A-108
Good Manufacturing Practices and Personal Hygiene
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1.0 Purpose The purpose of this procedure is to establish the requirements for all personnel to be in compliance with FDA regulations, cGMPs, company policies and procedures, and special certification requirements which apply to the manufacturing, packaging, holding, and distribution of dietary supplements and pet products. 2.0 Scope This procedure applies to all employees, visitors, and contractors of Ion Nutritional Labs. 3.0 Responsibility Sol It is the responsibility of all personnel to follow this procedure. 3.2 It is the responsibility of the Ion Nutritional Labs associate to advise planned auditors, visitors, or contractors of dress code requirements prior to arrival to ensure proper adherence to safety and GMP requirements. The Ion Labs associate is to provide Addendum I, Contractor/Visitor Agreement to the auditor, visitor, or contractor. 3.3. It is the responsibility of Department Heads, Managers, and Supervisors to implement this procedure and ensure compliance by all personnel with the requirements set forth in this procedure. 3.4 It is the responsibility of Management and Quality to ensure this procedure is being followed. [SOP Standard Operating Procedure SOP No Rev No Page Good Manufacturing Practices and Personal Hygiene A-108 17 2 of 20 4.0 Definitions 4.1 cGMP — Current Good Manufacturing Practice 4.2 PPE — Personal Protective Equipment 43 HR — Human Resources 4.4 IT - Information Technology 4.5 Gemba Walk — a workplace walkthrough which aims to observe employees, ask about their tasks, and identify productivity gains, safety concerns, or quality concerns that require additional attention 5.0 References | A-107, SOP, Workplace Safety Procedure Sud A-104, SOP, Emergency Preparedness 33 A-113, SOP, Training Procedure 5.4 F-510, SOP, Sharp Instrument Control Procedure 5.5 QS-105, SOP, Food Safety Plan 5.6 QS-106, SOP, Allergen Control 5.7 QS-109, SOP, Food Defense Plan 5.8 G-104, SOP, Lockout/Tagout Procedure 3.0 21 CFR Parts 111, 114, 117, 507 - as applicable to Dietary Supplements and Pet Products (reference FDA CFR -Code of Federal Regulations Title 21 for specific part reference) 5.10 Florida State Department of Agriculture Chapter Title: Food —Administrative Code: 5K- [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 3 of 20 4.004 General Requirements for the Manufacturing, Processing, Packing, Holding and Retailing of Foods 5.11. Addendum 1, Contractor/Visitor Agreement 5.12 Addendum 2 - GMP Exemption Form 6.0 Procedure 6.1 Manufacturing Area Requirements 6.1.1 Utilize the GMP Facility Layouts (Attachment 1 and 2) and GMP Requirement Chart (Attachment 3). Personnel engaged in manufacturing, packaging, labeling, testing, or holding of product at Ion Labs must wear clean clothing appropriate for the duties they perform for personal safety, and to protect against product contamination. 6.1.2 All personnel, including all visitors and contractors entering the manufacturing area must wear required PPE; a clean frock/lab coat and/or uniform, hairnet, (beard cover, if required), mask (if applicable) and dedicated shoes (identified with a provided shoe tag/mark) or shoe covers. These items are located in designated areas. PPE should be worn properly to prevent contamination. As a safety and security measure, all visitors and contractors are required to sign in and out at the lobby at FL Building #1 and dock A at FL Building #2. A visitor ID tag must be worn when on the property (tag is disposable and includes photo, name, date and time). Contractors/Visitors must read and sign Addendum I, Contractor/ Visitor Agreement (return form to Facility Manager or QA). Contractors/Visitors must be accompanied/monitored by a designated employee. IT will run and distribute a daily report to employees who have received guests, to ensure that they have left the building. Associates who have guests must ensure that they sign out. [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 4 of 20 6.1.4 All production personnel and QC inspectors must leave their personal items (e.g. phones, purse, keys-with the exception of keys associated with Lock-out/Tag- Out, management approved medicines) in designated lockers or secured areas unless otherwise approved by Management. Phones that are approved by management must be free of embellishments (studded, sequined or jeweled). 6.1.5 Personnel are permitted to not button the top button of their uniform, if a shirt is worn under the uniform that covers the open area of the uniform and the shirt has no buttons or embellishments exposed. Personnel performing work that elevates their waist to or above product height are required to have all frock buttons fastened below the waist. 6.1.6 Hairnet Assignment 6.1.6.1 Color coding of hairnets identifies the visitor/contractor/temp or employee’s role: o Red, Blue, Orange and Yellow — based on department level e White — Visitors, Contractors, Management, Maintenance, Quality ° Green — Temp Note: Due to vendor supply shortages, certain colors of hairnets may not be readily available. Employees will wear another color that is available, temporarily. Other material type hairnets may be purchased depending on production needs and must be approved by Quality Management prior to being allowed on the production floor. 