Expiration dates

The primary thmst of GMP is that it is not enough merely to make chemicals to meet USP or other apphcable specifications. The chemicals must be made under clean and sanitary conditions, procedures and processes must be vahdated and documented, and processing and packaging must be carried out under conditions that preclude mixup and mislabeling. Records must be kept of complaints, and the manufacturer must know enough about the storage properties of the products to specify storage conditions and, if necessary, expiration dates on the label. 

Stabihty studies ate developed to assure a desirable shelf-life period. These also estabhsh limits of acceptabiUty for impurities and degradation compounds, when present, and determine acceptable storage conditions for raw materials and the manufactured products. Stabihty studies are thus important to the deterrnination of expiration dates for dmg products. 

Term time frame with expiration date... 

Within each subcategoiy are any specially designated tempo-raiy procedures required for equipment operating in one of the four operating phases. These procedures are typically short lived due to a terminating condition or expiration date. They describe special tests or temporaiy changes in operating steps. These tempo-raiy procedures can be archived when they are not active. 

Is a list of water discharge permitting agencies, permit numbers and expiration dates available ... 

One person in a unit retrieved a two-year-old shutdown procedure from his locker and tried to use it. The old procedure was significantly different from the updated procedure. If the old procedure were followed exactly, there would be more risk. If the two procedures were intermingled, there would be high temperature and catastrophic corrosion. The unit management team tore up the bootleg procedure and added the updated shutdown procedure to the controlled document system used for ISO 9002 (ISO 9000, 1994). In this document system, only the current procedure is available. Alternate systems may use an expiration date or require periodic reconfirmation. 

The patent expiration date (in the U.S. usuaily 17 years after the patent issuance date cited) offers the opportunity to duplicate and practice the patented process without legal conflict after expiration. 

The steam-power systems in Trevithick s youth were massive hut lightly loaded low-pressure engines. This technology was controlled by Boulton Watt, whose business acumen had extended patents far beyond their normal expiration dates. The royalties typically took one-third of the savings in fuel over the Newcomen atmospheric engine. Another necessary evil was the expense of fuel, as coal was not locally mined. Cornish engineers worked incessantly to design and invent their way past these limitations. 

The expiration date (the date after which any unused solution is discarded)... 

It is important to use the tetracyclines cautiously in patients witii renal function impairment, hi addition, doses greater that 2 g d can be extremely damaging to die liver. The nurse should carefully check die expiration dates of die tetracyclines before administration because degradation of the tetracyclines can occur after degradation, the agents are highly toxic to the kidneys. 

Check the expiration date on die container of sublingual tablets. If the expiration date has passed, do not use die tablets. Instead, purchase a new supply. Unused tablets should be discarded 6 months after die original bottle is opened. 

The statistical interpretations are there is a 5% chance that the extrapolation is below 90% at f = 26 and there is a 5% chance that a further measurement at / = 26 months will yield a result below y 89% of nominal. Every batch in the stability program is subjected to this procedure the batch that yields the shortest shelf-life sets the expiration date. Possible solutions are as follows ... 

If the authorities request an overage-free product, for an SL of 90% an expiration date of 18 months results (this would be a pain for the Logistics and Marketing Departments because... 

Note that this case study was calculated on the basis of an old report in which all assay values were rounded to the 0.1% position if the raw data had still been accessible, the conclusions would probably have remained the same, but some specific numbers could have changed. This situation is very common if data trends over several years are investigated. It is not unusual that raw data from routine production QC release tests are destroyed a year or two after the expiration date of the product because local laws do not require longer retention. 

ATCC issues Certificates of Analysis with cultures. Although ATCC Certificate of Analysis do not meet the specific requirements of ISO Guide 31, they do show that the biological RM culture has been authenticated and/or specific characteristics have been verified. Each ATCC Certificate of Analysis is lot-specific and includes expiration dates, the specific seeds used for propagation, and selected biochemical and morphological characteristics that are indicative of the culture. ATCC also aims to provide a Product Sheet for each microbial culture, with instructions for propagation, special features of the organism, and any imusual observations or properties. 

Pharmacopoeial standards and substances are established and distributed by pharmacopoeial authorities following the general principles of this Guide. It should be noted, however, that a different approach is used by the pharmacopoeial authorities to give the user the information provided by certificates of analysis and expiration dates. Also, the uncertainty of their assigned values is not stated since it is negligible in relation to the defined limits of the method-specific assays of the pharmacopoeias for which they are used. ... 

For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under 211.137, the reserve sample shall be retained for 3 years after distribution of the last lot of the drug product containing the active ingredient. 

For a drug product other than those described in paragraphs (b) (2) and (3) of this section, the reserve sample shall be retained for 1 year after the expiration date of the drug product. 

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