Why is allergen control important in GMP?

• A. Preventing unintended allergen exposure by labeling, segregation, cleaning, and handling.
• B. Reduces production costs by removing all allergens.
• C. Increases shelf life by neutralizing allergens.
• D. Allows cross-contact to occur to test reactions.

Answer: (B)

Allergen control in GMP focuses on protecting people with allergies by preventing unintended exposure to allergens. This is achieved through clear labeling, segregation of allergenic ingredients from non-allergenic products, dedicated equipment or validated cleaning procedures, and careful handling and storage practices. Labeling helps the consumer make informed choices; segregation and dedicated equipment reduce the chance of allergen residues ending up in the wrong product; thorough cleaning removes any remaining traces; and proper handling minimizes cross-contamination risks throughout production and packaging.

The idea of reducing costs by removing all allergens isn’t the aim or a realistic goal, since many products legitimately contain allergens and you can’t rely on complete removal alone to ensure safety. Increasing shelf life by neutralizing allergens isn’t a function of allergen control, and letting cross-contact occur to test reactions is unsafe and against GMP principles.