ABSTRACT
Introduction This chapter endeavours to set out the important role of the pack and the need to consider the total packaging operation as part of any drug discovery and development programme. Although demands on the type of pack (material, style, etc.) will vary according to the characteristics of the product; how it is produced and distributed; where, how and to whom it is sold; how it is used/administered; etc., certain factors are shared irrespective of the product classification (i.e. ethical, over the counter (OTC), veterinary, etc.). Pharmaceutical products generally require a standard of packaging which is superior to that of most other products in order to support and comply with their main requirements, i.e. proven efficacy, safety, uniformity, reproducibility, integrity, purity with limited impurities, minimum side-effects coupled to minimum product liability risks, and a good shelf-life stability profile. Since all these terms tend to be well established, but not always fully understood, it may be useful to emphasise the importance of each and its relevance to product pack development. Thus although packaging technology may be a clearly defined discipline, it must have as its basis a thorough understanding of pharmaceutical products generally, the characteristics of formulations and dosage forms, and the general physical and chemical properties of drug substances. Such background detail must include factors associated with medical and marketing input, the methods of manufacture and packaging, warehousing and distribution, sale, the ultimate customer and product use, coupled to adequate profitability. Quality associated with aspects of good manufacturing practice has to be clearly defined at all stages. This chapter therefore starts with some background information.
