We are a small company, which coats intraocular lenses. This medical device is sold to a US company. The Company sterilizes the product and sells the product to the customer (eye specialist).For how long time should our company retain the quality record?

Which quality record? You probably have more than 1.

Dear marc,

All the Quality records that are mentioned in ISO 9001

Best regards
Monica

ISO9001 does not specify particular records other than to say you have to identify those records your company believes affect quality. I don't have any FDA regs here nor is it my specialty so I don't know if they give any specific times - But ISO9001 does not specify retention times.

In short, your company should have a list of what it considers 'quality records' and each record must have a designated retention time - which your company also determines. Be ready to discuss why your company chose the retention time for each record.

Does that help?

21 CFR 820.180(b) states "All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer." If, as stated, you supply product to another party, I would think that, as a minimum, that two years would be required. Be sure to justify by objective evidence the reasoning for this decision. Hope this helps.

Dear Don and Marc,

Thanks for answering my question.

Marc according to ISO 9001, I can come up with the following records that are required:

Management review (4.1.3)
Quality planing (4.2.3 h)
Records of contract review (4.3.4)
Records of design review (4.4.6)
Records of design verification measures (4.4.7)
Quality records of acceptable subcontractors (4.6.2c)
Records for damage, loss of customer supplied products (4.7)
Product identification (4.8)
Records for any qualification of process operations etc (4.9)
Where in coming products is released (4.10.2.3 This may not be required)
Records identifying the inspection authority responsible for the release of produc(4.10.5)
Records regarding the extent and frequency of control of inspection (4.11.1)
Calibration records (4.11.2 e)
Record for the description of the nonconformity etc (4.13.2)
Investigation records (4.14.2)
Records of internal audits (4.17)
Training records (4.18)

Did I do my math well?

Pretty much so - looks like a fine list to me - But there *may* be other records in your company.

When I work with a company in compliance one of the first things I do is ask them to take a DETAILED tour of the company at large and make a list of all the paperwork they find taking a copy of each as it is found.

Then comes categorizing and matrixing the documents. The intent is a 'discovery' of all the types of documents in the company.

So in short - yoiur list may serve as a minimum (ISO9001 wise) but does not preclude others.

Monica,

Marc is very correct. Your list is complete as far as ISO 900x is concerned. But, the QSR is more stringent than ISO in some areas. It should be prudent to review the QSR, cross tab to ISO and tailor your system to that. The system in place at my firm incorporates the most comprehensive clauses from each (covered on both bases).

As an addendum to my previous post. I do not know the details of your firm's business. The records required shall be for the life of the device but in no case less than two years. Under the assumption you supply a customer (as a vendor) and not an end user, two years should be sufficient. I have *.pdf and *.doc of many publications from the CDRH, if you would like copies, please me know.

Don

Don,

Iwould like to have a copy of publications from the CDRH

Monica

I would like copies as well..if you would
Or perhaps you could post them here in *.pdf world.

thanks
Barb

I have collected three or four dozen documents that refer to the CDRH in particular and the FDA in general. Is there anything in particular you have interest in? If Marc is interested, I could forward to him to post on His board.
Don

Send 'em - I'll post 'em.

Marc, I will forward as I get them into an organized structure. Please watch.

Marc, publications are on their way.

Nothing like re-opening a discussion that's over three years old but.........

When my company was audited by our customer (this is for the manufacture of a medical device), the topic of record retention period came up.

When I asked the auditors what the retention time period was for FDA records, they shuffled around and eventually came up with "...retained for the expected life of the product plus two years seven from the date of release for commercial distribution."

This doesn't exactly seem to 'jive' with what is stated in CFR 820.180(b). When asked what FDA document those numbers were derived from, all I got were hems and haws and "we'll look into it and get back to you" (I'm still waiting since early December 2001).

So the question on the table is, Is there an official FDA document that specifies record retention period besides CFR 820.180(b) or were they just giving me their "sacred" interpretation of what they "think" FDA really wants?:confused:

RCW,

It appears to me like they gave you the "I'll get back to you..." but don't really hope to. I recently got back into the medical device world and all my literature is at my desk at work. If I think of it on Monday, I'll give it a look and get back to you (I'll need to know this too, so we'll give this three-plus year old discussion new life).

Regards,

Kevin

Originally posted by RCW
retained for the expected life of the product plus two years seven from the date of release for commercial distribution."

That is the basic time period presumed in the Pharmaceutical Industry, although some companies keep their records for 75+ years... the average lifetime of potential consumers. You never know when you might be sued.
The actual requirement, again for Pharmaceuticals (not devices), is stated in CFR 211.180, Subpart J as "..at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating..., 3 years after distribution of the batch." I would presume that the requirements for medical devices would be similar, and could be found in the cGMP's for medical devices.


