Halal Assurance System (HAS)

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1.0 Purpose 
 The procedure defines the Halal Assurance System (HAS). The Halal Assurance System
 
 complies with the specific requirements to manufacture Halal products. 
 
 2.0 Scope 
 
 This procedure applies to all selected materials, approved suppliers, purchasing, receiving,
 storage, processing, packaging, and shipping for all Halal products manufactured and packaged
 
 by Ion Nutritional Labs. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of all employees to follow this procedure.
 
 3.2 It is the responsibility of the Halal Management Team (i.e. Halal Committee) to
 implement, evaluate, make decisions, and continuously improve the Halal Management
 
 System. 
 
 3.3. It is the responsibility of Head of Quality to appoint and maintain an active Halal
 
 Committee. 
 
 3.4 It is the responsibility of all department Heads, Managers, and Supervisors to implement
 this procedure to ensure the control of storage, processing, and packaging of Halal
 
 products. 
 
 3.5 It is the responsibility of Purchasing personnel to receive proper documentation for Halal
 
 materials prior to receiving. 
 
 
 

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 3.6 It is the responsibility of Warehouse personnel to ensure any Halal materials received
 have proper documentation, are identified, and materials are stored in a designated
 
 location. 
 
 4.0 Definitions 
 
 4.1 IFANCA -— Islamic Food and Nutrition Council of America 
 
 4.2 Halal — Arabic term meaning permitted or allowed 
 
 4.3 Mashbooh — Arabic term meaning doubtful, suspect, or questionable 
 
 4.4 Haram — Arabic term meaning forbidden, not permitted, or not allowed
 
 4.5 Halal Assurance System — a systematic approach to identify non-halal contamination
 
 and control measures to ensure halal and safety status of products
 
 4.6 QA — Quality Assurance 
 
 5.0 References 
 
 Sul A-108, SOP, Good Manufacturing Practices and Personal Hygiene 
 
 Saas A-113, SOP, Training Procedure 
 
 5.3 A-118, SOP, Management Review of Quality Metrics 
 
 5.4 B-105, SOP, Preparation of Cleaning and Sanitizing Chemicals for Production and
 
 Warehouse 
 
 5.5 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment
 
 5.6 C-104, SOP, Master Batch Record and Issuance of Batch Production Record
 
 Sod C-201, SOP, Deviation and Investigation Procedure 
 
 5.8 C-502, SOP, Record Storage, Retention, and Destruction 
 
 
 

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 5:2 C-707, SOP, Critical Control Point Specifications 
 
 5.10 E-101, SOP, Warehouse and Inventory Control 
 
 Dull E-204, SOP, Receiving Process for Raw Materials and Packaging Components
 
 5.12 E-703, SOP, Raw Material Sampling Procedure 
 
 5.13 QS-105, SOP, Food Safety Plan 
 
 5.14 QS-107, SOP, Recall Procedure 
 
 515 QS-108, SOP, Corrective and Preventative Action 
 
 5.16 IFANCA Porcine-Free Environment Policy, IFANCA-Ref 57 
 
 6.0 HAS Table of Contents 
 
 6.1 Section 7.0: Halal Quality Policy 
 
 6.2 Section 8.0: Halal Management Team 
 
 6.3 Section 9.0: Training and Education 
 
 6.4 Section 10.0: Halal Certified Product 
 
 6.5 Section 11.0: Raw Material 
 
 6.6 Section 12.0: Production Facilities 
 
 6.7 Section 13.0: Critical Activity Procedure 
 
 6.8 Section 14.0: Traceability & Recall/Withdrawal Plan 
 
 6.9 Section 15.0: Handling of Non-Halal and Nonconforming Materials 
 
 6.10 Section 16.0: Internal Audit 
 
 
 

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 6.11 Section 17.0: Management Review 
 
 7.0 Halal Quality Policy 
 
 7.1. Ion Nutritional Labs is committed to producing Halal products in compliance with Halal
 
 Guidelines issued by the Islamic Religious authorities. Ion Nutritional Labs will ensure
 Halal Integrity of food processes starting from the control of raw materials to
 
 manufacturing, packaging, storing and distribution. We strive to ensure that all of our
 Halal products are safe for human consumption through continuous improvement.
 
