Hi All:

Can anybody help me with templates specific to the Medical Device industry as pertains to "commissioning" activities? We are under 13485 and QSR and need a Quality Plan, Facility Transfer Plan, and IQ/OQ/PQ templates related to a new facility.

I think I have the basics since I used to work under 21 CFR 210, but I also need some tips as to what FDA's expectations are for the device side.

We have no sterile operations or cleanrooms, just a clean Class 2 facility.

Thanks!!!
Madly RA'd

Hi All:

Can anybody help me with templates specific to the Medical Device industry as pertains to "commissioning" activities? We are under 13485 and QSR and need a Quality Plan, Facility Transfer Plan, and IQ/OQ/PQ templates related to a new facility.

I think I have the basics since I used to work under 21 CFR 210, but I also need some tips as to what FDA's expectations are for the device side.

We have no sterile operations or cleanrooms, just a clean Class 2 facility.

Thanks!!!
Madly RA'dMedical Device inspection is not the same as pharmaceutical. Look at the QSIT Guide (http://elsmar.com/Forums/attachment.php?attachmentid=2418) and I (http://www.fda.gov/cdrh/comp/guidance/7382.845.html#p3)nspection of Medical device Manufacturers (http://www.fda.gov/cdrh/comp/guidance/7382.845.html)for a level 2 inspection.

Hi Al:

I checked your references again, but didn't find the specifics that I am looking for. Can you be more specfic?

Thanks!
Laura

Hi Al:

I checked your references again, but didn't find the specifics that I am looking for. Can you be more specfic?

Thanks!
LauraLet's review each of your requirements.

Quality Plan: Your Quality Manual that describes your relevant design and manufacturing quality practices, resources and activities and how you intend to meet your quality requirements.

Facility Transfer Plan: I don't know what this is since I have never seen one for MEDDEVS. Could this be unique to pharma?

IQ/OQ/PQ templates related to a new facility: See the attached file, do a search within the cove ( I think some of this has been discussed) and also look at clinivation.com. (http://www.clinivation.com/pages/resources/downloads.php)

Hi Al:

I checked your references again, but didn't find the specifics that I am looking for. Can you be more specfic?

Thanks!
Laura

You may also want to refer to GHTF documents website for more information - www.ghtf.org and look for GHTF documents.

This gives some very good guidance on proceeding with documents for medical devices.

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

I agree with the other posters, in that medical device regulations are not the same as phama regulations.

I want to comment about pharma v. device regulations and personnel.

I have seen many quality problems, especially in the areas of design controls, CAPA, process validation, and change control because ex-pharma managers/ personnel are now employed at medical device companies. The same is true when a FDA pharma investigator inspects a medical device company.

Basically, 21 CFR 210/211 is black or white (such as pertaining to process validation or acceptance testing); whereas 21 CFR 820 is grey in certain areas (such as noted above).

Pharma people do not understand various medical device concepts (such as process validation, design controls, change control, or statistical techniques). If a pharma person is the management rep or the qualified validation person, he/she better understand how the QSR works, else there will be issues- not only with the FDA, but with quality non-conformances as well.

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

I agree with the other posters, in that medical device regulations are not the same as phama regulations.

I want to comment about pharma v. device regulations and personnel.

I have seen many quality problems, especially in the areas of design controls, CAPA, process validation, and change control because ex-pharma managers/ personnel are now employed at medical device companies. The same is true when a FDA pharma investigator inspects a medical device company.

Basically, 21 CFR 210/211 is black or white (such as pertaining to process validation or acceptance testing); whereas 21 CFR 820 is grey in certain areas (such as noted above).

Pharma people do not understand various medical device concepts (such as process validation, design controls, change control, or statistical techniques). If a pharma person is the management rep or the qualified validation person, he/she better understand how the QSR works, else there will be issues- not only with the FDA, but with quality non-conformances as well.

