Good manufacturing practices

FOR THE INDUSTRIAL PRODUCTION
OF FOOD AND FEED MICROORGANISMS

EFFCA members are committed to apply and respect a set of good manufacturing practices (GMP). These practices are described in a guide which deals with the 5 major steps of the production process (1) :

• Culture preservation and inoculum preparation.
• Production of the active biomass.
• Reception of the production from the fermented medium.
• Transformation of the harvested cells into the final form : solid or liquid forms (like freeze drying, deep freezing, etc…).
• Mixing formulations and packaging of the finished products.

The guide also covers general topics like personnel, control, quality insurance and bio-vigilance.

In order to guarantee a safe production of starter cultures, EFFCA members ensure that the multiplication and production of the microorganisms is carried out by well defined and tested processes under aseptic and hygienic conditions. These processes are validated by the personnel and supervisory staff.

The personnel must carry out routine operations with the utmost care, especially from the point of view of cleanliness and safety. It must respect strict constraints such as wearing protective suits, masks, gloves, glasses, etc… In order to avoid any contamination, all small material which has been used is systematically deposited in a special container until final disinfection or destruction. The staff must be trained and experienced in the techniques of cleaning, sterilisation, inoculum and medium transfer, sampling and draining equipments and installations as well as the handling of biomass during downstream processing and filling.

Contamination (an exceptional occurrence) may have substantial consequences on the quality and quantity of the biomass. Proper measures to be applied if contamination occurs are defined. The causes of the contamination are studied, the relevant equipment is sterilised and corrective actions implemented.

Measures are described to improve the prevention of defects.

The guide also proposes a system for the collection, validation and processing of all information relative to possible adverse effects on man and the environment linked to the production process, such as liquid effluents and waste products.

(1) EFFCA Guidelines for Good Manufacturing Practices  – EFFCA – 20-22 rue Brunel - CS 70080 – 75017 PARIS CEDEX 17 – Tel : 33 (0) 1 56 60 47 22 – Fax : 33 (0) 1 56 60 47 09