6.1.6.2 Employees are properly trained in their current job role per designated hairnet color. All transfers/promotions should be documented and the document approved by department management, training department, [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 5 of 20 and HR. HR retains the form (Employee Status Update Form-see form for details). 6.1.7 Frocks, gloves, hairnets, beard covers, masks, or dedicated shoes should not be worn outside the designated production area. The exception to this rule is as follows: 6.1.7.1 Dedicated shoes may be worn outside of the production areas, but must be covered with appropriate shoe covers prior to entering breakrooms and restroom. Dedicated shoes (even with shoe covers) must not be worn outside of the facility and cannot leave the property. Shoe covers will be disposed of and new shoe covers donned prior to re-entering the production area (unless dedicated shoes are worn). 6.1.72 Fire Drill or Emergency Evacuations: Dedicated shoes that must be worn outside due to a fire drill or emergency must be sanitized before entering the manufacturing area. Inspect shoes and remove any solid debris if reasonable. Use 70% IPA on all surfaces of the dedicated shoes to effectively sanitize them (Refer SOP A-104 Emergency Preparedness). 6.1.7.3 Frocks / coats / hairnets / beard covers / masks / dedicated shoes / shoe covers / leg coverings (unless being worn to cover dedicated shoes in restrooms/breakrooms) / gloves may not be worn in the restrooms, breakrooms, or outside of the facility (with the exception of an emergency evacuation or fire drill). Hooks are provided outside production areas and restrooms. If frocks/coats, hairnets, beard guards, or gloves are worn outside the building during a fire drill, they must be exchanged for new ones prior to re-entering the production area. 6.1.7.4 Frocks/coats must be properly stored in designated areas when removed. [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 6 of 20 6.1.7.5 Coats are not to be worn when handling product or product-contact materials. Associates must wear production frocks if they are handling product or product-contact materials. 6.1.7.6 Frocks are changed daily for the following areas: 6.1.7.7 Blending 6.1.7.8 Compression 6.1.7.9 Encapsulation 6.1.7.10 Coating 6.1.7.11 Liquids 6.1.7.12 Bulk Powder Filling 6.1.7.13 Gummies 6.1.8 Frocks are changed twice a week for Primary Packaging Areas where product is exposed (e.g. filling/bottling). 6.1.6 Employees that are issued uniforms must change their uniform daily or when heavily soiled. 6.1.7. Employees that are issued lab coats should change coats when visibly soiled or contaminated. 6.1.8 Visitor lab coats will be cleaned as necessary. 6.1.9 Frocks and issued uniforms with pockets above the waist are not allowed. No items shall be stored above the waist, including but not limited to: pens, badge clips, etc. 6.1.10 Nitrile impermeable gloves must be worn when working with open product, [SOP Standard Operating Procedure SOP No Rev No Page Good Manufacturing Practices and Personal Hygiene A-108 17 7 of 20 weighing materials, or when handling open primary packaging components. Wear gloves as appropriate and maintain them in an intact, clean and sanitary condition. Gloves must be replaced when soiled or damaged. If leaving a room with gloves and returning immediately, clean with a light spray of alcohol prior to beginning work. Gloves need to be changed after handling a food allergen and prior to handling any another product. 6.1.11 Used/soiled frocks will be placed in designated hampers located by the restroom/changing area. Disposable frocks, coats, or jumpsuits may be worn as needed and should be discarded after use. 6.1.12 Maintenance personnel must wear clean company-provided uniforms, or clean frocks when repairing or calibrating equipment with open or exposed product (e.g. pill or component hoppers). All other PPE is required when performing maintenance in a room with open product (i.e. mask, gloves, beard nets / hairnets). If work cannot be completed with the required PPE, open product must be removed from the room or area. Cleaning must be performed on the equipment where the work was being done prior to open product being re-introduced to the room. If company-provided uniforms have been worn outside of the facility, they are no longer considered clean and a frock must be donned prior to performing maintenance activities in a room with open product. 6.1.13 All masks used will be in accordance / compliance with appropriate regulations and procedures. Masks are to be worn at all times in production rooms/areas that house open product. Respiratory protection items should be cleaned/stored properly while not in use. Masks are required for equipment and room cleaning when sanitization activities begin. 6.1.14 Ear protection is available, where applicable. Ear protection must be kept clean and stored properly. 6.1.15 Protective eyewear is made available to all employees. Protective eyewear must [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 8 of 20 be worn in liquid blending, during powder/liquid filling operations and when cleaning equipment. Protective eyewear must be worn in the laboratory at all times. Protective sleeves or gloves pulled over the end of frock sleeves must be worn whenever personnel are in contact with raw material (e.g. weighing/blending, encapsulation, tableting, coating, liquids, sieving). Protective eyewear is required if an employee working with open product or product-contact equipment is wearing false eyelashes. 