UDI TIME SCHEDULES.

Apply for a Labeler Identification Code (LIC).


The UDI Time Schedules has identified the Health Industry Bar Code Supplier Labeling Standard (HIBC SLS) as a data standard for UDI. The FDA regulation requires a product identifier, as well as a labeler identifier.


UDI Time Schedules Questions and Answers.

  1. Does my device require the “direct marking” of the UDI number? This depends on the type of device, as all medical devices intended to be used more than once or intended to be reprocessed before each use must have direct marking of the UDI. The FDA has stated as part of the regulation that implantable devices will not require the direct marking. Single-use devices do not require direct marking of the UDI number on the device.
  2. What packaging level do I need to place the UDI on the labels? The UDI must be on each level of packaging up to shipping, which does not require the UDI number to be on the shipping box or pallet. The important thing to remember is that the UDI must be available to the user at all points of use. As an example, a carton of ten units sitting on a shelf must have the UDI number, and the individual unit from that carton being used at the patient bedside must have the UDI number.  UDI time schedules historical notes.
  3. Where do I actually get this UDI number? There are three Issuing Agencies (IA) currently accredited by the FDA that assign the Device Identifier portion of the UDI. The Device Identifier (DI) is composed of a unique company identification and a unique number assigned to each version or model of device. If a company has ten different models or versions of a device, then they would have 10 distinct DI numbers. The UDI may then be composed of the DI and the Production Identifier (PI) that includes information such as lot number, serial number, or expiration date. The FDA does not actually assign the UDI since this number is obtained from the IA and then entered into the FDA’s Global Unique Device Identification Database (GUDID).  UDI time schedules guidance.
  4. How do I get an account with the FDA for the GUDID database? Currently the FDA is only assigning GUDID accounts after these are requested through an email request from the FDA. That is, a firm must request a GUDID account on the FDA website; the FDA then sends the applicant a form to fill out. Once the applicant sends back the form to the FDA via email, the agency reviews the form, and then sends an email back to the applicant with GUDID account log-in information. In other words, it’s not like other sites where one can just “register” to set up an account. The FDA is limiting the amount of accounts being assigned currently in order to manage and build the GUDID system. Only Class III, life-sustaining, and life-supporting devices are being provided GUDID accounts. No Class II or Class I devices are able to obtain a GUDID account at this time. However, this does not preclude that companies can already obtain their DI number through the Issuing Agency and start placing the UDI on their packages; they just would not be able to enter the information in the FDA GUDID database yet.
  5. Do we need to change the date format on our labeling? The FDA has specified in the regulations that the date format of YYYY-MM-DD must be used for all dating on product labeling such as expiration dates or date of manufacture. If an organization is currently using the MM-DD-YYYY or MM-YYYY format for their expiration dating, then this would need to be changed to stay compliant with the regulations.  UDI time schedules historical notes.
  6. There are many types of bar codes that exist; which one am I required to use? The FDA has made it clear that Automatic Identification and Data Capture (AIDC) such as bar codes are “technology neutral,” meaning that whichever method a Labeler/Manufacturer chooses, there is technology that can be used. An organization must determine which bar code or other AIDC technology is most appropriate for their device and their customer needs. As an example, a Class III device with a long UDI number and a small package may need to consider a 2-D Matrix style bar code in order to fit on the label. Or a Class II device with a large label being sold in small doctors’ offices with limited bar code reader capability could choose to use a GS1-128 style linear bar code on the package label.
  7. I have my UDI, is that all or are the other things that I need to do? As with any regulatory compliance, there always seems to be an endless chore of activities that need to be performed. The quality management system must be updated to include all of the requirements associated with UDI number management. This includes when packaging or labeling is changed that the Change Order process must have an assessment or impact evaluation to continue compliance with the regulations. The customer complaint and adverse event procedures must ensure that they are capturing the UDI information. An overall procedure or process should be documented for how the UDI numbers are managed, including steps for obtaining the number, adding new versions or models, and discontinuing versions or models. It is advisable that the UDI process is integrated into the entire quality management system as it can touch on many areas such as labeling, supplier management, Device History Records, customer complaints, and recall activities.  UDI time schedules guidance notes.

This article originally appeared on www.emergogroup.com.


UDI TIME SCHEDULE.


Validation Risk Assessment (Issue 11) $125.00

Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template.

This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.

The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template 



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template. 



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.