Quality control of fungal and viral biocontrol agents - Assurance of product performance

An essential feature of the production of all microbial control agents is a n effective quality control system. Well-defined product specifications wit h accompanying quality control procedures help to maximize product performa nce, ensure product safety, standardize manufacturing costs and reduce the risks of supply failure, thus building user confidence. A production system that does not have a quality control system is one whose output is uncontr olled and a lack of thorough quality feedback can result in batches of prod uct with variable concentrations of active agent. This results in products with variable performance leading to control failures by users and serious loss of user confidence. Strict quality control procedures are not only ess ential for product consistency, but also for safety. Where quality control is inadequate, microbial contamination of the final product is inevitable. In most of such cases this will merely lead to a loss of efficacy due to di lution of the active ingredient by competing microorganisms, but also the p otential of producing human pathogens must be ruled out. Recognition of con taminants and quantification of the degree of contamination are therefore i mportant in determining any possible risk to human health. Many low technol ogy production systems in use around the world have minimal or no quality c ontrol procedures. This is unacceptable and can damage the reputation of mi crobial control in addition to possibly posing health risks to those that p roduce or are exposed to the product. Two case studies from developing coun tries, are used to illustrate how the lack of quality control procedures ca n lead to the production of low viability, highly contaminated products wit h low or negligible concentrations of the active ingredient. However, it is also demonstrated that low technology production systems in developing cou ntries can produce high quality products, provided appropriate quality cont rol procedures are firmly implemented. It must be recognized that quality c ontrol procedures can be more complex and technologically demanding than th e production procedures themselves, but it is largely on the effectiveness of these control procedures that the long-term acceptability of fungal and viral products depends. This paper details the quality control procedures c onsidered necessary in the mass production of fungi and viruses for use as biocontrol agents, and attempts to suggest reasonable standards that can be achieved by all producers.