Regulatory Open Forum

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Excellent Edwin. Thanks for clarifying the concept.

How we can do EQ?
Please give some examples

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Probably the best description is the US FDA 21 CFR 820.70 (g) regulation, which is similar to ISO 13485 7.5.6 and 6.3,  where it states "Each manufacturer shall ensure that ALL equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use."  This description is a little more complete than IQ in Process Validation GHTF guidance, but again a little more information that you must complete.

Installation of the equipment includes things like is the electrical service adequate and does it meet the requirements of the equipment manufacturer, similar to other services like air and water.  Does the equipment have everything it needs to function properly, according to the manufacturer's instruction.  Is it included in your maintenance system, and do you have all the needed items to service the equipment.  What is the recommended operation of the equipment? 40 hours per week or some other period?  Is this how you will operate it?  If you are operating different from the manufacturer recommendation then you have to adjust your maintenance appropriately.  When you have it properly installed you need to verify it operates as designed and that it meets your requirements.  Have all concerned with he equipment been properly trained in its operation and maintenance?   There requirements apply to all equipment as well as the addition sub-paragraphs 1,2,3 under 820 70 (g) on maintenance, inspection, and adjustment of equipment.  

Hope this helps.  The FDA regulation is available online for free with a simple search of 21 CFR 820 on your browser, where the ISO 13485 standard must be purchased from your standards provided, if you do not already have a copy. 

By the way, equipment used in inspection, testing, and measurement  during manufacturing falls in this process as well as it is "equipment used in the manufacturing process".  Additional requirements for calibration of this equipment applies as described in 21 CFR 820.72 and ISO 13485 7.6

IQ in Process Validation is similar but only applies to equipment used in processes that are to be validated.  You might be able to write a single procedure for both, but EQ applies to all equipment used in manufacturing while IQ only apples to the equipment used in the Process Validation activities, and has a little more detail.

Excellent Edwin. Thanks for clarifying the concept.

How we can do EQ?
Please give some examples

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

In addition to all the good things Ed cited, I recommend to my clients that they also include the OSHA requirements on Lock-out/tag-out as well as the requirements for machine guarding.

These are most easily done during installation. They protect the health and safety of employees and can prevent large OSHA fines.

There are probably similar regulations outside the US.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 13-May-2024 10:15
From: Edwin Bills
Subject: IQ/OQ/PQ

Probably the best description is the US FDA 21 CFR 820.70 (g) regulation, which is similar to ISO 13485 7.5.6 and 6.3,  where it states "Each manufacturer shall ensure that ALL equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use."  This description is a little more complete than IQ in Process Validation GHTF guidance, but again a little more information that you must complete.

Installation of the equipment includes things like is the electrical service adequate and does it meet the requirements of the equipment manufacturer, similar to other services like air and water.  Does the equipment have everything it needs to function properly, according to the manufacturer's instruction.  Is it included in your maintenance system, and do you have all the needed items to service the equipment.  What is the recommended operation of the equipment? 40 hours per week or some other period?  Is this how you will operate it?  If you are operating different from the manufacturer recommendation then you have to adjust your maintenance appropriately.  When you have it properly installed you need to verify it operates as designed and that it meets your requirements.  Have all concerned with he equipment been properly trained in its operation and maintenance?   There requirements apply to all equipment as well as the addition sub-paragraphs 1,2,3 under 820 70 (g) on maintenance, inspection, and adjustment of equipment.  

Hope this helps.  The FDA regulation is available online for free with a simple search of 21 CFR 820 on your browser, where the ISO 13485 standard must be purchased from your standards provided, if you do not already have a copy. 

By the way, equipment used in inspection, testing, and measurement  during manufacturing falls in this process as well as it is "equipment used in the manufacturing process".  Additional requirements for calibration of this equipment applies as described in 21 CFR 820.72 and ISO 13485 7.6

IQ in Process Validation is similar but only applies to equipment used in processes that are to be validated.  You might be able to write a single procedure for both, but EQ applies to all equipment used in manufacturing while IQ only apples to the equipment used in the Process Validation activities, and has a little more detail.

