Finished Product Expiration Dating

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8.1 It is the responsibility ofR&D to assign an expiration dates based on standard overages

 and seek expert adivice when no standard overage is assigned. . 
 lt is the regponsibility of R&D in conjunction with QS Laboratory Management to
 formulate the product to meet shelf life expectations. 
 
 It is the respomsitility of DC to track and log batches that require stattiliby testing.
 
 It is the regpunsitility of the @E Laboratory Management to execute a stability plan for
 the batches tracked for stalnility by DC. 
 
 4.00 Definitions 
 
 411 Controlled’ Room Temperature - A temperature maintained thenmostatiedlly that
 
 brackets the usual and customary working emvironment of20"C to 258C (686F to 77°F)
 that results in a mean kinetic temperature calculated to be not more than 258C and that
 allows for minor fluctuations between 1S'C ant 30°C (S9F anti 86'F) that are
 experienced in phanmacisss, hospitals, and warehouses. 
 422 
 QE = Quatity Control 
 433 
 DC = Document Control 
 M44 
 CofA = Certificate of Analysis 
 As5 SOP. Standard Operating, Procedure 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 ” Page 2 of3 
 Finished Product Expiration Dating C-706 4 
 
 Ac6 R&D = Research and Development 
 
 500 
 Referemces 
 511 
 C-104, SOP, Master Batch Record and Issuance ofBiitctn Productiom Record
 22 D-501, SOP, Staltility Progam for Finished Products 
 
 £33 
 D-902, SOP, Establishment of Specifications 
 514 §E-702, SOP, Finished Product Sampling Procedure 
 
 600 
 Procedure 
 At1 
 During the quote process R&D seeds an expiration date baset on the stability
 characteristics of the formulatiom and the customer's specifications.
 422 
 The stdbllity charadiznistiics of a formulation may be based om ome or more Of the
 following: 
 4.7211 Previous stability data for similar formulations. 
 
 4.722 Accelerated stability data for the current formulation. 
 
 4233 Scienifiic literature which examines the stdbllity Of specific ingredients or
 indiviciwal analytes present in the formulation. 
 
 33 
 The excess amoumt of amy component in a formulation relative to the label claim for
 that component (the overage) is determimed based on: 
 4.3311 Known stability characteristics of the component. For example, asoorbic acid is
 known to be inherently unstable, therefore am overage must be added to ensure
 
 that the product will meet spauification thoughout its life cycle.
 4222 The finished product gpectiicdtion far the component. For example, if the
 
 gpanification is NLT 100% of label claim, an overage should be added to ensure
 that the component passes specification without regard to stalhility.
 444 If prodwot stability is umknowm and the customer has no spaciiic requirements, the
 
 default is two years. 
 A55 Once the quote is accepted amd the customer places an order, a prodwot profile is
 
 generated in accordamcee with D-902 Establishment of Specificationss which contains the
 sinellf life and testing requirements. 
 466 
 Stability batches are identified by DC as per SOP C-104 Master Batch Reoord! and
 Issuance of Batch Productiom Record. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Finished Product Expiration Dating €-706 4 Page 3 of3 
 
 Ar / Stability samples are delivered to the QE Laboratory as outlined in SOP E-702 Finished
 Product Sampling Proceduite.. 
 
 438 
 QC Laboratory Management reviews the conesponding finished prodwoat profile and
 generates a stability protocol based om the guidelines of D-501 Stability Program for
 Finished Products with the testing and spauifications outlined in the respective product
 profil. 
 A99 
 QE Laboratory Management prepares a statnility trend card for trending the stalbility test
 results at eadh time internal according to D-501 Stability Program for Finished
 Products. 
 4140 Once Stability testing is complete, a second verificatiom check is recorded in the product
 
 stalility protocol by QE. 
 4111 DC stores and maintaims the completed product stability protocols with accompanying
 
 trend cards for all required products. 
 A112 An expiration date is considered verified after stability testing for the first thee lots has
 
 been completed successfully as outlined in the corresponding stalbility protocol.
 7.00 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/20/10 | New E : 02/28113 Changed the SOP format. SOP updated. 1B44A R. Howard Biennial review. Updated SOP format. Rewision 1 obsolete. New 2 03/09AI5 procedume written for raw material and finished product (Dietary 15-0163 B. Johns Supplemenis)). New Title. Sourced D-501 directly for requirenmemits to establish expiration OA 3 vinings dating on finished products. Changed title to include Cosmetics. ial fas Satine Update References, Purpose, and Scope. Remove raw material | - | - |
| 4 | 03/04/20 | expiration dating since this is covered in D-901. Combime D-706 CCZMALBM S. Sassman and D-706.0 since the process is similar for dietary and drug. | - | - |

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