Expiration dating products

Knowing what software is used within a company is one thing. Knowing what the software license encompasses is a different story. It is not uncommon for an organisation who uses software to be unaware of issues such as the number of users allowed (named users or concurrent users), the license expiration date, product warranties, (period of) software support, consultancy (tariffs), delivery of upgrades (like Y2k-compliant versions) and so on. A contract management system should track the software (and likewise hardware) contracts. 

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. 

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. 

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. 

The receipt of the test substance should be documented upon arrival at the test site. The name of the product, manufacturer, active ingredient concentration, expiration date, storage location, storage requirements, lot or batch number, the amount received, the condition at receipt, and whether the material is an emulsifiable concentrate (EC), fiowable, powder or otherwise should be noted in the research notebook. In addition, one should note the purchase date, the shipment date, and the carrier of the product. 

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

A specific statement then is given that requires that a reserve sample be retained for all required tests and that it should be available for at least 2 years after distribution of the last drug lot that utilized the components or 1 year after a stated expiration date of the finished product. 

This section also concerns itself with the ability to review laboratory test procedures and laboratory instruments used. It is stressed that reserve samples of marketed products must be retained in their original containers for at least 2 years after the final distribution of a lot or at least 1 year after the drug s expiration date. In this same light, laboratory data for each batch or lot of drug should be retained for these time periods... 

Oral Administration. Oral administration is the preferred route of administration. There is a general consensus among pediatricians and parents that children younger that 5 years of age have great difficulty with, or are unable to swallow, a solid oral dosage form. Manufacturers, therefore, have developed liquid formulations for many of the commonly used pediatric products. The liquid dosage form, however, is not free of problems. Liquid products are often unstable and have short expiration dates accurate measurement and administration of the prescribed dose is also a problem, especially in infants. 

Recommend products that contain the following on their label scientific name of the botanical, quantity of the herb, name and address of the actual manufacturer, a batch or lot number, date of manufacture, and expiration date. When available, products that are standardized to the active ingredient(s) should be recommended. A common rule of a one-year expiration date on dietary supplements generally applies [5]. 

Under usual circumstances, most manufactured products require a shelf-life of 2 or more years to ensure their stability at the time of patient consumphon. Commercial products must bear an appropriate expiration date. This date identifies the time during which the product may be expected to maintain its potency and remain stable under the designated storage condihons. The expiration date limits the hme during which the product may be dispensed by the pharmacist or used by the patient. 

For nonaqueous liquids and solid formulahons (for which the manufactured drug product is the source of active ingredient), the beyond-use date is not later than 25% of the hme remaining unhl the product s expiration date or 6 months, whichever is earlier ... 

The use of pharmaceutics and most of the pharmaceutical or physicochemical factors involved in formulation of these products are identical. One exception, however, is the shorter beyond-use dates assigned to compmmded preparations as compared to expiration dates for manufactured products. A second notable exception is that commercially manufactured products are developed over several years whereas an extemporaneously compounded preparation may be required for a specific patient in a matter of minutes or hours. 

Subpart G, Labeling Control of Excess Products. If a quantity of a compoimded drug product is prepared in excess of that to be initially dispensed in accordance with Subpart A, the excess product shall be labeled or documented with the complete list of ingredients (components), the preparation date, and the assigned expiration date based upon professional judgment, appropriate testing, or published data. 

Whereas commercially manufactured products are required to possess an expiration date, compounded products are assigned a beyond-use date. There are numerous sources of information that can be utilized for determining an appropriate beyond-use date, such as chemical companies, manufacturers literature, laboratory data, journals, and published texts on the subject. Generally, most pharmacists prepare and dispense small quantities of compoimded products, recommend storage at room, cool, or cold temperatures, and use a conservative beyond-use date. 

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