Equipment Validation – Where Do I Start?

So your boss asks you to formulate a template to validate all of the equipment types in your organisation, where do you start? Seems like a very daunting task, how can you formulate a template that will include all the essential elements of equipment validation.

Let’s say for example you are working in the Medical Device field what regulations should you base the requirements on?

The Requirements

The main requirements that should be focussed on include:

  • (FDA) Design Control Guidance for Medical Device Manufacturers (March 11, 1997)
  • GHTF/SG3/N99-10:2004 (Edition 2) Process Validation Guidance for Medical Device Manufacturers endorsed by ICH, January, 2004
  • FDA Compliance Guidance-General Principles of Process Validation. US Food and Drug Administration Center for Drugs and Biologics and Devices and Radiological Health, May 1987

So lets break down what needs to be qualified in order to bring the equipment into a state of compliance. Remember this is just a starting point, for a full list please refer to the requirements above.

1. Documentation

a) All relevant equipment drawings are available and verified:

  • Mechanical drawings
  • Electrical schematics
  • Process & Instrument drawings
  • Pressure/Vacuum Rating ASME Code Stamp)

b) User manual

c) Spare part list

d) Software Documentation (ex. Ladder Logic) E-copy and hard copy (if applicable)

2. Equipment Design/Component Verification

a) All major Equipment/Components design verified via Design Qualification or equivalent (ex. Approved Engineering Specifications and Design Review and/or IQ verification).

b) Certification of materials of construction used, equipment finish.

c) Main components within preventive maintenance program.

d) Special cleaning and intervals established, if applicable.

3. Verification of Critical Instrument Calibration

a) Primary Instruments listed in the calibration program (i.e. control and process monitoring instruments, not backup indicators).

b) Instrument Resolution and Accuracy are identified and adequate for process control range required.

c) Traceable Standards Used.

4. Utilities Supply

a) Electricity (With all connections verified)

b) Clean steam boiler (With all connections verified)

c) Compressed air (With all connections verified)

d) Nitrogen (With all connections verified)

5. Environmental requirements

a) Temperature

b) Humidity

c) Lighting

d) Noise level

e) Electrostatic discharge isolation

6. Safety Code

a) Electrical wiring/disconnects

b) OSHA or AFS applicable standards for noise level

7. SOPs Availability

a) Operation

b) Software (PLC) Configuration Control and Disaster Recovery

c) PM

d) Cleaning

8. Validation Instrumentation

a) Validation instruments used in IQ are listed and within calibration due date.

Summary

This is not an exhaustive list but it will help anyone new to equipment validation to get a taste of what is involved when you are
developing your IQ, OQ, PQ, FAT or SAT documentation.

If you would like to learn more about equipment validation click here to post your queries.

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  • DURGA PRASAD

    Very well written.
    As the latest validation guidance is having terms like verification and testing its good to add ISO documents also in the requirements list.
    The whole article gave a clear path where and how to start.
    I thank the moderator for sharing such a good article.
    Regards

  • DURGA PRASAD

    Very well written.
    As the latest validation guidance is having terms like verification and testing its good to add ISO documents also in the requirements list.
    The whole article gave a clear path where and how to start.
    I thank the moderator for sharing such a good article.
    Regards

  • Shahid Ali

    Thanks, You have comprehensively listed out every single bit required to be covered in IQ/OQ protocol, I hope this will be a great help for those who are planning to start Equipment Qualification.

  • Shahid Ali

    Thanks, You have comprehensively listed out every single bit required to be covered in IQ/OQ protocol, I hope this will be a great help for those who are planning to start Equipment Qualification.

  • bld

    This is a great list for the IQ of the equipment. Do you have any recommendations of how to determine the OQ requirements for the equipment. What documents would you refer to for determining critical functionality that should be tested before release. Manufcturing technical specifications are a great start but are sometimes hard to get. Also how would you determine whether the OQ covers all items that would be required before releasing for manufacturing use? or whether a PQ is also required. Some items such as environmental controlled areas need PQ above operational qualification

  • bld

    This is a great list for the IQ of the equipment. Do you have any recommendations of how to determine the OQ requirements for the equipment. What documents would you refer to for determining critical functionality that should be tested before release. Manufcturing technical specifications are a great start but are sometimes hard to get. Also how would you determine whether the OQ covers all items that would be required before releasing for manufacturing use? or whether a PQ is also required. Some items such as environmental controlled areas need PQ above operational qualification

  • abu rafey khan

    Dear Sir your are really having a very nice knowledge on need based qualification.

    With regards
    abu rafey khan

  • abu rafey khan

    Dear Sir your are really having a very nice knowledge on need based qualification.

    With regards
    abu rafey khan

  • anvardeen2010

    HI ,

    I want some information on old equipment qualifications. we have purchased some equipments on 2005 , but we didn’t perform qualifications on those equipments. Now we are planning for commercial production. As per the regulatory needs we should completed the qualifications for all critical equipments.

    My question is how to do qualifications for old equipments. Whether we have to do it as retrospective method or some procedure. please guide me how to do first time qualifications for old equipments. Please suggest the me the reference guideline for this situation.

  • anvardeen2010

    HI ,

    I want some information on old equipment qualifications. we have purchased some equipments on 2005 , but we didn’t perform qualifications on those equipments. Now we are planning for commercial production. As per the regulatory needs we should completed the qualifications for all critical equipments.

    My question is how to do qualifications for old equipments. Whether we have to do it as retrospective method or some procedure. please guide me how to do first time qualifications for old equipments. Please suggest the me the reference guideline for this situation.

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