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如何通过风险评估制定验证周期
浏览次数:1651次 更新时间:2017-04-19

如何通过风险评估制定验证周期


RR&F for Periodic Validation Frequency

使用风险分级和过滤工具评估验证周期


Background:

背景


You work in a quality group for an end user company within the biopharmaceutical, medical device or contract research industry. Your company has asked you to establish the validation frequency. Since you would like to focus your efforts and the efforts of your company on the more risky systems, with respect to patient safety andproduct quality, you decide to apply a risk management philosophy toward the setting of periodic validation frequencies.

你工作在一个生物制药、医疗器械或者外包的研究企业的质量部门,你的公司希望你制定验证的周期。因此你希望将精力集中在对患者安全和产品质量有较高风险的系统上,你需要为验证周期的制定提供一个风险管理的方法.


Tasks at Hand:

做法


1. Determine the list of potential periodic validation frequencies that may be applied.

列出可能会使用的周期性验证的频率列表


  • 1 Year

  • 一年

  • 2 Years

  • 2年

  • Years (EMA feels that 4 years is the maximum allowable for a given system)

  • 数年(EMA认为最多4年)


2. Select a risk assessment tool for prioritizing periodic validation frequencies for GxP systems at your site.

选择一个对GxP系统周期性验证频率的风险评估工具


  • Qualitative

  • 定性的

  • HAZOP

  • 危险与可操作性

  • HACCP

  • 危害与关键控制点

  • PHA

  • 初步危险分析

  • FMEA

  • 失效模式与影响分析

  • RR&F

  • 风险分级和过滤


Since this exercise is asking for prioritization, thistakes us immediately to PHA, FMEA or RR&F tools. It seems to make sense toput the vendors into relative “buckets”.

由于它需要一个优先评级,因此我们立马想到PHA、FMEA或者RR&F工具。


Also, since we are not asking for an in-depth anddetailed technical analysis, that would drop the FMEA out of the running, whichbrings us down to a PHA or RR&F. When applying risk management and/or risk assessmenttools, always remember to consider which decision you are trying to make. Inthis case, the decision we are looking to make is which vendors should beaudited via questionnaire, over the telephone, in person or not all based on acertain set of criteria; and we are not asking to assess the controls we havein place or should put into place in order to mitigate risk.

由于我们不需要一个深入和详细的技术分析,因此可以将FMEA排除在外,可以选择PHA或者RR&F。使用风险管理和/或风险评估工具的时候,同时也要考虑需要采取何种措施。在这种情况下,我们决定供应商是否需要进行调查表、电话或者现场审计取决于一个明确的标准;以及我们不需要评估所采取的降低风险的控制措施。


Therefore, I believe the R&F tool may be the mostappropriate risk assessment tool for this exercise.

因此,RR&F工具应该是对此最适合的风险评估工具。


3. Determine the criteria you would like to usein assessing the periodic validation frequency for GxP systems.

决定在对GxP系统评估周期性验证频率时使用的标准


  • Possibility that the equipment beyond the valid status after being  qualified(P).

    系统失效的可能性(P


             Size of System (# of  Users)

             系统大小(使用者的数量)

             # of Changes to the System  per year

             每年发生变更的数量

             # of Deviations to the System  per year

             每年发生偏差的数量

             Complicacy of System(e.g. COTS, Configuration  or Bespoke Software for computerized system)

             系统复杂程度(例如,对于计算机化系统,是商用现货、可配置的组态还是定制化软件)

             History data of the system

             系统的历史数据

             


  • Severity that the system beyond the valid status after being  qualifiedS

  • 系统失效的严重性(S

             Product quality

             产品质量

             Complaint

             投诉

             Therapeutical effect

             药效

             Medication safety

             用药安全

             


4. Develop RR&F Tool Below:

完成风险评级和过滤表格


Criteria

标准

Low = 1

低(1分)

Medium = 2

中(2分)

High = 3

高(3分)

Possibility that the equipment beyond the valid status after being  qualified(P).

系统失效的可能性(P

             Size of System (# of  Users)

             系统大小(使用者的数量)

             # of Changes to the System  per year

             每年发生变更的数量

             # of Deviations to the System  per year

             每年发生偏差的数量

             Complicacy of System(e.g. COTS, Configuration  or Bespoke Software for computerized system)

             系统复杂程度(例如,对于计算机化系统,是商用现货、可配置的组态还是定制化软件)

             History data of the system

             系统的历史数据

             

Severity that the system beyond the valid status after being  qualifiedS

系统失效的严重性(S

             Product quality

             产品质量

             Complaint

             投诉

             Therapeutical effect

             药效

             Medication safety

             用药安全

             


Green

绿色
  (LOW = L)

Yellow

黄色
  (MEDIUM = M)

Red

红色
  (HIGH = H)

< 2

3 to 5

 

6 to 9


System

系统

Score

得分

Color

颜色

Frequency

频度

XX Production Equipment

XX生产设备

2 x 3 = 6

Red

1 Years

1

LIMS System for Issuing  Certificates of  Analysis

发布分析报告的LIMS系统

1 x 3 = 3

Yellow

2 Years

2

Document Management System

文件管理系统

1 x 3 = 3

Yellow

2 Years

2

Environmental Monitoring  System

环境监测系统

1 x 3 = 3

Yellow

2 Years

2

注:对于法规明确要求周期的,可能不适用本方法。



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