Raw material expiration dating 21cfr

The buying public does not have access to freshness discussion with an exp date.An exp date is best suited for drugs and products that are highly processed/industrialized, or for products that have high level sugars and proteins that are prone to high level of bacterial growth over time.PRO: An expiration date does not identify when the product is packaged so the buying public really does not understand how fresh a product is or is not if a exp date is provided rather than a manufacturing date.Our oils are extracted without heat or introduced chemicals but rather enzymatic and bacterial culturing/digestion/fermentation.Assume the API is properly stored in an appropriate environment, but no further testings after entry. I understand that we should keep the batch of drug product for stability monitoring. Why did you extend the shelf life of the raw material?Any supporting guidelines or argument that we can follow. For raw material, you mean we should sample enough amounts for testing througout the extended shelf life? Was your retesting appropriate (did you perform Assay, Related Substances, Moisture...)?Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.

means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

My question is that, For example, an API raw material which is going to be expired in October 2016, are taken to be used for manufacturing a product (e.g.

tablet) which its shelf life is, perhaps 2-3 years. It feels that we have extended the API lifespan 2 years or more.

means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

means any person who designs, manufactures, fabricates, assembles, or processes a finished device.


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