Excellent Edwin. Thanks for clarifying the concept.

How we can do EQ?
Please give some examples

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hello Dan, 

Is there any Standard, we need to comply for OHSA?

If we don't do, what are the consequences?

what are OSHA requirements on Lock-out/tag-out ?

How it can help in EQ or IQ/OQ/PQ?

Thanks

In addition to all the good things Ed cited, I recommend to my clients that they also include the OSHA requirements on Lock-out/tag-out as well as the requirements for machine guarding.

These are most easily done during installation. They protect the health and safety of employees and can prevent large OSHA fines.

There are probably similar regulations outside the US.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 13-May-2024 10:15
From: Edwin Bills
Subject: IQ/OQ/PQ

Probably the best description is the US FDA 21 CFR 820.70 (g) regulation, which is similar to ISO 13485 7.5.6 and 6.3,  where it states "Each manufacturer shall ensure that ALL equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use."  This description is a little more complete than IQ in Process Validation GHTF guidance, but again a little more information that you must complete.

Installation of the equipment includes things like is the electrical service adequate and does it meet the requirements of the equipment manufacturer, similar to other services like air and water.  Does the equipment have everything it needs to function properly, according to the manufacturer's instruction.  Is it included in your maintenance system, and do you have all the needed items to service the equipment.  What is the recommended operation of the equipment? 40 hours per week or some other period?  Is this how you will operate it?  If you are operating different from the manufacturer recommendation then you have to adjust your maintenance appropriately.  When you have it properly installed you need to verify it operates as designed and that it meets your requirements.  Have all concerned with he equipment been properly trained in its operation and maintenance?   There requirements apply to all equipment as well as the addition sub-paragraphs 1,2,3 under 820 70 (g) on maintenance, inspection, and adjustment of equipment.  

Hope this helps.  The FDA regulation is available online for free with a simple search of 21 CFR 820 on your browser, where the ISO 13485 standard must be purchased from your standards provided, if you do not already have a copy. 

By the way, equipment used in inspection, testing, and measurement  during manufacturing falls in this process as well as it is "equipment used in the manufacturing process".  Additional requirements for calibration of this equipment applies as described in 21 CFR 820.72 and ISO 13485 7.6

IQ in Process Validation is similar but only applies to equipment used in processes that are to be validated.  You might be able to write a single procedure for both, but EQ applies to all equipment used in manufacturing while IQ only apples to the equipment used in the Process Validation activities, and has a little more detail.

Excellent Edwin. Thanks for clarifying the concept.

How we can do EQ?
Please give some examples

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

OSHA has a set of regulations, which they call standards.

29 CFR 1910.147 - The control of hazardous energy (lockout/tagout).

29 CFR 1910.147 App A - Typical minimal lockout procedures

29 CFR 1910 Subpart O - Machinery and Machine Guarding

The OSHA standards are required in the US.

These two standards are most easily implemented during installation. For example, during installation you will learn all power sources to the machine (electricity, compressed air, etc.) , so that is the best time to document the lockout/tagout plan. Similarly for machine guarding.

The goal is operator safety. You do not want an operator maimed or killed because you failed to take these basic steps.

OSHA performs inspections and can cite your company for violations. Unlike FDA, OSHA is quick to levy fines. I haven't checked the data in a few years, but, as I recall, annul fines to manufacturers run around five million dollars for each of the regulations.

There are also financial issues related to insurance and to worker's compensation.

Equipment installations (EQ & IQ) should also include these regulations.

Hello Dan, 

Is there any Standard, we need to comply for OHSA?

If we don't do, what are the consequences?

what are OSHA requirements on Lock-out/tag-out ?

How it can help in EQ or IQ/OQ/PQ?

Thanks

In addition to all the good things Ed cited, I recommend to my clients that they also include the OSHA requirements on Lock-out/tag-out as well as the requirements for machine guarding.

