Expiration dating period computation

Assuming a common slope with different intercepts for different batches, the expiration dating period is computed for each individual batch. The minimum of the expiration dating periods of the individual batches is the expiration dating period of the drug product. 

In summary, the null hypotheses for equality of slopes and intercepts are not rejected at the 0.25 significance level and, consequently, all batches are considered from the same population. Therefore, the expiration dating period can be computed by using model (45). 

Rules for Determining Shelf Life Once the analysis-of-covariance model has been identified, a set of rules for computing the shelf life must be implemented. This section describes the rules to follow to determine the expiration dating period for each of the nine representative models described in the previous section [8,11] ... 

CO The expiration dating period is computed separately for each batch and... 

Assuming a common slope and a common intercept for all batches, a single shelf life is computed as the expiration dating period of that package. 

If the production batch contains reprocessed material, the expiration dating period should be computed from the date of manufacture of the oldest reprocessed material used. 

You will also need a means of determining when the retention time has expired so that if necessary you can dispose of the records. The retention time doesn t mean that you must dispose of the records when the time expires - only that you must retain the records for at least that stated period. Records will need to be dated, the files that contain the records dated, and, if stored in an archive, the shelves or drawers dated. It is for this reason that all documents should carry a date of origin and this requirement needs to be specified in the procedures that describe the records. If you can rely on the selection process, a simple method is to store the records in bins or on computer disks that carry the date of disposal. 

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