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Q
uali
ty G
u
id
el
i
ne
s
In November 2005, the ICH Steering
Committee adopted a new codification system
for ICH Guidelines.
The
purpose of this new codification is to ensure that
the
numbering / coding of ICH
Guidelines is more logical, consistent and
clearer.
Because the new
system applies to existing as well as new ICH
Guidelines
a history box has been added
to the beginning of all Guidelines to explain how
the
Guideline was developed and what is
the latest version.
With the new
codification revisions to an ICH Guideline are
shown as (R1), (R2),
(R3) depending on
the number of revisions. Annexes or Addenda to
Guidelines have
now been incorporated
into the core Guidelines and are indicated as
revisions to the
core Guideline (e.g.,
R1).
For implementation reasons, the
Regulatory Authorities working within the ICH
Regions (European Commission, Food and
Drug Administration and Ministry of
Health, Labor and Welfare) may not
change the codification retrospectively.
The tables below are intended to
clarify the old/new ICH Guidelines codification,
with effect November 2005.
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Stability
Previously
coded:
Q
1
A
(
R
2
)
Stability Testing of New Drug
Substances and Products
Q
1
B
Q
1
C
Q
1
D
Q
1
E
Q
1
F
Stability Testing : Photostability
Testing of New Drug
Substances and
Products
Stability Testing
for New Dosage Forms
Bracketing and Matrixing Designs for
Stability Testing of
New Drug
Substances and Products
Evaluation of Stability Data
Stability Data Package for Registration
Applications in
Climatic Zones III and
IV
Analytical
Validation
Q1A(R2)
Q1B
Q1C
Q1D
Q1E
Q1F
Q
2
(
R
1
)
New title:
Validation of Analytical Procedures:
Text and
Methodology
Q2A
Previously: Text on Validation of
Analytical Procedures
Validation of Analytical Procedures:
Methodology
(in Q2(R1))
Impurities
Q
3
A
(
R
2
)
Impurities in New Drug
Substances
Q
3
B
(
R
2
)
Impurities in New
Drug Products
Q
3<
/p>
C
(
R
3
)
Impurities:
Guideline for Residual Solvents
Impurities: Guideline for
Residual Solvents (Maintenance)
PDE for Tetrahydrofuran
(in
Q3C(R3))
PDE for
N-Methylpyrrolidone
(in
Q3C(R3))
Procedures are described
here
Pharmacopoeias
Q
4
Pharmacopoeias
Q
4
A
Pharmacopoeial Harmonisation
Q
4
B
Regulatory Acceptance of Analytical
Procedures and/or
Acceptance Criteria
(RAAPAC)
Quality
of Biotechnological Products
Q
5
A
(
R
1
)
Viral Safety Evaluation of
Biotechnology Products Derived
from
Cell Lines of Human or Animal Origin
Q
5
B
Quality of Biotechnological Products :
Analysis of the
Expression Construct in
Cells Used for Production of r-DNA
Derived Protein Products
Q
5
C
Quality of Biotechnological Products :
Stability Testing of
Biotechnological/Biological
Products
Q
5
D
Derivation and Characterisation of Cell
Substrates Used
for Production of
Biotechnological/Biological Products
Q
5
E
Comparability of
Biotechnological/Biological Products
Subject to Changes in their
Manufacturing Process
Specifications
Q
6
A
Specifications : Test Procedures and
Acceptance Criteria
for New Drug
Substances and New Drug Products:
Chemical Substances (including Decision
Trees)
Q
6
B
Specifications : Test Procedures and
Acceptance Criteria
for
Biotechnological/Biological Products
Q2B
Q3A(R)
Q3B(R)
Q3C
Q3C(M)
Q3C(M)
Q4
Q4A
Q4B
Q5A
Q5B
Q5C
Q5D
Q5E
Q6A
Q6B
Good Manufacturing Practice
Q
7
Good Manufacturing Practice Guide for
Active Pharmaceutical
Ingredients
Pharmaceutical Development
Q7A
Q
8
Pharmaceutical Development
Quality Risk
Management
Q8
Q
9
Quality Risk
Management
Q9
S
tatu
s
of
Q
u
a
l
i
ty
T
opic
s
Ask the
ICH
Secretariat
for a CD-ROM containing the
Word documents, or the
printed (A4
paper) Guidelines.
The order form
here.
(Handling costs are
charged).
Download from here the
Quality Guidelines
Q1A(R2): Stability Testing of New Drug
Substances and
Products (Second
Revision)
This guideline has
been revised a second time in order to accommodate
for the
consequences of Q1F and has
reached Step 4 of the ICH process on 6 February
2003.
This
guideline provides recommendations on stability
testing protocols including
temperature, humidity and trial
duration. Furthermore, the revised document
takes into account the requirements for
stability testing in Climatic Zones III and
IV in order to minimize the different
storage conditions for submission of a global
dossier.
Implementation
(Step 5) :
Q1A(R2)
Status :
Step 5
February 2003
EU
: Adopted by CPMP, March
2003, issued as
CPMP/ICH/2736/99
MHLW
: Adopted June 3, 2003,
PFSB/ELD Notification
No. 0603001
FDA
: Published in the
Federal Register, Vol, 68, No.
225,
Friday, November 21, 2003; pages 65717-18
Back to top
Q1B: Photostability Testing of New Drug
Substances and Products
The
tripartite harmonised ICH guideline was finalised
(Step 4) in November 1996.
This forms
an annex to the main stability guideline, and give
guidance on the basic
testing protocol
required to evaluate the light sensitivity and
stability of new drugs
and products.
Implementation (Step 5) :
Q1B
Status :
Step 5
November 1996
EU
: Adopted by CPMP,
December 96, issued as
CPMP/ICH/279/95
MHLW
: Adopted May 97,
PAB/PCD Notification No.422
FDA
: Published in the
Federal Register, Vol. 62, No. 95,
May
16, 1997, pages 27115-27122.
Back to
top
Q1C:
Stability Testing for New Dosage Forms
The tripartite harmonised ICH guideline
was finalised (Step 4) in November 1996.
It extends the main stability guideline
for new formulations of already approved
medicines and defines the circumstances
under which reduced stability data can
be accepted.
Implementation
(Step 5) :
Q1C
Status : Step 5
November
1996
EU
: Adopted by CPMP,
December 96, issued as
CPMP/ICH/280/95
MHLW
: Adopted May 97,
PAB/PCD Notification No.425
FDA
: Published in the
Federal Register, Vol. 62, No. 90,
May
9, 1997, pages 25634-25635
Back to
top
Q1D, Q1E,
Q1F
The ICH Steering
Committee agreed that the main stability guideline
should be
complemented by the following
topics : Matrixing and Bracketing (Q1D),
Statistical Analysis and Interpretation
of Data (Q1E), Data Package for
Registration in Climatic Zones III and
IV (Q1F)
Q1D: Bracketing
and Matrixing Designs for Stability Testing of
Drug
Substances and Drug
Products
The tripartite
harmonised ICH guideline was finalised (Step 4) in
February
2002. This document describes
general principles for reduced stability testing
and
provides examples of bracketing and
matrixing designs.
Implementation (Step
5) :
Q1D
Status : Step 5
February
2002
EU
: Adopted by CPMP,
Februar 2002,
CPMP/ICH/4104/00
MHLW
: Adopted on July 31,
2002 as PFSB/ELD
Notification No.
0731004
FDA
: Published in
the Federal Register, Vol 68, No. 11;
January 16, 2003; pages 2339-2340
Back to top
Q1E: Evaluation of Stability Data
The tripartite harmonised
ICH guideline was finalised (Step 4) in February
2003. This document extends the main
guideline by explaining possible situations
where extrapolation of retest
periods/shelf-lives beyond the real-time data may
be
appropriate. Furthermore, it
provides examples of statistical approaches to
stability data analysis.
