Specification-check/shelf-life

Specification-Check/Shelf Life [ICH Q1A] — Combination of physical, chemical, biological, and microbiological test requirements if a drug substance must meet up to its retest date or that a drug product must meet throughout its shelf life. 

It is the responsibility of the individual laboratory to rigorously evaluate each new lot of IA kits for sensitivity, precision, accuracy, and specificity to assure assay reliability. Lot-to-lot variation in kit reagents has been verified by several authors with respect to digoxin RIA kits (187-189). It is necessary to assure the availability of a large number of kits with the same antibody lot from the manufacturer before the evaluation. Once the evaluation is found to be satisfactory, reservation of these kits should be made to cover the entire study. If a tracer lot has to be changed during a study (such as 125I label, which has a short shelf life), QC performance should be checked to ensure that assay performance... 

For products described in a pharmacopoeia, the official specifications can and should be used for the product file, with referral to the official source. The same applies to preparations from standard formulatimis, in which quality requirements are included. For in-house formulations, the quality requirements have to be set by an appropriately competent person internally. Useful information can be found in the formulatimi or validatimi studies. The results of stability studies may be useful when setting the quality requirements for the product, because the premise is that a preparation should comply to the quality requirements throughout the whole shelf life. An overview of the applicable quality requirements, including supporting information, has to be included in the product file. In addition it should be specified how the packaging and labelling are checked, and how and with what analytical method the product quality is controlled. Additionally the validation of the analytical methods is included in this section of the product file. 

A further consideration is the shelf-life of constituents. This is typically three to six months for resins and 12 months for fibres and fabrics. If this is exceeded then at least one appropriate property needs to be measured to check that the material is still within specification. It is best to check this procedure for extending material life with the supplier. 

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