 8.0 Halal Management Team 
 
 8.1 A Halal Committee has been appointed. The Halal Committee has the ability to
 implement, evaluate, make decisions, and continuously improve the Halal Management
 
 System. A Halal Committee shall have a lead member to assign responsibilities when
 
 conducting activities. 
 
 8.2 Each member of the Halal Committee shall have proper knowledge/training of Halal
 
 Requirements. 
 
 8.3 The Halal Committee will meet once per year or if there is a change to operational
 
 procedures that may affect halal products. 
 
 9.0 Training and Education 
 
 9.1 QA/Training Department shall provide all employees Halal Awareness Training during
 
 the Annual GMP Training. Training materials are evaluated to ensure employees are
 trained to any updated Halal Requirements. 
 
 9.2 Halal training will be included with New Hire Training. 
 
 9.3 All training is documented and maintained by the QA/Training Department per SOP A-
 
 113 Training Procedure. 
 
 
 

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 10.0 Halal Certified Product 
 
 10.1 Ion Labs will maintain a list of all products under Halal Certifications, including:
 
 10.1.1 A list of products using the same equipment as those under halal certification.
 
 10.1.2 A list of products repacked, relabeled, and/or stored in the same facility.
 
 10.2 Potential Halal certified product labels shall be sent to IFANCA for review prior to
 
 production. 
 
 10.3 QA will maintain Halal Certificate or Statement for registered Halal products.
 
 10.4 Production Batch Records will identify Halal products. 
 
 11.0 Raw Material 
 
 i] Materials used for Halal products must not be derived from or contain any Haram
 
 (forbidden): 
 
 11.1.1 Pork and/or any of its derivatives 
 
 11.1.2 Alcoholic beverages 
 
 11.1.3 Blood and its products 
 
 11.1.4 Carrion or products from Carrion 
 
 11.1.5 Carnivorous Animals 
 
 11.1.6 Any/all parts of human body 
 
 Li2 Ion Labs utilizes an electronic system for inventory status of all raw materials and
 
 packaging components. A list of products may be available upon request. Refer to SOP
 E-101 Warehouse and Inventory Control. 
 
 
 

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 12.0 Production Facilities 
 
 12.1 Ion Nutritional Labs will maintain a list of all production lines within the facility that are
 used for Halal products. Production lines will be segregated to prevent cross
 
 contamination of porcine materials. 
 
 12.2 Ion Nutritional Labs has two locations in Florida; 8031 114 Ave. Largo, FL 33773
 
 (manufacturing and shipping) and 19050 Belcher Rd. S Seminole, FL 33777 (warehouse,
 
 receiving, storage, weighing/dispensing and shipping). 
 
 13.0 Critical Activity Procedure 
 
 13.1 Material Purchasing 
 
 13.1.1 Financial records supporting the purchase and procurement of raw materials and
 packaging items used in the production should be retained for 6 years per SOP C-
 
 502 Record Storage, Retention and Destruction. 
 
 13.2 Incoming Material Checking 
 
 13.2.1 Incoming materials shall be compared to the packing list and Batchmaster item
 description. Warehouse associate will verify the material. Checklist includes:
 
 13.2.1.1 Material Name 
 
 13.2.1.2 Manufacturer name and address 
 
 13.2.1.3 Country of Origin 
 
 13.2.1.4 Halal Logo (if applicable) 
 
 13.2.1.5 Halal Certificate (if applicable) 
 
 
 

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 13.2.2 Ingredients that are intended for use in the manufacturing and packaging of Halal
 products must be identified as Halal and placed into the designated storage area as
 
 to prevent them from being mixed or contaminated with haram materials
 (materials that are not Halal e.g. porcine). Refer to SOP E-204 Receiving Process
 
 for Raw Materials and SOP E-101 Warehouse and Inventory Control.
 
