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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‘To the Cloud or not to the Cloud, that is the question.’

While it’s certainly a familiar question, with apologies to Hamlet, there is a question that tends to come first: “What is the Cloud in the first place?” Have you seen this on-line graphic lately of a young child who is just looking at you with the caption – ‘There is no cloud…’

Information Workers

The reality for most ‘information workers’ is that as long as your keyboard, mouse and monitor have something to plug into and data displays, all you really need to see is where that ‘something’ plugs into the wall so you can be sure you have a physical connection.

What’s on the other side of the wall – or even if there is strictly speaking no ‘other side’ – is not the users concern. You don’t need to have physical computing resources right next to you as long as the ‘virtual machine’ you are working on is properly provisioned and the latency (or ‘lag/response time’) isn’t large enough to be an issue.

Enterprise

The physical computing resources matter if you are doing a lab analysis with physical samples on instruments or using an automated line to produce product. In the land of data analysis, reporting and document production, the data needs to be available, not present.

From the enterprise perspective however, what is ‘present’ behind the wall is a true concern. Since compliance to regulations means ‘control,’ how the cloud supplies and protects those resources and the information they provide needs to be documented under a defined quality management system. While cloud vendors are glad to quote services and prices, they have not always been forthcoming about how things are done in their building.

Outsourcing

The move to the cloud is a physical move – of your data, applications and possibly compute and platforms – to somewhere else. The somewhere is physical while your usage and controls become logical and virtual. If that makes you feel uneasy – or if you prefer ‘risk averse’ – you are not alone.

Outsourcing is a concept that brings joy to financial / accounting types, but for those involved with compliance, quality and validation, it brings a new set of challenges and concerns. It should recall the words of Mr. Murphy – “Nothing is as easy as it looks, everything takes longer than you expect AND if anything can go wrong, it will – usually at the worst possible time.”

Current warning letters addressing data integrity have focused on site forensics – data in trash cans, bags of shredded records. When it comes to the cloud, there is no ‘there’ for you to access – unless there are the careful negotiations, detailed SLAs and rigorous audit/ follow-up required to give your enterprise the confidence it needs to move forward.

Do your current internal resources have the expertise and the flexibility to deal with a vendor you have to trust significantly? This is more complex than a contract manufacturer where you can review the SOPs for compliance, watch the process and then have the product independently tested.

GxP Compliance

The draw of the cloud is that everything is ‘out there’ – available ‘just by an e-mail’ – and not running up costs on your premises. What will happen if suddenly it isn’t ‘there?’ Whose fault will it be – oh, must be the vendor. Good idea – blame the vendor – but there’s many a wire between your ‘here ‘ and their ‘there.’

Will it be your communication vendor, some nameless third party supplier or cloud hardware, software or internal network failure? There are many ABCs in the cloud – SaaS, IaaS, PaaS, Haas, AaaS, ITaaS – and the list goes on. It is critical to have the proper support to be able to straighten all those letters out to spell ‘GxP compliance.’

Cloud Provider

Everyone wants their cloud provider to look like the image below. But that will take attention to detail, technical understanding and the ability to ask ‘the next questions’ needed to assure quality and compliance.

Those will include security at multiple levels and how are they going to maintain those perfect cables when the one in the middle breaks?

There are many items to be considered – here are some more:

  • What application(s) and data are going to be ‘sent to the cloud?’
  • What in-house processes / systems need to access that data?
  • Where will the data physically be held and what are the laws in that location if outside of the USA?
  • What are the backup provisions for the cloud providers’ servers and storage?
  • What is the security plan – including physical, logical and access controls?
  • How will your audit resources be granted access and under what ground rules?
  • Does the vendor provide a Quality Manual or Quality Management System document for review?
  • Does their contract include a ‘non-cookie cutter’ Service Level Agreement (SLA) that details your focus points?

John English is an independent contractor with The Azzur Group.

If you would like any help with CSV related projects please visit www.azzur.com.

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Changes to equipment and documentation is an integral part of the whole GMP process in any regulated facility. In this article we will discuss how equipment is designed in a GMP facility and how good documentation practices are an essential part of quality assurance and GMP.

The content of this article has been taken from module 7 of our eLearning module on Good Manufacturing Practices (cGMP) within the life sciences.

You can view this module in full by viewing the video below.

cGMP eLearning Module – Compelling, Engaging and Interactive

 

Equipment

All equipment is designed, constructed and located to suit their intended use and to facilitate easy maintenance and cleaning.

Equipment is installed in such a way as to prevent any risk of error or of contamination, and cleaned according to detailed and written procedures and stored only in a clean and dry condition.

Production equipment should be designed in such a way as not to present any hazard to the products.

The parts of the production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard.

Any defective equipment should, if possible, be removed from production and quality control areas, or at least be clearly labelled as defective. When not in use, equipment should be covered to ensure it remains clean.

Balances

Balances and measuring equipment of an appropriate range and precision should be available for production and quality control operations.

All measuring devices are required to be calibrated and checked at defined intervals by appropriate methods, and adequate records of such tests should be maintained.

Utilities

Fixed piping should be clearly labelled to indicate the contents and where applicable, the direction of flow.

Water pipes used in production (e.g. Purified Water, Water for Injection) are sanitised according to written procedures that detail the action limits for microbiological contamination and the measures to be taken.

Electrical circuits should be identified, and a record maintained of the load on each circuit to prevent inadvertent overload.

Documentation

Good Documentation Practices are an essential part of quality assurance and GMP.

It is important for a manufacturer to get the documentation right in order to get the product right.

GMP Documentation e.g. Site Master File, Specifications, Batch Manufacturing Formulae, Batch Manufacturing Records, Processing, Labelling, Packaging, Testing Instructions, Standard Operating Procedures, Protocols, Technical Agreements, Records, Certificates of Analysis, Reports etc. should contain the following attributes of a good document:

They should be:

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete
  • Durable
  • Corroborated
  • Version Based
  • Accessible
  • And Authorized

Change Control

Change to GMP documentation, equipment, processes, systems, instrumentation, test methods, etc. are required to be controlled under a formal change control program.

This program must consist of Quality oversight to review the proposed changes, evaluate the potential impact of the change, determine any potential risk to product quality, and to establish the required level of supplemental validation/documentation required for the change.

In many instances, changes will also require submission to the Health Authority for approval of the change.

For example, changes impacting the submission documentation are subject to post approval change guidances according to the Health Authority regulations.

Change Control is a critical aspect of the GMP systems.

If you want to learn more about cGMP or if you want to evaluate our eLearning module for your company you can find more information here.

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