The legal status of investigational pharmaceutical products for human use
varies from country to country; in some of them, these products are manufactured
and inspected like "normal" licensed pharmaceutical products. In most countries,
however, they are not covered by legal and regulatory provisions in the areas of
good manufacturing practice (GMP) inspection, etc.
However, the EC guide on GMP recommends that the principles of GMP should be
applied, as appropriate, to the preparation of these products, and the WHO guide
on GMP, according to the statement in the general considerations is applicable
to "the preparation of clinical trials supplies". The present guidelines
supplement both the WHO guide on GMP and the guidelines on good clinical
practice (GCP) for trials on pharmaceutical products. The application of the
principles of GMP to the preparation of investigational products is necessary...