Raw material expiration dating 21cfr


Rgds moskito For clarification purposes, best by dates of raw material used must fall within the best by date of the finished product, correct? I am blending a certain spice, best by date of ground ginger is 4.20.19, can I use that ground ginger as a component of my spice blend that will have an expiry date or best by date of 4.20.21? Dried spices lose their flavor and aroma over time, but they do not support bacterial or fungal growth unless they are improperly stored or get an insect infestation.

If not shelf life extension of the raw material must be requested regardless if the customer is the one who dictates the shelf life of the product, it must be supported by shelf life study. I am blending a certain spice, best by date of ground ginger is 4.20.19, can I use that ground ginger as a component of my spice blend that will have an expiry date or best by date of 4.20.21? The rule of thumb in spice blends is that the ingredient with the shortest shelf life or the soonest expiry sets the shelf life for the product.

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This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].26, 1990; 61 FR 24232, May 14, 1996; 62 FR 39901, July 24, 1997; 64 FR 56449, Oct.

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Hi, Does anybody know how does the raw material expire date reflects on your finished product expire date?

24, 2005; 73 FR 39610, July 10, 2008; 77 FR 26174, May 3, 2012] This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.Why Should You Attend: During the last several years, FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for lack of adequate systems for evaluating the suppliers of raw materials and the components, to ensure that these materials are acceptable for use.It is the FDA requirement that all raw materials that are received and used in producing APIs and drug products should be qualified using a system to ensure that raw materials are of acceptable identity, quality and purity before use.A biologics license application or supplement for which FDA issued a complete response letter, but which was withdrawn before approval and later submitted again, is not a resubmission.


20, 1973, as amended at 40 FR 31313, July 25, 1975; 55 FR 11014, Mar.For that reason in many cases we reduce the shelf life of raw materials because at the end the final product needs a shelf life of additional e.g. We now the blanched almonds used in baking will result in a rather short shelf life of the final biscuit due to double heat treatment causing with special ingredients rancidity.



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