I respectfully disagree with you. Pharma people very well know about concepts relating to Process validation, Design Controls, Change Control etc and Statistical techniques. (and these are not the concepts adopted by medical devices alone !)

I worked in various multinational Pharmaceutical organizations for 18 years and the degree of the topics that you mentioned is much more than is adopted by medical devices manufacturers. For the last 2 years, I am into medical devices and can see the lesser extent of validations than we did in Pharmaceuticals.

Let me clarify-

I know that 21 CFR 210/211 covers process validation, change control, etc. What I am saying is that there are differences between drug and device regs in these areas.

How many pharma people (not knowing/ understanding medical device regulations but are thrown into the world of medical devices) are able to correctly answer these questions.

1. Medical device manufacturers have to deal with PPQ (product performance qualification) when conducting process validation studies. This is not required by 21 CFR 210/211. Why do device companies have to perform this extra validation step?

2. When there are new processes or changes to these processes, medical device companies have to figure out whether the results of these processes can be fully verified by subsequent inspection and tests. If not, then the process has to be validated. Where in 21 CFR 210/211 does it give a drug company this choice? Why are medical device firms given this choice?

3. Is the 3 consecutive batch rule ok when conducting a medical device process validation study? It makes perfect sense when validating a drug mixing operation.

4. Let's use the same 3 consecutive batch rule again. If you state that you are going to sample 3 consecutive batches and test them against your written final acceptance specifications, does this activity solely constitute a design validation for the product? Is the 3 consecutive batch rule acceptable when conducting a design validation? Does this design validation sampling rule change, if the device is computer, software disk, or has a software chip?

These are just a few examples that I dealt with when I was an FDA investigator and now as a consultant inspecting medical device companies.

Of course the reverse is true when drug investigators (who do not properly understand the device regulations) inspect device companies...

Not to pick on pharma people alone... what I am getting at, is the device regulations are umbrella regulations- to cover class I products as well as class III products. Not only are these regs difficult for pharma people, but for device people as well.

I am glad this forum exists, because I hope through our posts, we show why quality is important- not only for medical device or drug companies, but other companies as well. It is good business practice to have a sound quality system in place- even if there are no governmental regulations forcing people to do so accordingly!

Here are a few horror stories because people did not understand the device regs or knew they even existed.

a. Device personnel who do not understand why they have systematic problems because they have to constantly redesign products as corrective actions to repeat service reports/complaints or have band-aid fixes which cause repeat deficiencies.

b. Business people who decide to start-up small manufacturing sites to manufacture "widgets" and do not understand they are indeed manufacturing medical devices because of the claims noted in the product labeling/ advertising.

c. Device personnel who do not understand how the process validation/ CAPA/ design control processes work and as a result have to voluntarily recall products because non-conforming products have been distributed.

d. Device personnel who do not understand why they have product non-conformances or sterilization issues because they do have strict controls in place (such as gowned up maintenance people bringing greasy tools into the clean room, hiring security guards who think it is ok to bring the security dogs into the clean rooms, allowing people to smoke/eat/drink in designated clean room and/or other production areas, or allowing birds or other animals in the warehousing areas).

e. Gas repackers who instantly became medical device companies because their sales/marketing personnel advertised/marketed, then sold certain gas combinations to hospital personnel as medical devices.

Each industry is uniquely different from the other and thus there is no exception between medical devices and drugs.

I do not see any point in highlighting the dissimilarities between device and drug. Just as you have listed the things unique to the devices, there are some aspects which are unique to drugs and not adopted for devices. For an example, it could be the "Cleaning Validation". Another could be the severity of the "Analyst Qualification" and "Stability Studies"

Just as you ask "How many pharma people (not knowing/ understanding medical device regulations but are thrown into the world of medical devices) are able to correctly answer these questions", I would ask the question vice versa, how many device people know about the drug regulations ?

