Re: QSR820.120 labeling and packaging control
It is a Blood pressure monitor.
Could you give me some suggestions about how to establish the labeling and packaging procedure?
Hi Celia,
First, consider labels and labeling, and packaging the same as any other component for the device - they're subject to your design control system. In other words, include your labeling requirements in your requirements documents, create specifications for them, validate them, etc.
There are general and specific requirements for the information FDA expects to see on packaging and labeling under 21CFR801. In general, FDA requires much of the same information as other countries... name of business, location, intended use, instructions for use, etc. are required for all devices.
See also
http://www.fda.gov/cdrh/devadvice/331.html
Also consider the required labeling for your device. A Blood Pressure monitor is an over the counter (non-prescription) device. There are specific labeling requirements for OTC devices. If the device has been cleared on a 510(K), your labeling statements have already been reviewed by FDA when you submitted your 510(K), but be sure that your packaging is designed to meet the requirements at 21CFR801.60, 801.61 and 801.62.
See also
http://www.fda.gov/cdrh/devadvice/3311.html
Then, you need to control packaging and labeling operations in production. I asked what kind of device you were dealing with to determine the level of control you'd want for your packaging / labeling operations. I've worked at companies that controlled labeling like Fort Knox, where other companies didn't need the same stringent controls.
Your procedures for control of packaging and labeling should be appropriate for your device.
Labeling in manufacturing operations extends beyond the labels that go onto your device. Labeling will include ID tags, and labels on equipment, and any labeling used in the manufacturing of the device as well as on the device itself. You don't need to go crazy developing a master labeling control plan for your type of device, but you need to make sure that labels are designed appropriately for the device and in accordance with the requirements above, and that they are inventory controlled (e.g. issued and tracked through production).
You'll want to establish labeling review and approval requirements, and address things such as incoming inspection, proper application, over-labeling, etc.
In your case, I would suggest paying closer attention to how labels/labeling are designed, and how they're reviewed / approved, and inspected, but you need to control labeling activities throughout the organization. Something like this:
- Include labeling design requirements in your design control system. You should have some general labeling requirements written into your system. (e.g. labels shall be designed to remain legible for the life of the product.... etc.)
- Include labeling changes in your document control system (some companies create a separate doc control just for labels)
- Make sure that Regulatory Affairs is included in the review and approval of labeling
- Establish inspection requirements for first articles and incoming inspection. This can be done as a separate labeling inspection procedure, or by your general inspection procedure with your typical sampling plans and inspection criteria. Make sure you include proof reading as part of your incoming inspection. This can be done with transparancies or actual proof-read
- Make sure your inventory control procedures - storage / handling, etc. include instructions for the storage of labeling. If you have pre-printed serial numbers or lot numbers for the wrap on labels, describe how they will be issued.
- Part of your normal manufacturing process most-likely already includes the application of labeling. If not... be sure that it does.
- Your calibration system should include requirements defining how your calibrated equipment is labeled.
- If you use status labeling through inventory control and manufacturing, you'll need to define the labeling in your procedures. You'll use the same controls for status labeling that you'd use for device labeling. In other words, status labels (e.g. accepted, rejected, pass, fail, etc) should be designed to be legible, remain affixed, and perform as intended. Maintain the same controls relative to over-labeling, destruction of labels, etc. that you would for your device labeling.
- Make sure your rework procedures address how labels are handled. If they have to be removed and replace, what's your policy?
- Make sure your nonconforming material system addresses how labels will be handled if they are scrapped. What steps will you take to prevent the possible mis-use of rejected / scrapped labels? How will labels be segregated to prevent mis-use? If scrapped, how will they be discarded? They should be somehow obliterated or destroyed to prevent any possibility of misuse.
I may have missed some points here... This is off the top of my head, and as you can see will vary from company to company. The one thing to keep in mind is that with a device like yours, the design and content of the labels, and how you control rejects is more important than controlling the quantity issued. Some companies need to control labels so stringently, they keep them locked in separate inventory cages within secured warehouses. Then when they issue them, they're double-counted and countersigned. You wouldn't need to do anything like that. Again, it's all very specific to the type of device you're manufacturing. Focus on making sure you show strength in design, review / approval, handling changes, incoming inspection, and a little emphasis on scrapped labels. The rest you can handle like any other inventory really.
A really great explanation of the quality system requirements for labeling can be found here:
http://www.fda.gov/cdrh/devadvice/334.html
I hope I didn't confuse matters more for you. Read the links, and I'm sure you'll get a better picture of this. Be sure to consult with your regulatory affairs manager, though. That person is a significant stakeholder in all things related to labeling.