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.

0
shares

  • 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.

Similar articles:

An Alternative View of the ICH Q10 Pharmaceutical Quality System (PQS)

The image below is that depicted by the International Conference of Harmonisation (ICH) Q10, Annex 2, and is supposed to depict a PQS or Pharmaceutical Quality System.

Typically, I really love the ICH. When we have to deal with outdated regulations from different global organizations it becomes a real nightmare trying to keep track of the nuances and the ICH has done a pretty good job of bringing several of the key organizations together and aligning them on how best to organize and meet the expected requirements.

That being said the diagram below and the depiction in Q10 of what a PQS should look like is greatly lacking.

Development Phases

In section 1.8 under the Quality Manual the ICH Q10 guidance states, “The description of the PQS should include: …(c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and interdependencies.

Process maps and flow charts can be useful tools to facilitate depicting the pharmaceutical quality system processes in a visual manner”.

I completely agree.

The problem is using the graphical depiction they present in Annex 2 is completely worthless.

Basically they listed some of the PQS elements in a bar and then said they all apply to the entire product lifecycle, which simply isn’t true.

When we are in the development phase of our product lifecycle why would we do that under the change management system, or monitor process performance?

 

Controlling Change – No Value Add

There is no point in controlling changes for a product that is purposely being changed, nor does it offer any value to monitor the process performance for a process that has yet to be developed.

This isn’t a graphic depiction of the PQS, but rather a graphic of how they depict the lifecycle management (which also has some issues).

The PQS is the quality system and its subsystems and how they interrelate.

While it’s useful to look at how the PQS and product Lifecycle Management overlap and what elements of the PQS system are relevant at each lifecycle stage, it is not the point of the PQS, and even if that’s the end goal it’s not depicted here at all.

This image offers almost no value.

A Better Approach

So, what should this graphic look like?

While this is not a perfect view of a PQS, I would propose that the image below is a much better depiction of how the PQS should be visualized and a good place to start.

At the core of any quality system should be management. This goes back to Deming, who said, “Quality begins with the intent that is fixed by Management”.

Quality has to be rooted in the executive management team.

Define Core Quality Systems

Core quality systems then need to be defined. These are systems that impact all aspects of the business and include a Risk Management Policy, Resource Management, Document Control and CAPA systems.

All of the other subsystems, Deviations, Supplier Management, Equipment Qualifications, Validation, Material Management, etc, etc. all should be risk based or involve risk assessment, they all require resources and training, they call require documents (procedures, policies, records), and the CAPA system of course drives for process improvement regardless of the process.

Subsystems

All subsystems feed back into the main Management module. The subsystems listed, all are interconnected, with the exception of Post Market Systems.

The subsystems are important too, but they are farmed out to different groups and have different levels of importance depending on the stage of the product lifecycle.

Post Market Systems

The one exception is the Post Market Systems. This includes complaint management, product reviews, recall processes and other systems to support marketed products.

These generally do not interact with the other subsystems unless it is through the CAPA system or other management functions, but still utilizes all the systems under the management umbrella.

Alternate View

The PQS presented here, isn’t intended to be perfect, but I thought it was worth presenting an alternate view to the one presented by the ICH.

The ICH concept is a good one, and the ideas are fairly well laid out in the ICH, but the graphical representation of the PQS leaves a lot to be desired.

When establishing a PQS, it is better to start with something to what we’ve depicted here, and customize it as needed for the organization.

6
shares

Similar articles:

How 21 CFR Part 11.3(7) Applies to Electronic Batch Records [Video]

When dealing with Part 11 it’s important to understand what an electronic signature actually means

The definition of electronic signatures or e-sigs can be found in 21 CFR Part 11.3(7).

Electronic Signature

An electronic signature or e-sig means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Handwritten Signatures

We also need to understand what a handwritten signature means in the context of Part 11.
The definition of handwritten signatures can be found in 21 CFR Part 11.3(8).

Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.

The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

Electronic Batch Records

Eric works in a Pharmaceutical company and he is responsible for the filling process of the batch been manufactured.

Each time Eric performs the filling process he has to populate a batch record with the appropriate details

After each step Eric must also fill in his signature and date to verify that he actually performed each task.

Eric is manually handwriting these details and they are legally binding to Eric.

21 CFR Part 11.3(8)

This is when 21 CFR Part 11.3(8) applies.

Fast forward 12 months and Eric’s company has implemented a brand new Manufacturing Execution System (MES) where all details around the batch manufacturing process are recorded electronically.

21 CFR Part 11.3(7)

Now when Eric performs the filling process he now populates everything electronically and signs with his username and password combination to verify that he has performed those tasks.

This is when 21 CFR Part 11.3 (7) applies.

0
shares

TOP

Similar articles: