I-MuPGO 31K (3761D)

GMP Operating Procedures Title: Allergen Control GMP: 100-12 Written By: E.Glenn Approved: signature on file Date: 3/8/17 Rev. No.: 4 __________________________________________________________________________ Ivanhoe Industries Inc. 3333 20th St. Zion, IL 60099 1 1.0 Purpose 1.1 To define the proper education on allergenic materials. 2.0 Scope 2.1 This procedure applies to the Zion Facilities. 3.0 Requirements 3.1 Suppliers and Raw Materials 3.1.1 Maintain a list of allergens present within the facility, updating the list when necessary. 3.1.2 This information is found on the Approved Suppliers List located in the J:Drive/Common Forms. Any allergen in the facility will be identified on this list by having vertical red lines through the entry. 3.1.3 Request and obtain allergen documentation from suppliers on raw materials. 3.2 Receiving and Storage 3.2.1 All allergens must be clearly marked with a fluorescent colored label marked ‘ATTN ALLERGEN’ and a QC approval label. 3.2.2 Approved allergens must be in clean, sealed containers, and placed in a designated area in the facility. 3.2.3 Currently all allergens and allergen containing products are housed at 1916. 3.3 Production and Scheduling 3.3.1 Ivanhoe no longer producing finished goods, using any allergenic material. 3.3.2 In the event Ivanhoe would encounter an opportunity to manufacture with an allergen, the following would take place: 3.3.2.1 Production must have a designated upright kettle for allergen containing product. Product will be charged by dumping, so it is not necessary to involve any hoses. Color coding/clearly labeling equipment is necessary. 3.3.2.2 Personnel working on a batch containing allergen must focus on that batch until finished, to avoid cross-contamination of allergen products. 3.3.2.3 When manufacturing an allergenic product, it is necessary to document that the equipment was properly sanitized before and after manufacturing the batch.

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