Instrument Qualification (IQ) Protocols

[Milas]

Hi

I am reaching out to acquire comments and feedback for Instrument Qualification (IQ) Protocols, associated with the Medical device industry.

21 CFR 820, ISO13485 and GMP state that Validation (which IQ, OQ and PQ fall under) needs to be carried out on an instrument or process in the event the output cannot be verified by the subsequent process...or words to that effect. As we would like to have a consistent approach and for business reasons, we have decided to go down the route of performing IQ's, irrespective of whether the output can be verified by the subsequent process.

My understanding of performing IQs is, establishing that the instrument is received as designed and that it' correctly installed in the selected environment. In other words, check the instrument is not damaged during delivery, it powers on, has been installed in the correct environment and has the correct utilities. To me this should be 2-3 page checklist/protocol which then needs to be signed off by the relevant approvers. However, we do have colleagues who feel this approach is to lite and insist on a more thorough and detail IQ protocols, which is some 20 -pages long and takes hours upon end for Engineers to write the protocols and subsequently execute.

Does anyone have any thoughts or experience on this and what is the best approach, or better still share an IQ protocol .

Adam

 

[imecoli]

What details are they asking for that makes it a 20 page document? is this large specialty equipment?

 

[Milas]

What details are they asking for that makes it a 20 page document? is this large specialty equipment?

Some examples include the following:

For ovens, they are requesting that temperature mapping should be carried out, loaded or unloaded, temperature mapping should sit under OQ ? for ancillary devices, they insist that each ancillary device is treated as its own IQ.

 

[kuyakut]

For IQ, basically you have to check the installation requirements if it is according to the equipment manufacturer installation guidelines. For Oven you need to go through IQ then OQ and PQ, you need to establish a temperature range that gives you acceptable results on the product that you are going to put in the oven. A 4 to 5 pages should be enough for you carried out IQ protocol and Report. Temperature mapping should be in IQ.

 

[Parul Chansoria]

@Milas the level of detail in Installation Qualification (IQ) for an equipment depends on several factors, and the decision to opt for a comprehensive or a simpler IQ is based on risk assessment, regulatory requirements, and the criticality of the equipment to the processes involved. Whenever, I decide if I should go for a long 20 page something IQ or a short 2 to 4 pages IQ, I would take into account the following considerations:

1. Risk Assessment:
   • Evaluate the risk associated with the equipment's installation on the overall manufacturing or testing processes. High-risk equipment or those critical to product quality can warrant a more detailed IQ.
2. Equipment Criticality:
   • Consider the criticality of the equipment to product quality and safety. If the equipment plays a crucial role in compliance with regulatory standards or if its failure could impact product integrity, a more comprehensive IQ is advisable.
3. Regulatory Requirements:
   • Refer to applicable regulatory standards such as ISO 13485 for medical devices or the IVD Directive/Regulation. Some regulatory bodies may provide specific guidelines on the level of detail required for IQ documentation.
4. Manufacturer Recommendations:
   • Follow the equipment manufacturer's recommendations and guidelines. Some manufacturers provide detailed IQ protocols tailored to their equipment, and adherence to these guidelines may ensure proper installation and performance.
5. Complexity of Equipment:
   • The complexity of the equipment may influence the level of detail required in the IQ. Complex systems or equipment with multiple components may demand a more extensive IQ process.
6. Previous Experience:
   • Consider the organization's historical experience with similar equipment. If there is a track record of trouble-free installations and if the equipment is well-understood, a simpler IQ may suffice.
7. Process Impact:
   • Assess how the equipment's performance directly impacts critical processes. If the equipment failure could disrupt operations, compromise product quality, or pose safety risks, a thorough IQ is recommended.
8. Resource Allocation:
   • Balance the need for a detailed IQ with available resources. A cost-benefit analysis should be considered to avoid unnecessary documentation for lower-risk equipment.

Finally, there is no right or wrong approach when it comes to IQ, OQ, PQ, however, whichever approach you decide to proceed with should be backed with reasonable justification, thought of ultimately in the best interest of patients and users.

Best,
Parul Chansoria

 

[Milas]

@Milas the level of detail in Installation Qualification (IQ) for an equipment depends on several factors, and the decision to opt for a comprehensive or a simpler IQ is based on risk assessment, regulatory requirements, and the criticality of the equipment to the processes involved. Whenever, I decide if I should go for a long 20 page something IQ or a short 2 to 4 pages IQ, I would take into account the following considerations:

