These guidelines are intended to complement those provided in “Good manufacturing practices for pharmaceutical products” (1).
The regulatory procedures necessary to control biological products are in large part determined by the sources of products and methods of manufacture. Manufacturing procedures within the scope of these guidelines include:
- growth of strains of microorganisms and eukaryotic cells,
- extraction of substances from biological tissues,
- including human,
- animal and plant tissues (allergens),
- recombinant DNA (rDNA) techniques,
- hybridoma techniques,
- propagation of microorganisms in embryos or animals.
Biological products manufactured by these methods include allergens, antigens, vaccines, hormones, cytokines, enzymes, human whole blood and plasma derivatives, immune sera, immunoglobulins (including monoclonal antibodies), products of fermentation (including products derived from rDNA) and diagnostic agents for in vitro use.