MHRA_OOS_OOT_Oct17 中英 完整版超高清.pdfVIP

Out

of

Specification

Out

of

Trend

Investigations

超标偏离趋势调查

October

2017/2017年10月

How

to

use

the

Investigation

Flowchart/如何使用调查流程图

Navigation

导航:

Clicking

on

those

Process

Step

boxes

with

a

heavy

border

in

a

process

flow

will

take

you

to

a

new

page

with

further

detail

about

that

investigation

step.

点击流程图中深色

框图标，将跳转至详细释调查步骤的新一页幻灯

On

each

page

there

a

link

to

return

to

the

Overview

page

回到主流程页

This

moves

back

upwards

with

a

section

of

the

investigation

step

回到上一调查步骤

This

moves

downwards

to

the

next

page

跳转至下页

2

Overview

Laboratory

Analysis

OOS

(OOT)

Result

Satisfactory

Satisfactory

Phase

la

Investigation

Phase

Ib

Investigation

ManufacturingPhase

II

Investigation

Investigation

Phase

III

Investigation

Product

ImpactBatch

Disposition

Assessment

3

概览

化验室分析

OOS

(OOT)

结果

Satisfactory

满意结果

La阶段调查

Ib阶段调查

生产调查