Implementation (Step 5) :
Q1E
Status :
Step 5
February 2003
EU
: Adopted by CPMP, March
2003, issued as
CPMP/ICH/420/02
MHLW
: Adopted June 3, 2003,
PFSB/ELD Notification
No. 0603004
FDA
: Published in the
Federal Register / Vol. 69, N?110,
Tuesday June 8, 2004, pages 32010-32011
Back to top
Q1F: Stability Data Package for
Registration Applications in Climatic
Zones III and IV
The ICH Steering Committee
endorsed the withdrawal of the Q1F guideline
at its meeting in Yokohama, June 2006
Click here to open the Explanatory
Note
Guideline withdrawn on June 8, 2006
Q1F
Explanatory
Note
Status:
Withdrawal
EU
:
Withdrawal notification and Explanatory Note,
issued as CPMP/ICH/421/02, June 2006
MHLW
: Withdrawal adopted 3rd
July 2006, PFSB/ELD
Notification
n?0703001
FDA
: Withdrawn
from CDER's guidance page on
7/6/2006
and will be listed in the next FDA annual
guidance agenda published in the
Federal Register.
June 2006
Back to top
Q2(R1): Validation of Analytical
Procedures: Text and Methodology
The core tripartite harmonised ICH text
(previously coded Q2A) was finalised (Step
4) in October 1994. This identifies the
validation parameters needed for a variety
of analytical methods. It also
discusses the characteristics that must be
considered
during the validation of the
analytical procedures which are included as part
of
registration applications.
The addendum tripartite harmonised ICH
text (previously coded Q2B) was
finalised (Step 4) in November 1996. It
extends the guideline Q2A to include the
actual experimental data required,
along with the statistical interpretation, for the
validation of analytical procedures.
The addendum has been incorporated into
the core guideline in November 2005.
Implementation of the core guideline
(Step 5) :
Q2(R1)
Status :
Step 5
October 1994
EU
: Adopted by CPMP,
November 94, issued as
CPMP/ICH/381/95
MHLW
: Adopted July 95,
PAB/PCD Notification No.755
(core)
FDA
: Published
in the Federal Register, Vol. 60, March
1, 1995, pages 11260
(Addendum
incorporated
Implementation
status of
the Addendum (Step 5) :
in
the core guideline )
Status
:
Step 5
EU
:
Adopted by CPMP, December 96, issued as
CPMP/ICH281/95
MHLW
: Adopted October 97,
PMSB/ELD
Notification No.338
FDA
: Published in the
Federal Register, Vol. 62, No.
96, May
19, 1997, pages 27463-27467
Back to
top
November
1996
Q3A(R2): Impurities in
New Drug Substances (Revised Guideline)
First Recommended for Adoption at Step
4 of the ICH Process on 30 March 1995,
the guideline was revised under Step 2
of the ICH Process on 7 October 1999 and
Recommended for Adoption under Step 4
on 7 February 2002 by the ICH Steering
Committee.
The
guideline addresses the chemistry and safety
aspects of impurities, including
the
listing of impurities in specifications and
defines the thresholds for reporting,
identification and qualification. The
revision of the guideline has allowed clarifying
some inconsistencies, to revise the
decision tree, to harmonize with Q3B and to
address some editorial issues.
The Attachment
2 of this guideline has been revised under
Step4
without
further public consultation on 25
October 2006.
Implementation (Step 5) :
Status : Step 5
October 2006
Q3A(R2)
EU
: Adopted by CPMP,
February 2002,
CPMP/ICH/2737/99
(Revision of CPMP/ICH/142/95)
Revision
of Attachment 2 to be notified
MHLW
: Adopted on 16 December
2002, Notification ELD
n?1216001
Revision of Attachment 2 to be
notified
FDA
:
Published in the Federal Register, Vol, 68, No.
68,
Tuesday February 11, 2003; p.
