Shelf Life Of Medical Products

126 127 the authorization of importation of medical products by national regulatory authorities nra 128 sometimes further delay access to medical products.

Shelf life of medical products.

The shelf life of a product may vary between different countries regions depending on regulatory requirements. The purpose of this document is to. Stability as the extent to which a product retains within specified limits and throughout its period of storage and use the same properties and characteristics that it possessed at the time of manufacture it is important to note that a medical device s. The federal shelf life extension program slep extends the expiration dates on qualifying drugs and other materiel in federal stockpiles.

The product shelf life for semiconductor products is based on a number of factors including the type of materials used in the device manufacturing conditions moisture sensitivity levels msl the use of moisture barrier bags mbbs in product packaging the amount of desiccant used and the customer storage conditions. Food and drug administration fda. Preservatives and antioxidants may be incorporated into some food and drug products to extend their shelf life. Working document qas 19 788 rev 1 page 2 41 schedule for draft working document qas 19 788.

The dod shelf life program defines shelf life as the total period of time beginning with the date of manufacture date. To summarize the shelf life of ipa is indefinite not to be confused with infinite meaning the life span varies by storage conditions and thus manufacturers generally provide a generalized expiration date. We recommend following manufacturer recommendation storing chemicals under best case conditions and replacing retesting ipa solutions. Slep is administered by the u s.

A harmonized approach may. Shelf life defined the united states pharmacopoeia usp defines shelf life i e. Medical device shelf life aging studies medical device manufacturers wishing to gather data on the shelf life of their products may subject their devices to long term stability studies or accelerated aging studies. Federal shelf life extension program fact sheet overview.

There are many different endpoints that can be used to assess the shelf life of a medical device including sterility or package integrity so. The shelf life for a combination product is determined from drug stability device aging and sterile barrier aging with the shortest estimate determining the overall shelf life. 124 medical products throughout the supply chain ensuring the availability of quality products 125 within the remaining shelf life in reaching the end user. Department of defense dod in cooperation with the u s.

1 the program is an acknowledgement that the actual shelf life of drugs.