Quality assurance of products manufactured by recombinant DNA technology. Introduction and elements of a philosophy.

The risk of gene technology has been overrated, leading to regulations which are unnecessarily strict. Industry can contribute to relaxation of such controls by making its experiences in production available to the authorities concerned. Good manufacturing practice (GMP) for large scale operations mainly covers the risks of gene technology in industrialised countries; to what extent this also applies to developing countries is not yet certain. Quality assurance of recombinant DNA technology derived products requires control of the starting materials (host organism and DNA vector), manufacturing process and final product. The host organism and DNA vector are beyond pharmacopoeial control; this control must be exercised by the competent national authorities, concerned with licensing of pharmaceutical production. The same applies to the validation of methods designed to exclude viral contamination during manufacture. The risk of introducing DNA-engineered organisms into the environment remains to be studied. Application of gene technology in the development and production of pharmaceutical products does not call for rigid directives, but for guidelines and lists of "Points to consider".