 13.3 Production 
 
 13.3.1 Standard operating procedures are written for production operations. Refer to
 
 Standard Operation Procedures Section B - Manufacturing. 
 
 13.3.2 Process Flow Diagrams are maintained by QA and have documented CCPs.
 
 13.4 Production Facility Cleaning 
 
 13.4.1 Cleaning procedures are written and available for review by all employees. Refer
 
 to SOP B-111 Cleaning of Manufacturing/Production Areas and Equipment. All
 detergents, sanitizers, and cleaning chemicals that are potentially used for food
 
 contact surfaces are kept on file. 
 
13.4.2 Halal and non-Halal items (e.g. bovine) are manufactured at Ion Nutritional Labs.

 Major cleaning will be conducted between Halal and non-Halal items per SOP B-
 111 Cleaning of Manufacturing/Production Areas and Equipment, with no
 exceptions. Equipment used to manufacture and package Halal products shall not
 
 be shared with porcine materials. 
 
 13.4.3 An Approved Chemical and Lube list is maintained by the Sanitation Department.
 Refer to SOP B-105 Preparation of Cleaning and Sanitizing Chemicals for
 
 Production and Warehouse. 
 
 14.0 Traceability & Recall/Withdrawal Plan 
 
 Procedures are in place to ensure product traceability, one-step forward and one-step
14.1 backward.

 
 

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 14.2 Ion Nutritional Labs has established a Recall Procedure to perform a recall to remove or
 correct consumer products that are in violation of Islamic laws or laws administered by
 
 the Food and Drug Administration in compliance with FDA 21 CFR part 7. Two mock
 recalls are performed annually as a traceability exercise. Reference SOP QS-107 Recall
 
 Procedure. 
 
 14.3 A traceability exercise (trace forward and backward) will be conducted annually on a
 Halal finished product. 
 
 14.4 Ion Labs will notify IFANCA within 24 hours of learning of either a planned or in-
 progress recall/withdrawal of IFANCA certified products. IFANCA will be provided with
 
 a list of product(s) involved, with a detailed identification of nonconformity.
 
 A post recall will be provided to IFANCA as soon as possible. Information shall include:
14.5 14.5.1 List of products involved
 
 14.5.2 Identification of nonconformity 
 
 14.5.3 Cause of nonconformity 
 
 14.5.4 Evaluation of the need for action to ensure recurrence of nonconformity does not
 
 occur 
 
 14.5.5 Determination and implementation of needed actions 
 
 14.5.6 Recording and reviewing of the results for the actions taken
 
 15.0 Handling of Non-Halal and Nonconforming Materials 
 
 Ion Nutritional labs has established written procedures to control nonconforming
15.1 products. Refer to SOP C-201 Deviation and Investigation Procedure.

 
 

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 15.2 If the nonconformance is related to the Halal status of the product, Ion Nutritional Labs
 shall not label/market the product as Halal or rework the product into another batch of
 
 product to be labeled/market as Halal. 
 
 16.0 Internal Audit 
 
 16.1. A Halal internal audit will be conducted and documented, at a minimum, once per year,
 
 to verify Ion Nutritional Labs fulfills the requirements of IFANCA Halal certification and
 that the HAS is effectively implemented and maintained. Audit reports shall be made
 
 available for IFANCA upon request. 
 
 17.0 Management Review 
 
 17.1 Management Review activities will be conducted, at a minimum, once per year, to ensure
 
 the suitability and effectiveness of the HAS. Reviews shall include:
 
 17.1.1 Follow up action from previous management reviews 
 
 17.1.2 Changing circumstances which may affect halal production 
 
 17.1.3 Review of customer complaint data 
 
 17.1.4 External audit results 
 
 18.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/23/23 | New procedure. N/A C. Horelle | - | - |