Drug stability expiration dating

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Prescription drug products stability and expiration dates* UTMB/NASA-JSC Aerospace Medicine Grand Rounds Houston, TX October 27, 2009 Mansoor A. It is expected that a well designed formulation and packaging protects the product from degradation A shelf-life generally means a product will retain approved specs in the final packaged container, in stated storage conditions, when tested by validated methods An expiration date must be placed on container label (21 CFR ). Applicant conducts systematic stability testing (21 CFR ) according to a prescribed protocol Select samples from representative batches Store samples at defined storage conditions* Accelerated (40ºC/75% relative humidity or RH) Long-term (25ºC/60% RH) Intermediate (30ºC/65% RH), if needed *(Other stress conditions, e.g., light, acid, base, oxidant, for one-time testing) Pull samples at predetermined intervals 8 How is Shelf Life Established?

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Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach.

22 Repackaged Product Background The draft guidance, CPG 7132.b11, specifies conditions where it may be possible to assign up to 12 months expiration dating to non-sterile solid and liquid oral dosage form drug products repackaged into unit dose containers for Class A, without conducting new stability studies.

According to USP, a unit dose container is designated Class A if not more than 1 of 10 containers exceed 0.5 mg/day in moisture permeation rate, and none exceeds 1 mg/day. More information SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption More information Biopharmaceutics Classification System based on Solubility/Permeability Biowaivers for BCS I Drugs Discussion of BCS III Drugs Models establishing in vivo-in vitro Correlations (IVIVC Levels A-C) 1 Biopharmaceutics More information Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance by Tom Savage, NSF International Since 2008, when patient deaths were first linked to More information GDUFA Regulatory Science Update Robert Lionberger, Ph. Director Office of Research and Standards Office of Generic Drugs Center for Drug Evaluation and Research, FDA GPh A Annual Meeting Feb 9, 2015 Goals More information Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation More information English translation of Attachment 2 of Division-Notification 0229 No.

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(also referred to as the "parent guidance") and defines the stability data package in submissions for "existing" drug substances and associated products.

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