Good Manufacturing Practice [CFR title 21, Part 110 (1986)]
With annual GMP Audits conducted by AIB International, BioSynergy’s manufacturing facility continued to be in compliance with standardized Good Manufacturing Practices (GMP) receiving an “Excellent” rating.
Annual comprehensive third party GMP audits evaluate:
Food and Supplement Safety Program
Maintain an effective food and supplement safety program reducing the potential for product contamination in the plant. This program documents the maintenance and continuous improvement of the required programs for product safety.
Requires using a formalized, written food and supplement adulteration prevention program to conform with consolidated standards. Programs, records, and procedures are followed to prevent product adulteration by pests, pest evidence, or pesticides.
Operational Methods and Personnel Practices
Specific programmed techniques are required to protect food and supplements from adulteration during storage and manufacturing. These programs address tracking, receiving and storing raw materials; transferring and handling ingredients; operational appearance; and operational, delivery, and personal practices.
Maintenance for Food and Supplement Safety
Requires the plant to have an established and implemented preventive maintenance program; documented maintenance system; and safety/hygenic design criteria for the building, equipment, and utensils to prevent food contamination from these sources.
Requires scheduled cleaning of the building and grounds, equipment, utensils, and maintenance cleaning associated with electrical mechanical systems.