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    ISO/GMP/FDA Training Validation: Topic: Date: 2/23/2012 Facility: SS White India Trainer: Hollie Johnson

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    Mitul
    The document summarizes key points about validation from a training presentation: [1] Validation is the documented process of demonstrating that equipment, processes, and procedures will consistently produce the expected results according to predetermined specifications. It includes qualifying systems and equipment. [2] Validation involves installation qualification, operational qualification, and performance qualification to test equipment and processes. It is required by regulations to ensure consistent, high-quality products. [3] Examples of items that can and will be validated at the facility include CNC equipment, test equipment, cleaning processes, and passivation systems.

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    ISO/GMP/FDA Training Validation: Topic: Date: 2/23/2012 Facility: SS White India Trainer: Hollie Johnson

    Uploaded by

    Mitul
    202 views17 pages
    The document summarizes key points about validation from a training presentation: [1] Validation is the documented process of demonstrating that equipment, processes, and procedures will consistently produce the expected results according to predetermined specifications. It includes qualifying systems and equipment. [2] Validation involves installation qualification, operational qualification, and performance qualification to test equipment and processes. It is required by regulations to ensure consistent, high-quality products. [3] Examples of items that can and will be validated at the facility include CNC equipment, test equipment, cleaning processes, and passivation systems.

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    Validation

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    Validation

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    The document summarizes key points about validation from a training presentation: [1] Validation is the documented process of demonstrating that equipment, processes, and procedures will consistently produce the expected results according to predetermined specifications. It includes qualifying systems and equipment. [2] Validation involves installation qualification, operational qualification, and performance qualification to test equipment and processes. It is required by regulations to ensure consistent, high-quality products. [3] Examples of items that can and will be validated at the facility include CNC equipment, test equipment, cleaning processes, and passivation systems.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    202 views17 pages

    ISO/GMP/FDA Training Validation: Topic: Date: 2/23/2012 Facility: SS White India Trainer: Hollie Johnson

    Uploaded by

    Mitul
    The document summarizes key points about validation from a training presentation: [1] Validation is the documented process of demonstrating that equipment, processes, and procedures will consistently produce the expected results according to predetermined specifications. It includes qualifying systems and equipment. [2] Validation involves installation qualification, operational qualification, and performance qualification to test equipment and processes. It is required by regulations to ensure consistent, high-quality products. [3] Examples of items that can and will be validated at the facility include CNC equipment, test equipment, cleaning processes, and passivation systems.

    Copyright:

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    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
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    ISO/GMP/FDA Training Topic: Date: Facility: Trainer: Validation 2/23/2012 SS White India Hollie Johnson

    Validation

    documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practices and other regulatory requirements. Validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification

    The activity of qualifying systems and equipment is divided into the following: qualification (DQ) Component qualification (CQ) Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ)
    Design

    WHY DO WE VALIDATE?

    FDA(21 CFR 820.75) and ISO 13485 require it High probability that product will pass specs Reduces in-process/finished goods testing Reduces scrap/rework, saving money Consistent products have fewer complaints Validation generates ideas for improvement Build quality in, not try to inspect it in

    History

    Introduced by FDA in mid 1970s to improve the quality of pharmaceuticals Started as a focus on improving manufacturing processes Quickly spread to other areas (next slide) All regulations are a direct result of some catastrophic event that occurred in real life Validation is no exception Therac-25 incident

    What CAN We Validate?

    Systems Passivation, compressed air New Processes, prospective cannot inspect 100% Existing processes Retrospective Test Equipment Comparators Equipment CNC Software CNC Programs, Databases Security Electronic Signature People Repeatability and ability to follow procedures Product CNC, winding, assembly Facility Design, construction, materials, layout Utilities Air, water, HVAC

    Cleaning ultrasonic, hand cleaning Analytical Methods - titration Packaging, shipping Sterilization Design Manufacturing SOPs and Methods Technology Transfer Suppliers Automated Systems passivation, CNC Anything that affects product quality Endless

    What WILL We Validate?


    Equipment

    CNC IOQ Test Equipment Comparators Systems Passivation, compressed air Cleaning ultrasonic, hand cleaning

    WHEN DO WE VALIDATE
    When

    product testing isnt sensitive enough to verify product safety & effectiveness. When testing would destroy the product to prove the result. Destructive testing (UTS). When we cannot inspect 100%

    HOW DO WE VALIDATE?

    Start with a Plan Validation Master Plan (VMP)(process, equipment and cleaning VMP) Write protocol Specified equipment, methods, SOPs, Training, calibration 3 successive runs (process qualification) Statistically valid sampling plan Measurable, predetermined acceptance criteria (specifications)

    INSTALLATION /OPERATION QUALIFICATION (IQ/OQ)


    Verifies

    correct equipment installation Assures that measuring and monitoring equipment is calibrated, and personnel are trained verifies that equipment operates correctly at process settings. Process settings include worst case (high and low) conditions and most common.

    PROCESS PERFORMANCE QUALIFICATION (PQ)


    This

    is what we usually call Process validation. Demonstrates the process is reproducible and effective at normal and extreme operating limits. Includes worst case (low), worst case (high) and average case.

    WHAT TRIGGERS REVALIDATION


    Preventive

    Maintenance Change in raw material and/or supplier Change in process or equipment According to schedule ECO form or change control has a place to identify need for validation Unanticipated event/incident. Move equipment

    DESIGN OF EXPERIMENTS (DOE)


    Using

    this technique, a few experiments tell us quickly what parameters control the process. We can find and test the limits easily. Used to develop acceptance criteria Statistically valid means of designing your qualification protocols

    SS White India Validation Requirements

    Required to do equipment Validation

    IOQ Protocol template will be provided to you You are required to update protocol and submit to NJ for approval execute the protocol Manage training, documentation and calibration Write an executive summary report of the data and include al relevant attachments Manage deviations and justifications Submit report to NJ for final approval

    SN Validation Requirements Cont


    Promptly report all deviations and discrepancies to Hollie Need to hire local talent if resources spread too thin All data pages are reviewed and signed/dated by Quality manager in SN All Validation documents are controlled documents with an individual FCD number All data requires a second person to look at the data and verify accuracy in addition to the final review of the entire data page Scan the final approved protocol, report and attachments

    QUESTIONS???

    THE END

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