These are most easily done during installation. They protect the health and safety of employees and can prevent large OSHA fines.

There are probably similar regulations outside the US.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 13-May-2024 10:15
From: Edwin Bills
Subject: IQ/OQ/PQ

Probably the best description is the US FDA 21 CFR 820.70 (g) regulation, which is similar to ISO 13485 7.5.6 and 6.3,  where it states "Each manufacturer shall ensure that ALL equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use."  This description is a little more complete than IQ in Process Validation GHTF guidance, but again a little more information that you must complete.

Installation of the equipment includes things like is the electrical service adequate and does it meet the requirements of the equipment manufacturer, similar to other services like air and water.  Does the equipment have everything it needs to function properly, according to the manufacturer's instruction.  Is it included in your maintenance system, and do you have all the needed items to service the equipment.  What is the recommended operation of the equipment? 40 hours per week or some other period?  Is this how you will operate it?  If you are operating different from the manufacturer recommendation then you have to adjust your maintenance appropriately.  When you have it properly installed you need to verify it operates as designed and that it meets your requirements.  Have all concerned with he equipment been properly trained in its operation and maintenance?   There requirements apply to all equipment as well as the addition sub-paragraphs 1,2,3 under 820 70 (g) on maintenance, inspection, and adjustment of equipment.  

Hope this helps.  The FDA regulation is available online for free with a simple search of 21 CFR 820 on your browser, where the ISO 13485 standard must be purchased from your standards provided, if you do not already have a copy. 

By the way, equipment used in inspection, testing, and measurement  during manufacturing falls in this process as well as it is "equipment used in the manufacturing process".  Additional requirements for calibration of this equipment applies as described in 21 CFR 820.72 and ISO 13485 7.6

IQ in Process Validation is similar but only applies to equipment used in processes that are to be validated.  You might be able to write a single procedure for both, but EQ applies to all equipment used in manufacturing while IQ only apples to the equipment used in the Process Validation activities, and has a little more detail.

Excellent Edwin. Thanks for clarifying the concept.

How we can do EQ?
Please give some examples

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hello Dan, 

Thanks for detailed answers.

OHSA requirements are only applicable in US, correct?

Do we need LOTO procedures for Canadian Medical Devices Manufacturer?

Thanks

OSHA has a set of regulations, which they call standards.

29 CFR 1910.147 - The control of hazardous energy (lockout/tagout).

29 CFR 1910.147 App A - Typical minimal lockout procedures

29 CFR 1910 Subpart O - Machinery and Machine Guarding

The OSHA standards are required in the US.

These two standards are most easily implemented during installation. For example, during installation you will learn all power sources to the machine (electricity, compressed air, etc.) , so that is the best time to document the lockout/tagout plan. Similarly for machine guarding.

The goal is operator safety. You do not want an operator maimed or killed because you failed to take these basic steps.

OSHA performs inspections and can cite your company for violations. Unlike FDA, OSHA is quick to levy fines. I haven't checked the data in a few years, but, as I recall, annul fines to manufacturers run around five million dollars for each of the regulations.

There are also financial issues related to insurance and to worker's compensation.

Equipment installations (EQ & IQ) should also include these regulations.

Hello Dan, 

Is there any Standard, we need to comply for OHSA?

If we don't do, what are the consequences?

what are OSHA requirements on Lock-out/tag-out ?

How it can help in EQ or IQ/OQ/PQ?

Thanks

In addition to all the good things Ed cited, I recommend to my clients that they also include the OSHA requirements on Lock-out/tag-out as well as the requirements for machine guarding.

These are most easily done during installation. They protect the health and safety of employees and can prevent large OSHA fines.

There are probably similar regulations outside the US.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 13-May-2024 10:15
From: Edwin Bills
Subject: IQ/OQ/PQ

Probably the best description is the US FDA 21 CFR 820.70 (g) regulation, which is similar to ISO 13485 7.5.6 and 6.3,  where it states "Each manufacturer shall ensure that ALL equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use."  This description is a little more complete than IQ in Process Validation GHTF guidance, but again a little more information that you must complete.

