美国FDA对GLP常见问题的答复(中文版)

进行的非临床实验研究

?

答

:

不一定。

GLP

的实施计划 对这个问题提供了指导。

FDA

要想拒绝一项研

究

,

必须找到与

GLP

不相依从之处

,

而且

FDA

必须在检查时发现

,

与

GLP

的偏差实

质上损害了研究的质量和完整 性。

的副本必须与研究许可证申请或 上市许可证申请一同呈送吗

?

答

:

不必。

4.

对于在完成以前就被中止的非临床实验研究应该做些什么< /p>

?

答

:

主管 机构承认许多情况

(

疾病暴发、停电等

)

都可能导致非临床实验研究

的过早中止。在这些情况中

,

必须拟定短期的总结报告以说明研究中止的原因。

< br>

5.

对于动物设施的环境控制

(

温度、湿度和照明

),

主管机构是否 制定了允许

限度

?

答

:

没有。这是科学问题

,

必须 在实验方案中予以说明。当然

,

必须保存准

确记录。

来源

:

国家认证中心

美国

< br>FDA

对

GLP

常见问题的答复

(

英文版

)

FREQUENT QUESTIONS AND ANSWERS (FQA)

OF FDA ON GLP

FREQUENT QUESTIONS AND ANSWERS

（

Chinese Version

）

参考

.

学习

.

.

.

.

Since

June

20,

1979,

the

agency

has

been

asked

many

questions

on

the

Good

Laboratory Practice regulations (GLP's, 21 CFR 58). In accord with

agency procedures, responses have been prepared and copies of the

associated correspondence have been filed in the Dockets Management

Branch (HFA-305). The responses have also been provided to the

bioresearch monitoring program managers and to the district offices in

order to ensure consistency of interpretation and equity of program

operation. Unfortunately, the numerous filed correspondences contain

many

repeat

questions

that

are

not

categorized

to

relate

to

the

specific

GLP

suppart

and

section. On

occasion,

the

answers

appear

to

be

somewhat

cryptic. These disadvantages serve to limit the utility of the

correspondences as advisories to our headquarters and field offices.

This

document,

therefore,

consolidates

all

GLP

questions

answered

by

the

agency during the past 2 years, clarifies the questions and answers as

needed, and relates the questions and answers to the specific pertinent

provisions of the GLPs. It represents a digest of some 30 letters, 160

memoranda of telephone conversations, 34 memoranda of meetings and 30

miscellaneous

correspondences

that

have

been

issued

by

agency

personnel.

The

document

does

not

duplicate

questions

and

answers

that

were

dealt

with

in

the

August,

1979

Post

Conference

Report

on

the

Good

Laboratory

Practice

Regulations Management Briefings.

This document should be reviewed by field investigators proir to making

GLP

inspections

and

by

headquarters

personnel

involved

in

the

GLP

program.

Questions should be directed to :

Dr. Paul D. Lepore

Bioresearch Monitoring Staff, HFC-30

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

301-443-1390

SUBPART A

GENERAL PROVISIONS

参考

.

学习

.

.

.

.

Section 58.1 Scope.

1. Do the GLPs apply to validation trials conducted to confirm the

analytical methods used to determine the concentration of test article

in animal tissues and drug dosage forms?

No.

2. Do

the

GLPs

apply

to

the

following

studies

on

animal

health

products:

overdosage studies in the target species, animal safety studies in the

target species, tissue residue accumulation and depletion studies, and

udder irritation studies?

Yes.

3. Do the GLPs apply to safety studies on cosmetic products?

No. Such studies are not carried out in support of a marketing permit.

However,

the

GLPs

represent

good

quality

control;

a

goal

that

all

testing

facilities should strive to attain.

4. Do safety studies done to determine the potential drug abuse

characteristics of a test article have to be done under the GLPs?

Yes they do, but only when the studies are required to be submitted to

the agency as part of an applicaion for a research or marketing permit.

5. Do

the

GLPs

apply

to

the

organoleptic

evaluation

of

processed

foods?

No.

6. Do the GLPs apply