Expiry Dates

Monitor stock, e.g. temperature, pressure, reaction, inhibitor content, degradation of substance, deterioration of packaging or containers/corrosion, leakages, condition of label, expiry date, undesirable by-products (e.g. peroxides in ethers) Spillage control bund, spray, blanket, containment. Drain to collection pit Decontamination and first-aid provisions, e.g. neutralize/destroy, fire-fighting Contain/vent pressure generated to a safe area... 

Limited life items should be identified so as to indicate their useful shelf life. The expiry date should be visible on the container and provisions should be made for such items to be removed from stock when their indicated life has expired. 

Information on (usage within expiry date, storage, signs of deterioration, qualitative composition, pharmaceutical form and content, name and address of marketing authorisation holder and manufacturer)... 

Method of adminisfration Warning to keep out of reach of children Special warnings, if necessary Expiry date... 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

Epinephrine is an inherently unstable chemical in aqueous solution, even at a low pH and in the presence of an antioxidant such as sodium metabisulfite, up to 1 mg/ ml. With the passage of time, the epinephrine dose gradually decreases due to degradation into inactive compounds. If the expiry date has passed, the epinephrine dose correlates inversely with the number of months or years past that date, and will likely be lower than the dose stated on the label even if the solution appears clear and colorless. Nevertheless, if this is the only source of epinephrine available for injection, it should be used in preference to not administering epinephrine at all [32]. 

By contrast, medicines used in the home are not orrly less often eontaminated but also contain lower levels of contaminants and fewer pathogenie orgarrisms. Generally, there are fewer opportunities for contamination here since smaller quantities are used by individual patients. Medicines in the home may, however, be hoarded and used for extended periods of time. Additionally, storage conditions may be imsuitable and expiry dates ignored and thus problems other than those of microbial contamination may be seen in the home. 

Important steps during RM production are the control of properties that determine the quality of the final product and its long-term stability (see the overview of techniques in Table 2.4). As some of the methods discussed below, for example determination of homogeneity, stability and shelf life (expiry date) are also mentioned in other Chapters and in the interest of brevity the reader is referred to them for further details. 

This example presents four analytical situations (a) good control, (b) sudden shift in accuracy - perhaps the calibration material has become contaminated, (c) a gradual shift in accuracy-perhaps a reagent has exceeded its expiry date, (d) very poor precision - perhaps an autosampler is working erratically. 

Implementation of this procedure precludes the necessity of giving expiry dates for these substances. However, no studies are undertaken to test the stability of the substance in opened vials or ampoules nor the substances in solution. Users of reference substances should not store solutions of chemical reference substances or opened vials. 

An accompanying explanatory leaflet may also be provided, if necessary, to describe the preparation of the substance for use. In some uses, a chromatogram may also be provided. As mentioned before, no expiry date is indicated because the products and substances comply with the requirements of the corresponding monograph and are monitored regularly. 

Protocols for these batches and a commitment to continue them along with a tentative expiry date should also be included. Approval of these protocols will allow extension of the expiry date without a special supplement as long as the data remain within specifications. These data will ultimately be reported to FDA as part of periodic reports following NDA approval. Protocols intended for use on commercial batches should also be submitted. 

Unopened bottles of this, all originating from the same batch and well within the manufacturer s expiry date, exploded while warming to room temperature. This was attributed to water contamination leading to hydrolysis and carbon dioxide formation, without supporting evidence—a number of other contaminants, both nucleophiles and acids, might catalyse carbon dioxide formation (Editor). 

All antibodies age and therefore have a specific shelf life. Aging may be different for different antibodies, and real aging may be quite different from the expiry dates printed on containers of antibodies. Mixtures of antibodies as are found in secondary antibody cocktails may show distinct aging differences. In other words, over time, one of the species in a secondary cocktail may age at a more rapid rate than the other(s). This would result in a significant decrease in sensitivity for that particular species of primary antibody. A user performing IHC stain runs with multiple tissues, and using primary antibodies from more than one species, must utilize primary controls for each species of primary antibody to detect a change in one of the components of the secondary antibody cocktail. 

Storage areas, such as refrigerators, freezers and cupboards, should be regularly checked to avoid build-up of unnecessary items. Reagents and standards, which have passed their expiry date, and samples which need no longer be retained, should be appropriately disposed of. The laboratory should ideally keep records of what it has disposed of and when (and possibly also how). 

Storage and preparation of polyclonal and monoclonal antibodies are very important for successful immunostaining. When a new antibody arrives in a laboratory, special attention should be paid to its storage instructions and optimal temperature. Detailed records of arrival and expiry dates, and whether it needs to be aliquoted to maintain efficacy by avoiding ffeeze-thaw effects, should be kept. Attention to these details will preserve the efficacy of the antibody and its shelf hfe, prevent damaging freeze-thaw cycles, and will make optimization of the immunohistochemical procedures easier, ft is often necessary to aliquot antibodies, especially when storage below 4°C is required. 

Storing and titrating antibodies correctly are often easy solutions when no staining is observed. Some antibodies are extremely sensitive to repeat freeze-thaw cycles and others have a limited shelf life, as evidenced by a short expiry dates, ft is important to check the compatibility of the primary and secondary antibodies before starting IHC, as using the wrong secondary IgG is a common but easily corrected problem. As mentioned, antigen retrieval can be a problem when tissue has been overfixed, so special attention should be paid to fixation time and, once optimized, should be held constant for all subsequent runs. 

One thing that has been added to the amendment is clear expiry dates for the exemption of about half of those materials and components listed in Annex II. A lot of those expiration DA dates apply to the exempt status for lead compounds in vehicles. 

As Daktacort cream contains hydrocortisone, a mild steroid, its use is rarely associated with side-effects unlike the potent and very potent steroids. The product is generally applied once or twice daily for 1 week. It should be discarded once the expiry date has elapsed. Daktacort is only available as cream or ointment. 

Extemporaneous preparations, such as creams that are prepared in the pharmacy, have an expiry date of 4 weeks. The creams can be stored at room temperature. 

Records for date of receipt, expiry date, quantities received and used in studies etc. 

The United Kingdom Medicines Act 1968 regulations require that all medicinal products are properly labelled to certain minimum standards, but requirements vary from country to country. Clinical trial materials, however, cannot be labelled normally because if the trial is blind, nothing should reveal to the patient or physician the nature of the contents. The basic information on the label should provide the patient s name, study phase, study number, directions for use, any special warning or storage requirements, expiry date and the investigator s name and address, along with an indication that the... 

Dates, dosage and batch number(s) with expiry dates of study drug... 

Frequently, in early trials of a new study drug, the expiry date is extended as more stability data become available. Any additional labelling by the sponsor or by the investigator should be documented fully and, where possible, a second person should (2C the process. The labelling should always meet the GMP regulations applicable in the location. 

A reference to the expiry date indicated on the label, with... 

Medicines, except for goods solely for export or for use in clinical trials. The requirements include names and quantities of active ingredients, dosage form, batch number, expiry date, the registration or listing number (AUSTR or AUSTL number, respectively), identification of inactive ingredients, what labelling is adequate for special packs and small containers, and letter size and additional requirements in particular circumstances. 

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