particular drug, it is essential that the equipment used is cleaned and tested for
adulterants before use. Many pharmaceutical manufacturers estimated that
production line equipment is only used to produce the product for about 10%
of its time. For most of the remaining time it is being stripped down, cleaned and
reassembled.
The quality control of drugs and medicines during and after production is
essential for their safe use. It was only achieved when accurate analytical
methods were developed in the mid-19th century. This led to the publication
of national pharmacopoeias and other documents that specified the extent and
the nature of the identification tests and quantitative assessments required to
ensure that the product reaching the public is fit for its purpose. These docu-
ments now cover the production, storage and application of pharmaceutical
products. They are the subject of constant review but unfortunately this does
not completely prevent the occurrence of product related problems. However,
the continual updating of these documents does reduce the possibility of similar
problems occurring in other products. It is gratifying to note that since the
thalidomide disaster very few drugs have been removed from the market on
safety grounds. The development of reliable analytical methods for the trials,
production quality control and identification, limit and assay procedures for
inclusion into the relevant pharmacopoeias is normally carried out in parallel
to the critical path development stages. These analytical methods must be
described in detail in the product licence application.
11.7 Patent protection
The high cost of drug development and production makes it essential for a
company to maximize its returns from a new drug. This can only be achieved by
preventing unrestricted copying of a new product by rivals. Patents are used to
prevent rival companies manufacturing and marketing a product without the
permission of the originator of the product. However, many companies do
market other manufacturers’ products under licence from the original patentor.
Patents have been used, in one form or another, as a means of industrial
protection from the early 14th century to the present day. Originally, they were
intended to encourage the development of new industries and products by
granting the developer or producer the monopoly to either use specific industrial
equipment or produce specific goods for a limited period. This monopoly,
enforced by the appropriate government office, enabled an innovator to obtain
a just reward for his efforts. In most countries the awarding of a patent prevents
236 DRUG DEVELOPMENT AND PRODUCTION