Installation of the equipment includes things like is the electrical service adequate and does it meet the requirements of the equipment manufacturer, similar to other services like air and water.  Does the equipment have everything it needs to function properly, according to the manufacturer's instruction.  Is it included in your maintenance system, and do you have all the needed items to service the equipment.  What is the recommended operation of the equipment? 40 hours per week or some other period?  Is this how you will operate it?  If you are operating different from the manufacturer recommendation then you have to adjust your maintenance appropriately.  When you have it properly installed you need to verify it operates as designed and that it meets your requirements.  Have all concerned with he equipment been properly trained in its operation and maintenance?   There requirements apply to all equipment as well as the addition sub-paragraphs 1,2,3 under 820 70 (g) on maintenance, inspection, and adjustment of equipment.  

Hope this helps.  The FDA regulation is available online for free with a simple search of 21 CFR 820 on your browser, where the ISO 13485 standard must be purchased from your standards provided, if you do not already have a copy. 

By the way, equipment used in inspection, testing, and measurement  during manufacturing falls in this process as well as it is "equipment used in the manufacturing process".  Additional requirements for calibration of this equipment applies as described in 21 CFR 820.72 and ISO 13485 7.6

IQ in Process Validation is similar but only applies to equipment used in processes that are to be validated.  You might be able to write a single procedure for both, but EQ applies to all equipment used in manufacturing while IQ only apples to the equipment used in the Process Validation activities, and has a little more detail.

Excellent Edwin. Thanks for clarifying the concept.

How we can do EQ?
Please give some examples

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Probably the best description is the US FDA 21 CFR 820.70 (g) regulation, which is similar to ISO 13485 7.5.6 and 6.3,  where it states "Each manufacturer shall ensure that ALL equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use."  This description is a little more complete than IQ in Process Validation GHTF guidance, but again a little more information that you must complete.

Installation of the equipment includes things like is the electrical service adequate and does it meet the requirements of the equipment manufacturer, similar to other services like air and water.  Does the equipment have everything it needs to function properly, according to the manufacturer's instruction.  Is it included in your maintenance system, and do you have all the needed items to service the equipment.  What is the recommended operation of the equipment? 40 hours per week or some other period?  Is this how you will operate it?  If you are operating different from the manufacturer recommendation then you have to adjust your maintenance appropriately.  When you have it properly installed you need to verify it operates as designed and that it meets your requirements.  Have all concerned with he equipment been properly trained in its operation and maintenance?   There requirements apply to all equipment as well as the addition sub-paragraphs 1,2,3 under 820 70 (g) on maintenance, inspection, and adjustment of equipment.  

Hope this helps.  The FDA regulation is available online for free with a simple search of 21 CFR 820 on your browser, where the ISO 13485 standard must be purchased from your standards provided, if you do not already have a copy. 

By the way, equipment used in inspection, testing, and measurement  during manufacturing falls in this process as well as it is "equipment used in the manufacturing process".  Additional requirements for calibration of this equipment applies as described in 21 CFR 820.72 and ISO 13485 7.6

IQ in Process Validation is similar but only applies to equipment used in processes that are to be validated.  You might be able to write a single procedure for both, but EQ applies to all equipment used in manufacturing while IQ only apples to the equipment used in the Process Validation activities, and has a little more detail.

Excellent Edwin. Thanks for clarifying the concept.

How we can do EQ?
Please give some examples

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Excellent - thanks for the clarification

Probably the best description is the US FDA 21 CFR 820.70 (g) regulation, which is similar to ISO 13485 7.5.6 and 6.3,  where it states "Each manufacturer shall ensure that ALL equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use."  This description is a little more complete than IQ in Process Validation GHTF guidance, but again a little more information that you must complete.

