Re-test date

If a significant failure occurs within the first 3 months at 40°C/75% RH, the proposed re-test date should be based on the real-time long-term data. In addition, if a failure does occur within the first 3 months, data will have to be presented to allow use of the drug substance if any excursions occur outside of the proposed labeling. 

For a 12-month re-test date, the drug substance long-term samples should be tested every 3 months for the 1st year, every 6 months for the 2nd year and then annually. 

If the submission does not include long-term storage data on the primary batches through the proposed re-test date, the studies should be continued through the postapproval phase to establish the re-test period. 

Data on the drug substance stored in the proposed packaging under storage conditions that support the proposed re-test date. 

The combination of physical, chemical, biological and microbiological test requirements that a drug substance must meet up to its re-test date or a drug product must meet throughout its shelf life. 

Stocks of Starting Materials should be inspected at intervals to ensure that the containers are properly dosed and labelled, and in good condition. They should be re-sampled and submitted for re-test at the intervals given in the starting material specification. Such resampling should be initiated by the application of re-test date labels and/or by similarly effective documentary systems. 

To date, the Part II Programme has focused upon four major projects (1) The development and implementation of a set of Principles of Good Laboratory Practice (GLP s) (2) Resolution of issues concerning Confidentiality of Data (3) Development of a Glossary of Key Terms and (4) Development of guidelines and other procedures for the exchange of information (e.g., re test data, the export of hazardous chemicals, and the labelling of hazardous chemicals). 

If you score less than 80%, then work through the text and re-test yourself at the end using this same test. If you still get a low score then re-work the unit at a later date. 

Name Code / Batch Lot No / Purity Concentration / No Certificate of Analysis / Expiry Re-analysis Date / Date Received / Amount Received / Gross Weight / Storage Conditions / Date Container Opened / Test Item Logistics OK (Initials)... 

Reserve samples of the released excipient should be retained for one year after the expiration or re-evaluation date, or for one year after distribution is complete. Sample size should be twice the amount required to perform specification testing. 

If testing indicates a short shelf life under anticipated storage conditions, the excipient should either be labeled with an expiration date or be re-evaluated at appropriate intervals to determine its continued suitability for use. The expiration or re-evaluation date must be derived from appropriate stability testing or from historical data, if the excipient has been in the market for a long time. With few exceptions, expiration dates are not presently considered to be a general requirement for all excipients. Thus, the absence of an expiration date is not objectionable. 

Documentation. Tests conducted under this paragraph must be documented. The document must contain the date, test results and the name of the tester. The document must be retained until the derrick is re-tested or dismantled, whichever occurs first. All such documents must be available, during the applicable document retention period, to all persons who conduct inspections in accordance with 1926.1412. 

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