USP401226药典的确认中英文对照

2021年1月25日发(作者：奔马图)




1226 VERIFICATION OF COMPENDIAL PROCEDURES
药典方法的
确认





The
intent
of
this
general
information
chapter
is
to
provide
general
information on the verification of compendial procedures that are
being performed for the first time to yield acceptable results
utilizing the personnel, equipment, and reagents available.


此章 节的意图是对药典方法的确认提供基本资料，使用人员，设备和试剂
使第一次进行运用药典方法以产生可 接受的结果。


This
chapter
is
not
intended
for
retroactive
application
to
already
successfully established laboratory procedures. The chapter
Validation
of Compendial Procedures <
1225>
provides general information on
characteristics that should be considered for various test
categories and on the documentation that should accompany
analytical procedures submitted for inclusion in
USP
–
NF.

Verification
consists
of
assessing
selected
analytical
performance
characteristics, such as those that are described in chapter
<
1225>
to generate appropriate, relevant data
rather than repeating the validation process.




此章节并不旨在对已经成功建立的实验室方法进行回顾性运用。章节
〈
12 25
〉药典方法的验证对各种不同检测类别需要考虑的特征以及伴随分
析方法的文件给出了基本 资料。确认包括评估选择的分析性能特征，在
〈
1225
〉叙述，以产生相关的数据而 不是重复验证过程。


Users of compendial analytical procedures are not required to
validate these procedures when first used in their laboratories,
but
documented
evidence
of
suitability should
be
established
under
actual conditions of use. In the United States, this requirement
is established in 21 CFR 211.194(a)(2) of the current Good
Manufacturing Practice regulations, which states that the
“
suitability of all testing methods used shall be verified under
actual conditions of use.
”



不要求药典分析方法的使用者验证实验室第一次使用的方法，但需要具
备在实际使用条件下的适 用性证明文件。
在美国，
此要求确立在
CGMP21
CFR
21 1.194(a)(2)
中，其说明了在实际使用条件下所有使用的的检测方法的
适用性应确认 。


Verification of microbiological procedures is not covered in this
chapter
because
it
is
covered
in
USP
general
chapters
Antimicrobial
Effectiveness <
51>
,
Microbiological Examination of Nonsterile
Products: Microbial Enumeration Tests
61
,
Microbiological
Examination of Nonsterile Products: Tests for Specified


Microorganisms
62
,
Sterility Tests
71
, and
Validation of
Microbial Recovery from Pharmacopeial Articles
1227
.


此章节，不包括微生物方法的确认。因为微生物检测 方法包含在抗菌效果
<51>
、有菌产品的微生物检测：微生物枚举测试
<61>、有菌产品的微生物
检测：特定微生物的检测
<62>
、无菌检查
<71 >
、微生物复苏验证
<1227>


VERIFICATION PROCESS


确认的过程


The verification process for compendial test procedures is the
assessment of whether the procedure can be used for its intended
purpose, under the actual conditions of use for a specified drug
substance and/or drug product matrix.


药典检测方法的确认过程是评估方法是否可用于 其预期的目的
,
在实际条
件下使用指定的药用物质和
/
或药物产品的 矩阵。


Users should have the appropriate experience, knowledge, and
training to understand and be able to perform the compendial
procedures
as
written.
Verification
should
be
conducted
by
the
user
such that the results will provide confidence that the compendial
procedure will perform suitably as intended.



使用者应有适当的经验、知识和培训来了解和能 够演示药典方法。使用
者所做的确认，应是提供了证据：能够证明药典方法能够如预期一样顺利
演示。




If the
verification
of
the
compendial procedure
is
not
successful,
and assistance from USP staff has not resolved the problem, it may
be concluded that the procedure may not be suitable for use with
the
article
being
tested
in
that
laboratory.
It
may
then
be
necessary
to develop and validate an alternate procedure as allowed in the
General Notices
. The alternate procedure may be submitted to USP,
along
with
the
appropriate
data,
to
support
a
proposal
for
inclusion
or replacement of the current compendial procedure.


如果药典方法的确认不成功，以及来自
USP职员的帮助未能解决问题，可
以得出结论方法不适用。有必要开发和验证替代的方法。替代的方法可 以
递交至
USP
，附上适当的数据，以支持包括或取代当前药典方法的建议。


VERIFICATION REQUIREMENTS


确认的要求


Verification requirements should be based on an assessment of the
complexity of both the procedure and the material to which the
procedure is applied.


确认要求应基于方法和方法所分析的物质的复杂性。


Although complete revalidation of a compendial method is not
required to verify the suitability of a procedure under actual
conditions of use, some of the analytical performance
characteristics listed in chapter
1225
,
Table 2,
may be used for
the verification process.