Expiry/expiration date

EXPIRY/EXPIRATION DATE The date (usually placed on the containers/labels of an API) designating the time during which the API is expected to remain within established shelf-life specifications if stored under defined conditions and after which it should not be used. 

Extrapolation of data from one material to another must always be based on sound scientific principles and all available data. Even so, extrapolation always bears risk. To demonstrate that every batch of clinical trial material was within applicable specifications for the duration of its use in clinical studies, some firms test every batch of clinical trial material at expiry. This is especially valuable when an expiration-dating period was not based on real-time data for the precise clinical trial material in the precise container-closure used in the clinical trials. 

Assess the stability characteristics of drag products that should be established and followed to determine appropriate storage conditions and expiration dates. This should include the periodic retesting of finished products during their storage. Similar written procedures should also exist to outline how the expiry conditions and dates for medical devices should be monitored. 

An API expiry or retest date should be based on an evaluation of data derived from stability studies. Common practice is to use a retest date, not an expiration date. 

G. All batch serial records should be kept for a minimum period of five years to meet further requirements. Separately, samples taken from each batch series in sufficient quantities should be kept under suitable storage conditions until the expiration date of use. Samples of drugs which have no expiry date are to be kept for five years starting from the date of manufacture. 

Limited life items should be identified so as to indicate their useful shelf life. The expiry date should be visible on the container and provisions should be made for such items to be removed from stock when their indicated life has expired. 

One thing that has been added to the amendment is clear expiry dates for the exemption of about half of those materials and components listed in Annex II. A lot of those expiration DA dates apply to the exempt status for lead compounds in vehicles. 

A system should be in place to ensure that pharmaceutical products due to expire first are sold and/or distributed first (FEFO). Where no expiry dates exist for the products, the FIFO principle should be applied. Exceptions may be permitted as appropriate, provided that adequate controls are in place to prevent the distribution of expired products. 

As an example, in March 2003 bond options expiring in April, May, June, and September were all available. The first three were exercisable into the June futures contracts, while the last one was exercisable into the September futures contract. Although all four expiry dates were theoretically available, only those options exercisable into the front futures contract (the next one to mature) were liquid. On 7 March 2003, the front contract was the June 2003 future, and over 99% of all futures trades and 99.9% of bond options trades involved this contract. Exhibit 17.7 provides a breakdown of these figures, showing the total number of contracts traded on that day. 

The longer the option s time to expiry, the more valuable is the option. In all cases, the options expiring in May are more valuable than those expiring in April with the same strike price and, similarly, June options are more valuable still. This is sensible when one thinks of the risk experienced by the option seller. The further the expiry date, the greater the uncertainty as to where the price of the underlying bond will be in the future, and therefore the more valuable the right to execute a trade in the future at a price fixed at the outset. 

To provide an idea of which of the EURIBOR contracts are liquid. Exhibit 17.12 shows the trading volumes on 7 March 2003 for the 10 expiry months available on that date. As with the bond options discussed earlier, the March 2003 options are exercisable into the March 2003 futures contract, the April through June 2003 options are exercisable into the June 2003 future, and the remaining options are exercisable into the future expiring in the same month. 

You can see why a cap is actually a combination of single-period options by thinking about what happens every six months. In our example, the expiry dates of the nine caplets are set to coincide with the company s EURIBOR setting dates. Six months after the loan commences, the rate for the second interest period will be set by reference to the EURIBOR fixing that day. On the same date, the first caplet expires. If EURIBOR is above the strike rate of 3%, the company will exercise the caplet and receive compensation if EURIBOR is lower, the company will simply let the caplet expire worthless. The same process will apply six months later, and so on. 

Good stock control relies on the principal of first to expire, first out which means that, with manual storage of articles, the one with the shortest expiry date have to be placed so that they will be picked first. Robotic systems rely on the computer program to select the product with the shortest expiry date. 

The stock of pharmaceutical products must be regularly checked for products nearing their expiry date, accounting for a reasonable usage period for the user e.g. patient, stock hold on wards etc. Expired products must be removed from the shelves immediately (see also GDP [4] Sect. 5.5). 

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