The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR). D is going to invoke the not rocket science clause as the requirement for traceability is rooted in common sense. The requirement begins with clear pointers to the device: (a) being deployed as a surgical implant (placed into the body); (b) used to support or sustain life when properly (safety and efficacy) used (hopefully employed in a procedure by a trained and licensed physician); and (c) failure of the device to perform in accordance with the instructions for use (product labeling), which results in injury. In short, traceability needs to be captured in the DHR.
Retest due date shall not be more than expiry date of raw material.
If expiry date is less then assign the retest date of 1 year or half the period as stated in annexure I & II whichever is less for that particular material.
(August 2017) Carmine is one of the color additives that must always be listed by common or usual name within the ingredient statement.
The fact that your carmine is derived from fish, one of the big 8 allergens, also requires that you alert consumers about a potential allergic reaction by specifying the exact species of fish.
There are two options for how to declare the fish allergen and species on the package.