1 reply to this topic

[ChelseaC]

Does anyone have an example of an Allergen Management plan that I could look at for an example. 

 

I am struggling with how to write this. Do I write this as listing what our plan is eg. identify allergen sources, allergen risk assessment, allergen control measures or am I writing what our plan is against these points?

 

 

[G M]

A lot of these are just references to other policies, but they're collected under an "Allergen Management" program just to acknowledge the risk of allergens.

 

I'd start with some basics.

• What kind of sanitation/cleaning procedures do you implement that control cross contamination (you probably do these for other reasons, but they also work against allergens)
• What scheduling approach do you take to limit cross contamination (none first, A second, A+B third; C on Monday-Tuesday, D on Wednesday)
• What kind of personnel or equipment segregation do you use, like color coding
• Based on which markets your product is consumed in, which allergens do the regulators recognize, and which do you handle in your facility
• List personnel GMP training that applies to allergen risks, like having people wash hands when returning from non production areas, changing gloves and PPE when moving between product handling on different lines

 

Then you can cover a few of the standard "what if's"

• Receiving and storage handling and inspection procedures
• Rework procedures
• Make some basic reference to your corrective actions policies for unacceptable incidents
• Who's doing the operational GMP monitoring, how often, etc.