CFR=Code of Federal Regulations
OTC=over the counter
cGMP=current good manufacturing practices

RCW-

It may have been said previously but it's up to you to decide, define and document the 'life of the product.' Some have suggested that it could be as little as the length of the warranty but many companies have a problem with that (me too).

There may be another consideration for you, also. If you sell your medical devices in Europe (or intend to) you need to check the Medical Device Directive. In Annex II (start with paragraph 6.1) you'll find requirements for a five year retention time.

My understanding is that most companies that manufacture class I or lower risk class II devices settle on about seven years.

Alf

Thanks for the information, guys.

Kev

It may have been said previously but it's up to you to decide, define and document the 'life of the product.'

I don't think my company is in the position to make the decision seeing we are 'contract manufacturers' for the product. My company also isn't responsible for outside sales either, only directly to our customer (the holder of the design rights).

I was just seeking an FDA gudeline so I could see if my customer is feeding me a line of paranoidal b.s.

I don't directly deal with supplier/customer relationships or contract manufacturing but it might just be a case of "[your] customer is always right." If they define 'life' as seven years, or just demand retention as a part of your service, you probably have to do it.

On the plus side, it's all those medical device requirements that keeps the competition down.

For us it means a lot of cardboard 'banker's boxes' to hold the records.

Alf

I too am intwerested in this thread, extra info. I service amd MFG several medical companies like Inviro, BD here at this plant. We deal with 3-4 more medical companies in our Janpan plants. The more I learn the better off we become as a team.:p :smokin:

Dear Monica!!

Take into account that FDA look for legal compliance and productor responsibilities.
In case of liabilities with your product (such defects during use or others) your records are your protection against enforcement. (Look case Johnson with Tylenol).

Again, you must to keep your record during at least the shelf life of your product plus normaly one or two years.
Is on your interest, not in the registration of QMS.

Good luck

As a contract manufacturer of medical devices, we have been 'round and round' on this topic. Our customers have never informed us of the life of the products we manufacture for them, and haven't responded on the subject when we have asked them directly. So, I have sent out a letter stating that we retain records for seven years and asked that they sign if they approve of the policy. I will report back as to how the letter is received.

Monica,

Intraocular lenses are medical devices that due to the nature of their production process and packaging, contain an expiration date. Expiration dating for these types of devices, by manufacturer can be attained on the FDA's CDRH MAUDE web site by reviewing the regulatory approval letter sent by the FDA to the company in order to market the product. Depending on the device, check either under the PMA or 510K section by company name.

For your part, unless you can demonstrate otherwise, you'll need to use the expiration duration (generally 3 years) from the company you sell to, then add the 2 years beyond that. Most company's use a 3 year expiry because the stability studies (even accelerated) to go longer generally take longer then the product life cycle before it needs to be changed.

The Q records that have to be retained would be anything that demonstrates the the methods of quality and control for the activities that your company provides. Things like raw material receipt and approval, processing records, testing records, calibration records, and relevant employee training on how to do all of the above. Key to this is having a clear specification for shipment that has acceptance limits, test methods, and sampling plans included.

Because IO lenses are implantable devices, the supplier assurance program of your customer should be under pretty tight scrutiny from their compliance department. You may want to draft a list of what you consider to be the documentation and for what duration your company will retain it, and then secure agreement with your customer's QA group. That way there's no confusion should an issue occur downstream.

Dave Gronostajski

From the preamble:
"181. A few comments on Sec. 820.180(b), ``Record retention period,'' stated that the section should be amended because all quality records may not be tied to a specific device; therefore, such quality records may not need to be maintained over the lifetime of a device. A few comments stated that the retention period requirement is unclear and burdensome, while others stated that the period should be left to the manufacturer to define. One comment suggested the deletion of the requirements related to photocopying records in proposed Sec. 820.180(b) because it is technology that is not necessarily being used.
FDA believes that all records should be retained for a period equivalent to the design and expected life of the device, but in no case less than 2 years, whether the records specifically pertain to a particular device or not. The requirement has been amended to make clear that all records, including quality records, are subject to the requirement. FDA believes this is necessary because manufacturers need all such records when performing any type of investigation. For example, it may be very important to access the wording of a complaint handling procedure at the time a particular complaint came in when investigating a trend or a problem that extends to several products or over an extended period of time. Further, FDA does not believe that allowing the manufacturer to define the retention period will serve the public's best interest with regard to safety concerns and hazard analysis."

Note the regulation states design AND expected life of the device, but in no case less than 2 years.

In addition section Sec. 820.186 Quality system records add additional requirments.

In most cases this means QS record retention beyond shelf life. The regulation is very specific about what records to keep just do a quick search for shall be documented on the attached file.
:bonk: