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小木虫: 金币+0.5, 给个红包，谢谢回帖
zhychen2008: 金币+1, 多谢回帖交流 2013-10-12 17:22:46
R2是版本号吧？
http://www.fda.gov/downloads/reg ... ances/ucm128204.pdf
ATTACHMENT List of Revision 2 Changes
The revisions to this Q1A guidance result from adoption of the ICH guidance Q1F Stability Data
Package for Registration Applications in Climatic Zones III and IV. The following changes
were made.
1. The intermediate storage condition has been changed from 30°C ± 2°C/60% RH ± 5%
RH to 30°C ± 2°C/65% RH ± 5% RH in the following sections:
· II.A.7.a (2.1.7.1) Drug Substance - Storage Conditions - General case
· II.B.7.a (2.2.7.1) Drug Product - Storage Conditions - General case
· II.B.7.c (2.2.7.3) Drug products packaged in semipermeable containers
· Glossary (3) Intermediate testing
2. 30°C ± 2°C/65% RH ± 5% RH has been added as a suitable alternative long-term storage
condition to 25°C ± 2°C/60% RH ± 5% in the following sections:
· II.A.7.a (2.1.7.1) Drug Substance - Storage Conditions - General case
· II.B.7.a (2.2.7.1) Drug Product - Storage Conditions - General case
3. 30°C ± 2°C/35% RH ± 5% RH has been added as a suitable alternative long-term storage
condition to 25°C ± 2°C/40% RH ± 5% and the corresponding example for the ratio of
water-loss rates has been included in the following section:
· II.B.7.c (2.2.7.3) Drug products packaged in semipermeable containers
Midstream switch of the intermediate storage condition from 30°C ± 2°C/60% RH ± 5% RH to
30°C ± 2°C/65% RH ± 5% RH can be appropriate provided that the respective storage conditions
and the date of the switch are clearly documented and stated in the registration application.
It is recommended that registration applications contain data from complete studies at the
intermediate storage condition 30°C ± 2°C/65% RH ± 5% RH, if applicable, by three years after
the date of publication of this revised guideline in the respective ICH tripartite region |
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