Storage minimum time period

Stability Study Type Stability Storage Conditions Minimum Time Period Covered by Data at Submission (months) ... 

Study Storage condition Minimum time period covered by data at submission... 

Table 7 Retest Study, Storage Condition, and Minimum Time Period...

Table 8.7 Retest study, storage condition, and minimum time period.

It is important to keep the amount of potentially hazardous waste in the laboratory to a minimum at all times. Periodically, contents of the laboratory waste containers will be transferred to appropriate containers for final disposal. These must be stored in a safe location, often outdoors, while awaiting pick-up by a disposal service. There will be local restrictions for such storage. A locked storage area may be needed, for example, to prevent unauthorized access to hazardous materials. The fire department niiay set strict limits as to how much flammable material may be present. All containers must be marked with contents, and the storage area will no doubt require warning signs. 

In any case, it has to be stressed that it should be possible for all material for which the GLP Principles require retention, to be retrieved and investigated during the whole period of time which the country, where the test facility is located, stipulates as the minimum time of storage. Every change in the conditions of archiving has therefore to be fully documented. Only in this way will it be possible to trace the fate of documents, records, samples and specimens even after their placement into storage. 

The stability of the protein in the biological matrix at intended storage temperatures (e.g., —20 C or —80°C) is assessed by determining freeze-thaw stabihty at a minimum of three cycles, short-term room temperature stability, and long-term storage stability for the time period of typical storage times (e.g. six months). 

Assessment of the hydration resistance of basic bricks and shapes can take place in pressurized systems in an autoclave or pressure cooker or without pressure by storage in a humidity chamber. Generally, bricks with a minimum of three original surfaces are required. Specimens are examined after a set time period and results calculated or repeat tests take place until a specific total test time is reached or until the refractory disintegrates (3,4). 

Shelf life — A period of time in which a -> battery can be stored under specified conditions before it fails to deliver minimum specified performance of energy and - power. The shelf fife of batteries, primary and secondary, is dependent on the type of battery, the storage temperature and humidity, and on the state of charge. The main sources that limit batteries shelf fife is self - discharging, - corrosion, and dehydration. 

A regular review of data stored in the archive is essential not only as indicated earlier to detect any degradation of the storage media, but also to determine if the archive technology or record is becoming redimdant. Periodic assessments will be needed to decide whether or not to maintain the archive electronic records. It may be decided only to maintain critical records such as those involved with batch records, batch sentencing and recall, over longer periods of time. Once the retention period is over, a follow-on decision will need to be taken as to whether to retain the electronic records for a further period or to destroy them. The minimum retention times for some example electronic records is indicated in Chapter 12. 

A minimum durability date should be provided and for highly perishable foodstuffs a use by date should be given. This latter requirement is a hindrance to the use of a time temperature indicator (TTI). A use by date should also cover foreseeable incorrect storage conditions, e.g., during transport. Therefore use by dates are set on a very safe (short) period. By use of appropriate TTIs the total safe consumption period could be used for the benefit of both the consumer and the manufacturer or retailer. It is assumed that further effort by TTI manufacturers may result in a legal recognition of TTI as a replacement for use by dates. 

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