Use of Risk Management
Download
1 / 10

Developing Relationship between - PowerPoint PPT Presentation


  • 379 Views
  • Updated On :

Use of Risk Management in Pharmaceutical Manufacturing Manufacturing Subcommittee Meeting September 17, 2003 Risk Management Process consisting of well-defined steps which, when taken in sequence, support better Decision Making by contributing to a greater insight into

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Developing Relationship between ' - Ava


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Slide1 l.jpg

Use of Risk Management

in Pharmaceutical Manufacturing

Manufacturing Subcommittee Meeting

September 17, 2003


Slide2 l.jpg

Risk Management

Process consisting of well-defined

steps which, when taken in sequence,

support better Decision Making by

contributing to a greater insight into

risks and their impacts


Slide3 l.jpg

More

High

ManufacturingScience

III

Risk

II

I

Less

Low

Regulatory Process Category

III- High; II-Medium; I-Low

Quality By Design Model


Developing relationship between manufacturing science and risk l.jpg
Developing Relationship between Manufacturing Science and Risk

  • Manufacturing Science α Risk

  • Solve for α?

  • How can it be solved consistently and systematically using validated models?


Manufacturing science l.jpg
Manufacturing Science

  • Primary Attributes

  • Process Knowledge

  • Process Capability

  • Manufacturing Technology

  • Process Control Technology

  • Quality Systems Infrastructure


Manufacturing science6 l.jpg
Manufacturing Science

  • Primary Attributes

  • Process Knowledge

  • Process Capability

  • Manufacturing Technology

  • Process Control Technology

  • Quality Systems Infrastructure

  • FMEA uses a systematic way of examining all ways in which a failure can occur within a process, and then identifies all the potential root causes of each failure. For each failure an estimate is made on the effect of the whole system, in our case, Quality. This would include how often the failure could occur, the severity of the failure, and the ability to detect. This is the start of defining the critical quality attributes and parameters.


  • Manufacturing science7 l.jpg
    Manufacturing Science

    • Primary Attributes

    • Process Knowledge

    • Process Capability

    • Manufacturing Technology

    • Process Control Technology

    • Quality Systems Infrastructure

  • Using FMEA to define the critical quality attributes and parameters, define the process capability to meet the acceptable ranges. If process capability is well within acceptable range, then additional risk mitigation is not necessary. If process capability cannot ensure process reliability within acceptable ranges, then risk mitigation strategies should be explored.


  • Manufacturing science8 l.jpg
    Manufacturing Science

    • Primary Attributes

    • Process Knowledge

    • Process Capability

    • Manufacturing Technology

    • Process Control Technology

    • Quality Systems Infrastructure

  • A risk mitigation strategy considered when critical quality attributes and parameters cannot reliably be ensured in the process to meet acceptable ranges.


  • Manufacturing science9 l.jpg
    Manufacturing Science

    • Primary Attributes

    • Process Knowledge

    • Process Capability

    • Manufacturing Technology

    • Process Control Technology

    • Quality Systems Infrastructure

  • A risk determination can be made by the FDA based on the outcome of comprehensive Quality System inspectional outcomes for specific sites.


  • Developing relationship between manufacturing science and risk10 l.jpg
    Developing Relationship between Manufacturing Science and Risk

    • Primary Attributes

    • Process Knowledge

    • Process Capability

    • Manufacturing Technology

    • Process Control Technology

    • Quality Systems Infrastructure

  • Risk will equal the aggregate evaluation of the elements above as determined by the manufacturer.


  • ad