Ireespective of these differences, I am trying to drive the point that the concepts like Qualification, Validation, Change Control remain the same but the degree may vary.

It would be not appropriate to say that Pharma people do not know about device regulations. :) After all, they are inter related with no major differences. If I can adapt in the new environment of devices, I think any individual from Pharma can do well :lol:

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

:topic:
You don't have to keep saying that with every post there pardner, after awhile it's like crying wolf and people will stop listening.

If you get off your pony you'll also find there are folks here that can match you tit-for-tat, so in playing the credential game you may find yourself a few points behind fairly fast.

You're sharing good information, and I have learned a thing or two, but don't turn folks off to it.

Hopefully getting back on topic:

Madly RA'd Woman,

Here's an approach I've used. Typically, I create a Quality Plan to provide the framework around how QMS activities will remain under control during the transition from one facility to another. Essentially, it's a section by section, point by point expansion on how things will remain under control and who will have primary responsibilities. For instance, how will you transition open CAPAs from one system into the other? How will you transition suppliers on one ASL to the other when there are different rating systems/criteria? The key here is to establish the plan up front to all you can anticipate and amend the plan as you uncover items that you haven't. Periodic, scheduled reviews are key to maintaining the overall integrity of the plan as well as for the QMS's in both locations while the transition occurs. The plan lives for as long as it takes to transfer activities from one location to the other. However, there are longer term considerations that need to be considered. In this instance, it's imparative to establish a Quality or Technical Agreement that will provide longer term governance over key QMS activities such as Complaint Handling and vigilance.

Regarding the Transfer Plan (we capture the transfer in what we call the Project Management Plan or Transition Plans), we typically use these to handle the business aspects and logistics involved with the move. Consider things such as how you will maintain stocking inventories (or build up safety stock), who will be responsible for key deliverables such as forcasts, material supply, etc. This plan is also short lived in that it provides governance through the transfer/transition activities and will end when activities do.

Of course, there are hosts of other smaller plans to consider such as a Documentation Transfer Plan (usually this is a project itself), Manufacturing Plans, Master Validation Plans (provided by Al), Process Validation Plans (IQ/OQ/PQ), etc. My belief is that once you have established the requirements for these activities, the development of plans with roles and responsibilities defined, governance established, and expected outputs and deliverables, you will have a smoother transfer/transition effort.

Geochaz,

In your experience, how have manufacturers faired regarding the requirements and planning activities? I'd be curious to know what FDAs perspective was regarding transitioning of lines and operations to other facilities. Was there more attention paid to the operations receiving the lines versus the operation handing it off?

Back to the group...

If processes required validation or verification at the old site, they would require re-validation or re-verification once set in place at the new site (and prior to use during normal operations). Plus, the "relocated" quality, production, or test equipment needs to be re-calibrated, re-verified, and/or re-qualified. This is to show if there were any physical/mechanical changes to the equipment as a result of the physical move.

Except for the 21 CFR 820.20(d) quality plan, I am not familiar with your planning terminologies. I believe specific project plans and schedules are usually contained in the validation/ qualification protocols or verification/ calibration procedures. Overall transfer plans can be part of the initial quality plan.

Basically, the above checks have to be performed to see the equipment/ process performed the same way as in the old facility. If not, then proper repairs, cleaning, maintenance, servicing, etc are needed and re-validations, re-verifications, re-qualifications, re-calibrations, etc repeated. If damaged beyond repair, then new equipment purchased and new validations, etc performed.

Geochaz,

I was more curious about what FDA's expectations were from a planning standpoint. Currently, we invest significant time in preparation of receiving transitioned lines and developing plans around our expected activities. We would do this anyways because as I've said, it helps all around: compliance, quality, effectiveness, efficiency. All you have described and more is involved in the efforts we've extended. The various terms/plans I've mentioned were developed over the years as we continually improved our validation efforts and to facilitate smoother transitions.

Thanks for the prompt response.

Kevin