Data evaluation drug product stability

Specifications and Test Methods Storage Conditions Testing Frequency Stability Commitments Data Evaluation DRUG PRODUCT... 

Product stability Inspection of the establishment to determine compliance with cGMP requirements and to conduct an audit of the data furnished to CDER in the application is a Field responsibility. This requirement applies to both the relevant preapproval batches, as discussed above, and the proposed commercial batches. CDER application review chemists are responsible for review of the proposed drug product stability protocol, specifications, and evaluation of the data submitted in support of the expira-... 

Data on stability of the drug products should be presented for all testing intervals and evaluated with physical, chemical, and microbiological, microbial preservative effectiveness, antioxidant effectiveness, and functionality tests as appropriate to the... 

The stability data evaluation for drug substance or drug product intended for storage at room temperature should include evaluation of any significant change at... 

Stability studies during the IND phase provide not only assurance of the quality of clinical trial material but also the basis for the drug product development program. Stability data are used to evaluate different formulations, methods of manufacture, and container-closure systems, as well as to determine storage requirements, expiration dating periods, and specifications. 

Stability Protocol A postapproval stability protocol should be submitted documenting future plans. It should include information on time points and storage conditions to be evaluated, and indicate whether extensions of expiration dating are intended based on sponsor evaluation of data obtained following the protocol. These data will still have to be submitted, as well as the details of the extensions of expiration dating being implemented, in the annual reports filed with FDA. Also indicate how many batches of drug product will be placed on stability in a year. 

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