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1. Cross contamination with active ingredients Contamination of one batch of product with significant levels of residual active ingredients from a previous batch cannot be tolerated. In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds While inert ingredients used in drug products are generally recognised as safe or have been shown to be safe for human consumption, the routine use, maintenance and cleaning of equipments provide the potential contamination with such items as equipment parts, lubricants, chemical cleaning agents and pieces of cleaning tools such as brushes and rags.
3. Microbiological contamination
Maintenance, cleaning and storage conditions may provide adventitious micro organisms with the opportunity to proliferate within the processing equipment.