1. Risk Assessment:
   • Evaluate the risk associated with the equipment's installation on the overall manufacturing or testing processes. High-risk equipment or those critical to product quality can warrant a more detailed IQ.
2. Equipment Criticality:
   • Consider the criticality of the equipment to product quality and safety. If the equipment plays a crucial role in compliance with regulatory standards or if its failure could impact product integrity, a more comprehensive IQ is advisable.
3. Regulatory Requirements:
   • Refer to applicable regulatory standards such as ISO 13485 for medical devices or the IVD Directive/Regulation. Some regulatory bodies may provide specific guidelines on the level of detail required for IQ documentation.
4. Manufacturer Recommendations:
   • Follow the equipment manufacturer's recommendations and guidelines. Some manufacturers provide detailed IQ protocols tailored to their equipment, and adherence to these guidelines may ensure proper installation and performance.
5. Complexity of Equipment:
   • The complexity of the equipment may influence the level of detail required in the IQ. Complex systems or equipment with multiple components may demand a more extensive IQ process.
6. Previous Experience:
   • Consider the organization's historical experience with similar equipment. If there is a track record of trouble-free installations and if the equipment is well-understood, a simpler IQ may suffice.
7. Process Impact:
   • Assess how the equipment's performance directly impacts critical processes. If the equipment failure could disrupt operations, compromise product quality, or pose safety risks, a thorough IQ is recommended.
8. Resource Allocation:
   • Balance the need for a detailed IQ with available resources. A cost-benefit analysis should be considered to avoid unnecessary documentation for lower-risk equipment.

Finally, there is no right or wrong approach when it comes to IQ, OQ, PQ, however, whichever approach you decide to proceed with should be backed with reasonable justification, thought of ultimately in the best interest of patients and users.

Best,
Parul Chansoria

Parul

Thank you for the comprehensive feedback. But i still need to ask that, although the output can be verified at the subsequent process, an IQ is still required with the above taken into account?

 

[Parul Chansoria]

Parul

Thank you for the comprehensive feedback. But i still need to ask that, although the output can be verified at the subsequent process, an IQ is still required with the above taken into account?

@Milas yes an IQ would be required, as it is a crucial step in the validation process for equipment used in the medical device industry. Skipping the IQ step is not advisable and this could pose risks to the functionality, performance, and safety of the equipment. We can only play with the level of details in the qualification process based on the considerations mentioned above. Your equipment supplier may provide an Installation Qualification protocol that can you can customize to your specific installation environment.

 

[Tidge]

I prefer that IQs (in medical device manufacturing) focus on addressing questions relating to "repair, rebuild, replace" and "was it installed correctly?" rather than "does it operate to my satisfaction" for any particular process. From my POV, performing an IQ only affects "verification of a process output" indirectly... because variation in a process outcome could come from uneven (or unspecified) installation factors. I'm not arguing against IQs, just that I think many folks have adopted a simplistic view of "IQ/OQ/PQ".

Put another way: I would NEVER believe a process was validated if there was only an IQ, but I likely could be convinced a process had reasonably understood outputs even without a formal IQ.... for some processes. The other thing I see people discuss about IQs is that these are often treated as requiring "IQ protocols"... but in an IQ it is VERY rare that any "installation requirement" is actually challenged(*1), usually IQs are just recording details of the installation(*2).

(*1) I can see some equipment being challenged with variable inputs during an IQ, but the types of equipment that come to mind would have standard test methods to test broad functionality to identify bad installs... such as HEPA systems in a clean room. In contrast would never bother with boundary testing of line-voltage requirements for a piece of equipment, as opposed to operator-set equipment parameters for a manufacturing process that absolutely would be challenged.

(*2) I don't think I've ever written, executed, or reviewed an IQ that involved anything like a sampling plan for example, something that is a key feature of OQ and PQ.

Temperature mapping is, I suppose enough of a general purpose concern for a cooler or oven, but if temperatures are changed for different processes I feel like it is the process qualification that bears the burden of understanding that the EQ is behaving as required, for the process.

 

[Milas]

I prefer that IQs (in medical device manufacturing) focus on addressing questions relating to "repair, rebuild, replace" and "was it installed correctly?" rather than "does it operate to my satisfaction" for any particular process. From my POV, performing an IQ only affects "verification of a process output" indirectly... because variation in a process outcome could come from uneven (or unspecified) installation factors. I'm not arguing against IQs, just that I think many folks have adopted a simplistic view of "IQ/OQ/PQ".

Put another way: I would NEVER believe a process was validated if there was only an IQ, but I likely could be convinced a process had reasonably understood outputs even without a formal IQ.... for some processes. The other thing I see people discuss about IQs is that these are often treated as requiring "IQ protocols"... but in an IQ it is VERY rare that any "installation requirement" is actually challenged(*1), usually IQs are just recording details of the installation(*2).

(*1) I can see some equipment being challenged with variable inputs during an IQ, but the types of equipment that come to mind would have standard test methods to test broad functionality to identify bad installs... such as HEPA systems in a clean room. In contrast would never bother with boundary testing of line-voltage requirements for a piece of equipment, as opposed to operator-set equipment parameters for a manufacturing process that absolutely would be challenged.

(*2) I don't think I've ever written, executed, or reviewed an IQ that involved anything like a sampling plan for example, something that is a key feature of OQ and PQ.

Temperature mapping is, I suppose enough of a general purpose concern for a cooler or oven, but if temperatures are changed for different processes I feel like it is the process qualification that bears the burden of understanding that the EQ is behaving as required, for the process.

Thank you

 

[Milas]

Hi

Quick follow up question

Do IQs need to be performed on hand-tools as well ad jigs & fixtures, which will be used for assembly purposes ?

Thanks