6924-6925
Revision of
Attachment 2 to be notified
Back to top
Q3B(R2):
Impurities in New Drug Products
(Revised Guideline)
This
guideline has been revised and finalised under
Step 4 in February 2003. It
complements
the guideline on impurities in new drug substances
and provides
advice in regard to
impurities in products containing new, chemically
synthesized
drug substances. The
guideline specifically deals with those impurities
which might
arise as degradation
products of the drug substance or arising from
interactions
between drug substance and
excipients or components of primary packaging
materials. The guideline sets out a
rationale for the reporting, identification and
qualification of such impurities based
on a scientific appraisal of likely and actual
impurities observed, and of the safety
implications, following the principles
elaborated in the parent guideline.
Threshold values for reporting and control of
impurities are proposed, based on the
maximum daily dose of the drug substance
administered in the product.
The Attachment
2 of this guideline has been revised under
Step4
without
further public consultation on 2 June
2006.
Implementation (Step 5) :
Status : Step 5
June 2006
Q3B(R2)
EU
: Adopted by CPMP, March
2003, issued as
CPMP/ICH/2738/99;
Revised Attachment 2 Adopted by
CPMP, June 2006,
CPMP/ICH/2738/99
MHLW
: Adopted on 24 June
2003, PFSB/ELD Notification
n?0624001;
Revised Attachment 2 Adopted 3rd July
2006, PFSB/ELD Notification
N?0703004.
FDA
:
Published in the Federal Register, Vol, 68, No.
220,
Friday November 14, 2003; p.
64628-64629
with the Revised Attachment
2
.
Back to
top
Q3C(R3):
Impurities: Guideline for Residual Solvents
The tripartite harmonised
ICH guideline was finalised (Step 4) in July 1997.
This
recommends the use of less toxic
solvents in the manufacture of drug substances
and dosage forms, and sets
pharmaceutical limits for residual solvents
(organic
volatile impurities) in drug
products.
Impurities: Guideline for Residual
Solvents (Maintenance)
A
Maintenance process has been done to revise PDEs,
as new toxicological data for
solvents
becomes available.
The two
documents have reached Step 4 of the process in
September 2002.
Limit
values for two residual solvents in drug products
were revised on basis of the
newly
recognized toxicity data; lower PDE (permissible
daily exposure) for
N-Methylpyrrolidone
being
kept in Class 2 (limited by health-basis) and for
Tetrahydrofuran
being placed
into Class 2 from Class 3 (no health-based).
Both revisions (PDE for THF and PDE for
NMP) have been incorporated into the core
Guideline in November 2005.
Implementation (Step 5) :
Q3C(R3)
Status :
Step 5
July 1997
EU
: Adopted by CPMP,
September 97, issued as
CPMP/ICH/283/95
MHLW
: Adopted March 1998,
PMSB/ELD Notification
No.307
FDA
: Published in the
Federal Register, Vol. 62, No. 247,
December 24, 1997, page 67377
Q3C Tables and List
[
Word
] or
[
PDF
]
(Posted
11/12/2003); published in FR, Vol.68,
No. 219,
Thursday, November 13, 2003;
pages 64352-64353
PDE for
Tetrahydrofuran
(THF)
Implementation for THF
(Step 5) :
Status :
Step 5
EU
:
Adopted by CPMP, September 2002, issued as
CPMP/ICH/1940/00
MHLW
: Adopted 25 December
2002, Notification ELD
N?1225006
FDA
: The revised PDE is
reflected in the
Q3C Tables
and List
[
Word
] or
[
PDF
]
(Posted
11/12/2003);
published in FR, Vol.68,
No. 219, Thursday,
November 13, 2003;
pages 64352-64353
September
2002
(Incorporated into
the core guideline)
PDE for
N-Methylpyrrolidone
(NMP)
Correction
(Incorporated into
the core guideline)
Implementation for NMP
(Step 5) :
Status :
Step 5
EU
:
Adopted by CPMP, September 2002, issued as
CPMP/ICH/1940/00
MHLW
: Adopted 25 December
2002, Notification ELD
N?1225006
FDA
: The revised PDE is
reflected in the
Q3C Tables
and List
[
Word
] or
[
PDF
]
(Posted
11/12/2003);
published in FR, Vol.68,
No. 219, Thursday,
November 13, 2003;
pages 64352-64353
September
2002
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