Installation of the equipment includes things like is the electrical service adequate and does it meet the requirements of the equipment manufacturer, similar to other services like air and water.  Does the equipment have everything it needs to function properly, according to the manufacturer's instruction.  Is it included in your maintenance system, and do you have all the needed items to service the equipment.  What is the recommended operation of the equipment? 40 hours per week or some other period?  Is this how you will operate it?  If you are operating different from the manufacturer recommendation then you have to adjust your maintenance appropriately.  When you have it properly installed you need to verify it operates as designed and that it meets your requirements.  Have all concerned with he equipment been properly trained in its operation and maintenance?   There requirements apply to all equipment as well as the addition sub-paragraphs 1,2,3 under 820 70 (g) on maintenance, inspection, and adjustment of equipment.  

Hope this helps.  The FDA regulation is available online for free with a simple search of 21 CFR 820 on your browser, where the ISO 13485 standard must be purchased from your standards provided, if you do not already have a copy. 

By the way, equipment used in inspection, testing, and measurement  during manufacturing falls in this process as well as it is "equipment used in the manufacturing process".  Additional requirements for calibration of this equipment applies as described in 21 CFR 820.72 and ISO 13485 7.6

IQ in Process Validation is similar but only applies to equipment used in processes that are to be validated.  You might be able to write a single procedure for both, but EQ applies to all equipment used in manufacturing while IQ only apples to the equipment used in the Process Validation activities, and has a little more detail.

Excellent Edwin. Thanks for clarifying the concept.

How we can do EQ?
Please give some examples

There are a lot of misinterpretations in the responses here. AAMI has a course on Process Validation you may want to take, it is done virtually so it is available anywhere you are located.

As mentioned in one of the posts, for medical devices there is a great GHTF guidance on Process Validation for medical devices including IVDs which is the IQ,OQ,PQ process you asked about. This only applies to processes which require Process Validation. The guidance helps you determine which processes must be validated  

The point of apparent confusion here is that ALL equipment used in manufacturing requires Qualification, often referred to as Equipment Qualification to assure it is installed correctly and has the necessary inputs such as electrical power, air supply, and necessary water and any other services such as necessary maintenance to perform as required. ALL equipment requires Equipment Qualification. 

IQ, OQ, PQ are elements of Process Validation which are applied as described in the mentioned GHTF guidance. Not all processes require Process Validation, but it is applied as described in the guidance.  IQ and EQ are very similar processes which may lead to confusion.  IQ is Installation Qualification, which assures equipment used in Orocess Validation is installed correctly and has required inputs. OQ is Operational Qualification and helps establish the ability of a process to produces product meeting specifications.  PQ is Process Qualification which assures a Process will operate over a longer term producing Product that meets requirements. 

So, all Equipment you use in production requires EQ. All Processes which require Validation require IQ, OQ, and PQ. Additionally all equipment used to make any measurements for Verification, including Design Verification, Incoming Inspection, In-process Inspection, and especially Final Acceptance require EQ AND Calibration. 

Just to add to confusion the above is for medical devices including IVDs. If you are in drugs or biological, US FDA has a process validation guidance for those products. 

If you are in the US (or sell into the US), this is the FDA's position on process validations:

iii. Process Validation (Sec. 820.75)

    143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted.    In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *'' Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?

Hi Anon,

We can support you with process validation for medical device manufacturing. Cencora PharmaLex is one of the largest global regulatory solutions providers for Pharma, Biotech, and MedTech companies, with offices in over 60 countries around the globe. We can provide solutions at whatever stage of development or commercialization you're at in the product lifecycle. I'd be happy to discuss your needs further or connect you with the appropriate subject matter experts here at Cencora PharmaLex.  Please let me know what the best way to connect with you is, and we can set up a call.

Hello Validation Experts, 

Could anyone please simple rule which equipment's require IQ, OQ and PQ in a small medical devices manufacturing company?

Do we need perform for every machine in the plant such as welding machine, CNC machines, forklifts, drilling machines, milling machines?

And how about those machines, which are in currently from so long time?

How IQ/OQ/PQ are different then machine maintenance stuff?