Q4B Annex 10: Polyacrylamide Gel Electrophoresis General Chapter

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

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9/15/2017
Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions
Annex 10(R1)
Polyacrylamide Gel Electrophoresis
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 10(R1)
Polyacrylamide Gel Electrophoresis General
Chapter
Guidance for Industry
Additional copies are available from:
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Center for Drug Evaluation and Research
Food and Drug Administration
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or
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Phone: 800-835-4709 or 240-402-8010
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) ............................................................................................................... 2
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 10(R1)
Polyacrylamide Gel Electrophoresis 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 create or confer 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 the Polyacrylamide Gel Electrophoresis General
Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
This revision, Q4B Annex 10(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 the official pharmacopoeial texts, the section in Ph. Eur. 2.2.31.
Electrophoresis entitled Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDS-
PAGE), JP General Information 23. SDS-Polyacrylamide Gel Electrophoresis, and USP <1056>
Biotechnology-derived Articles – Polyacrylamide Gel Electrophoresis, can be used as
interchangeable in the ICH regions.
B. 	Acceptance Criteria (2.2)
The texts evaluated did not contain acceptance criteria.
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)
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.

Contains Nonbinding Recommendations
3
C. 	EU Consideration (4.3)
For the European Union (EU), 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 2.2.31. 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: Japanese Pharmacopoeial Forum,
Volume 9, number 1 (January 2000).
B. (5.2) The pharmacopoeial references for Polyacrylamide Gel Electrophoresis General
Chapter for this annex are:
1. (5.2.1) European Pharmacopoeia (Ph. Eur.): 	6th Edition (official in January
2008), Electrophoresis (reference 01/2008:20231).
2. (5.2.2) Japanese Pharmacopoeia (JP): The JP General Information 23. SDS-
Polyacrylamide Gel Electrophoresis as it appears in the Japanese Pharmacopoeia
Fifteenth Edition (March 31, 2006, The Ministry of Health, Labour and Welfare
Ministerial Notification No. 285).
3. (5.2.3) United States Pharmacopeia (USP): 	<1056> Biotechnology-derived
Articles – Polyacrylamide Gel Electrophoresis official in USP 32, May 1, 2009.