PubMed · 11407322
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G T Budd. 2000. Web alert.. https://pubmed.ncbi.nlm.nih.gov/11407322/
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I address 2 important topics of current good manufacturing practices as they apply to vaccine products: product inspections and stability testing. The perspective presented is that of regulated industry. There are 2 major categories of product/facility inspections: those occurring before licensure of a vaccine product and those occurring after a vaccine product is licensed. The logistics and focus of each inspection type, the preapproval inspection, and the required biennial inspection are discussed, as are guidance and recommendations for achieving successful inspections. The requirements, guidance, and recommendations regarding the type, amount, and extensiveness of stability data for vaccine products are presented. The discussion details the potential differences in the amount and type of data required for products that are not yet licensed versus marketed products. Guidance, from a regulated industry perspective, regarding the design and implementation of a successful stability program is also discussed.
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The availability of drugs on an over-the-counter basis, including those previously available only by prescription, provides patients with improved access to effective therapies. Removal of the requirement for prescriptions saves both the health care professional and the patient time. However, the overall effect on health care costs is complex. One such effect may be that costs shift from third-party payers to patients. In addition, short-term cost savings may be offset over the long term by problems due to inappropriate use or suboptimal therapy. Optimal therapy with an over-the-counter drug requires that the consumer diagnose the underlying condition correctly and use the drug in a manner that minimizes risk. Assessment of the ability of patients to use drugs in this manner is a critical component of the regulatory review of over-the-counter drugs. The available data arouse the concern that without the supervision of a health care professional, some patients may not be able to use over-the-counter drugs appropriately for certain diagnoses or chronic conditions or in high-risk situations. On the other hand, the widespread use of over-the-counter aspirin on a long-term basis for cardiovascular-risk reduction illustrates the potential value of increased drug availability for long-term therapy. Advances in technology may facilitate the growth of over-the-counter drug therapy. For example, the wide availability and acceptance of reliable methods for measuring serum cholesterol in nonmedical settings may eventually contribute to the safety and effectiveness of over-the-counter treatments for hyperlipidemia. Thus, the future promises increases in the number of drugs available over the counter and in the variety of indications for their use.