Storage statement

A storage statement for the finished API should be prepared in compliance with the national and regional requirements. The established retest period, which is supported by the stability data, should be displayed on the certificate of analysis (COA) and as appropriate on the container label also. 

A storage statement should be established for the labeling in accordance with relevant national and regional requirements. The statement should be based on the stability evaluation of the drug substance. Where applicable, specific instructions should be provided, in particular for... 

Supporting Data — Data, other than those from formal stability studies, that support the analytical procedures, the proposed retest period or shelf life, and the label storage statements. Such data include (1) stability data on early synthetic route batches of drug substance, small-scale batches of materials, investigational formulations not proposed for marketing, related formulations, and product presented in containers and closures other than those proposed for marketing (2) information regarding test results on containers and (3) other scientific rationales. 

Clearly specified storage statements and expiration dating periods, especially when these are different for different product strengths and/or container-closures... 

A stability report is written to document expiration dates and a storage statement for the registration batches for the formal stability studies. It is also used to document the expiration date for formulations that are being used in the clinic. In this case, the expiration date is generally a date when the product should be discontinued or that additional data are required to extend the expiration date. A more detailed discussion of the information included in the stability report is given in Section lI.E. 

The objective for a stability program is to determine the expiration date of the product in its respective package(s). It is also to determine the proposed storage statement recommended for the product for it to continue to meet all the requirements of quality, purity, strength, and safety in the marketplace. The label storage statement must include storage precautions, if appropriate, for the pharmacists and the patients. 

Serious attempts have recently been made to clarify the storage statements used for pharmaceutical products, with a view to eliminating such vague phrases as store in a cool dry place . 

Single label statement (no storage temperature statement) is acceptable if product has the ability to withstand temperatures to 30°C (based on support data). Below 30°C, storage statements are necessary, e.g. ... 

For a drug product demonstrated to be stable at 5° 3°, 2°-5°, or 2°-8°C with or without humidity control and that is intended to be stored at refrigerator temperature, the recommended storage statement for labeling may be one of the following ... 

If changes that are observed when the product is directly exposed under the light conditions described in the QIB guidance are acceptable, no labeling storage statement regarding light is needed. 

If changes that are observed are acceptable only when the product in the market pack is exposed under the conditions described in the Q1B guidance, labeling storage statements regarding fight should be included. 

Examples of typical storage statements are, for singledose and multiple-dose products, respectively, PROTECT FROM LIGHT. Retain in carton until time of use. and PROTECT FROM LIGHT. Retain in carton until contents are used. ... 

The effect of the stability data on the retest period, shelf life, and expiration date and recommendations for the storage statement should also be presented and be consistent with stability guidance docmnents relevant to the appropriate regulatory agency. 

ICH Q1A(R2) and the WHO Expert Committee on Specification for Pharmaceutical Preparation provide similar recommendations for storage statements and labeling. 

The stability data of the drug product should be a direct link to the label storage statement. An expiration date should be displayed on the container label. 

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