Division 3.4 Method of production and quality control

Full information on how the micro-organism is produced in bulk must be provided.

Both production method/process and product must be subject to a continuous quality control by the applicant. In particular, the occurrence of spontaneous changing of major characteristics of the micro-organism and of the absence/presence of significant contaminants shall be monitored. The quality assurance criteria for the production shall be submitted.

The techniques used to ensure a uniform product, and the assay methods for its standardisation, maintenance and purity of the micro-organism must be described and specified (e.g. HACCP).