTION (1) ....................................................................................................... 1
II. 	Q4B OUTCOME (2) ......................................................................................................... 2
A. 	Analytical Procedures (2.1) ........................................................................................................... 2
B. 	Acceptance Criteria (2.2)............................................................................................................... 2
III. 	TIMING OF ANNEX IMPLEMENTATION (3) .......................................................... 2
IV. 	CONSIDERATIONS FOR IMPLEMENTATION (4) .................................................. 2
A. 	General Consideration (4.1) .......................................................................................................... 2
B. 	FDA Consideration (4.2) ............................................................................................................... 3
C. 	EU Consideration (4.3) .................................................................................................................. 3
D. 	MHLW Consideration (4.4) .......................................................................................................... 3
E. 	Canada Consideration (4.5) .......................................................................................................... 3
V. 	REFERENCES USED FOR THE Q4B EVALUATION (5) ........................................ 3

Contains Nonbinding Recommendations
1
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions
Annex 5(R1)
Disintegration Test General Chapter
Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the
title page.
I. 	INTRODUCTION (1)2
This annex is one in a series of guidance documents that describe the evaluations and
recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts
to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH
regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry.
For general information on the Q4B process, the reader is referred to the core guidance Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.3
This annex is the result of the Q4B process for Disintegration Test General Chapter. The
proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). This revision,
Q4B Annex 5(R1), adds the Health Canada interchangeability statement in section IV.E (4.5).
1 This guidance was developed within the Expert Working Group (Quality) of the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, and
has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has
been endorsed by the ICH Steering Committee at Step 4 of the ICH process, September 2010. At Step 4 of the
process, the final draft is recommended for adoption to the regulatory agencies.
2 Arabic numbers reflect the organizational breakdown of the document endorsed by the ICH Steering Committee at
Step 4 of the ICH process, September 2010.
3We update guidance documents periodically. To make sure you have the most recent version of a guidance, check
the FDA Drugs guidance page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm or the FDA Biologics guidance page at
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

Contains Nonbinding Recommendations
2
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. 	Q4B OUTCOME (2)
A. 	Analytical Procedures (2.1)
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group
(EWG), recommends that for tablets and capsules, the official pharmacopoeial texts, Ph. Eur.
2.9.1. Disintegration of Tablets and Capsules, JP 6.09 Disintegration Test, and USP <701>
Disintegration, can be used as interchangeable in the ICH regions subject to the conditions
detailed below. Testing conditions for specific dosage forms are outside the scope of the
harmonization of this chapter.
1. (2.1.1) For tablets and capsules larger than 18 millimeters long for which a different
apparatus is used, the Disintegration Test is not considered to be interchangeable in the
three regions.
2. (2.1.2) The Disintegration Test is not considered to be interchangeable in the three
regions for dosage forms referred to in the regional compendia as delayed-release,
gastro-resistant, or enteric-coated.
3. (2.1.3) Product-specific parameters such as media and the use of discs should be
specified in the application dossier.
B. 	Acceptance Criteria (2.2)
Acceptance criteria are outside the scope of the harmonization of this chapter and should be
specified in the application dossier.
III. 	TIMING OF ANNEX IMPLEMENTATION (3)
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.
IV. 	CONSIDERATIONS FOR IMPLEMENTATION (4)
A. 	General Consideration (4.1)

Contains Nonbinding Recommendations
3
When sponsors or manufacturers change their existing methods to the implemented Q4B-
evaluated pharmacopoeial texts that are referenced in section II.A (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.
B. 	FDA Consideration (4.2)
Based on the recommendation above, and with reference to the conditions set forth in this annex,
the pharmacopoeial texts referenced in section II.A (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.
C. 	EU Consideration (4.3)
For the European Union (EU), the monographs of the Ph. Eur. have mandatory applicability.
Regulatory authorities can accept the reference in a marketing authorization application, renewal,
or variation application citing the use of the corresponding text from another pharmacopoeia as
referenced in section II.A (2.1), in accordance with the conditions set out in this annex, as
fulfilling the requirements for compliance with the Ph. Eur. Chapter 2.9.1. on the basis of the
declaration of interchangeability made above.
D. 	MHLW Consideration (4.4)
The pharmacopoeial texts referenced in section II.A (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.
E. 	Canada Consideration (4.5)
In Canada, any of the pharmacopoeial texts cited in section II.A (2.1) of this annex and used in
accordance with the conditions set out in this annex can be considered interchangeable.
V. 	REFERENCES USED FOR THE Q4B EVALUATION (5)
A. (5.1) The PDG Stage 5B sign-off document (Rev. 1): Japanese Pharmacopoeial
Forum, Volume 16, number 4 (December 2007).
B. (5.2) The pharmacopoeial references for Disintegration Test General Chapter for this
annex are:
1. (5.2.1) European Pharmacopoeia (Ph. Eur.): Supplement 6.3 (official January
2009) Disintegration of Tablets and Capsules (reference 01/2009: 20901).

Contains Nonbinding Recommendations
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2. (5.2.2) Japanese Pharmacopoeia (JP): 6.09 Disintegration Test as it appeared in
the partial revision of the JP 15th edition (made official March 31, 2009, by the
Ministry of Health, Labour and Welfare Ministerial Notification No. 190).
3. (5.2.3) United States Pharmacopeia (USP): 	Revision Bulletin <701>
Disintegration issued June 6, 2008, and official August 1, 2008.