SOP on Expiration Dating
(Finished Product)
1.0 Purpose: This SOP describes the requirements for the expiration date(s) on the finished products.
2.0 Scope: This SOP applies to Production Chemist and Quality Control chemist.
3.0 Responsibility: Quality Assurance Manager to ensure that the procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure:
5.1 To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it bears an expiration date determined by appropriate stability testing.
5.2 Expiration dates are related to any storage conditions stated on the labeling, as determined by stability studies.
5.3 If the drug product is to be reconstituted at the time of dispensing, its labeling bear expiration information for both the reconstituted and unreconstituted drug products.
5.4 New drug products for investigational use are exempt from the requirements provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations. Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product.