6.1.16 Any corrective glasses not worn on the face must be stored below the waist or be secured around the neck with quick release eyewear strap. Glasses must not be worn on top of the head or hooked to the front of the coat / frock / uniform. 6.1.17 Dedicated shoes should be closed-toe, closed-heel, non-skid shoes, and preferably black. Once dedicated work shoes are approved by Quality, a visible orange tag or marking is placed on the shoe. 6.1.17.1 Certain departments require steel toe or composite shoes. These departments are: e Warehouse e Shipping/Receiving e Maintenance e = Facility Tech. 6.1.17.2 Some exceptions may exist for different job functions and must be approved before use by Quality or Production Management. 6.1.17.3 Dedicated shoes are to be covered by shoe covers when working in rooms containing allergen materials. These shoe covers are to be removed immediately upon exit of the room to prevent cross- [SOP Standard Operating Procedure SOP No Rev No Page Good Manufacturing Practices and Personal Hygiene A-108 17 9 of 20 contamination of allergens into the facility. New shoe covers will be donned before re-entering the room containing allergen materials. 6.1.18 Shorts, capri pants, ripped clothing, strapless tops, sandals, embellished clothing (e.g. Studded, sequined, jeweled), hats, and high heels are not allowed in the production area. Clothing and frocks/lab coats should provide coverage of legs and arms at all times. 6.1.18.1 Head coverings that are required for employee personal reasons may be requested and allowed by Management, under certain stipulations, which will be documented on Addendum 2 GMP Exemption Request Form. 6.1.19 Personal, non-work related items, including miscellaneous clothing items, are not allowed in production areas at any time. 6.1.20 Remove all jewelry and other unsecured objects (e.g. watches, ear buds). Jewelry such as rings, bracelets, earrings, piercings on exposed areas of the body (e.g. face, nose, tongue, hands), and necklaces are not permitted in the manufacturing area. If hand-jewelry cannot be removed, it must be covered by gloves at all times to protect against contamination of components, products and surfaces. Any type of permanent jewelry must be covered. Exception to this rule is as follows: 6.1.20.1 Medical information jewelry that cannot be removed and is worn in the production area must be covered so it does not pose a risk of contamination to product, raw material, or packaging components. 6.1.20.2 Lifesaving drugs such as an EpiPen or asthma inhalers are allowed after clearance by HR. 6.1.21 All warehouse, shipping, facility, or any personnel operating a forklift must wear reflective apparel. [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 10 of 20 6.1.22 Knives and sharps (e.g. box cutters) must be cleaned, intact and used appropriately (no wood utensils allowed). Refer to SOP F-510 Sharp Instrument Control Procedure. 6.1.23 Different colored containers are designated for specific processes throughout production. The color specifications are as follows: (Attachment IV) Grey & White Containers w/Liners Powders, Capsules, Tablets (product) Yellow Containers- Trash Blue Containers- Product Waste Green Containers- Liquids (product) Orange Containers- Clean Rags Red Containers- Dirty Rags Light Blue Containers- Utility Use (water for cleaning, hold water waste, to place utensils in during processing, etc.) Container color may vary due to volume of production. Containers need to be properly labeled. Labeling of containers will occur at the container storage point, prior to being taken to the point of use. 6.2 Allergen Controls 6.2.1 Ion Nutritional Labs maintains an Allergen Control Program. Employees, Visitors, and Contractors must comply with the Allergen Control requirements to prevent cross contamination. Refer to QS-106 Allergen Control. 6.3. Handling Illnesses and Injuries [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 11 of 20 6.31 Any person with a known illness, infection, open lesion, wound, or any other potential source of contamination, must be excluded from any production operations that would expose product to contamination risks. It is the responsibility of an employee to inform their Supervisor of any illness or symptoms prior to the start of their shift or if they become ill at any time during their shift. Visitors or contractors with symptoms/known illness should be excluded from the production area. 6.3.2 Personnel that need to be absent from work must contact and notify the HR per company policy by calling the designated number listed in Employee Handbook. 6.3.3 Any Injury/Accident/IlIness should be reported immediately to a Supervisor and HR. Refer to SOP A-107 Workplace Safety. 6.4 Hygienic Practices 6.4.1 All personnel must maintain adequate personal cleanliness. Please refer to the employee handbook for general expectations. 6.4.2 Wash hands thoroughly using provided antibacterial soap and sanitize prior to starting work, after using the restroom, after eating, drinking, and use of tobacco products or vaping devices, after each absence from the work station, and at any time when their hands may have become soiled or contaminated. Hands must be washed at dedicated hand washing sinks prior to an employee starting work in their department. Hands must be sanitized after washing/drying to protect against contamination with undesirable microorganisms. 6.4.3 Dedicated hand washing sinks can only be used for hand washing. Hand sinks must be clean and in good repair and properly supplied at all times with clean hot water, antibacterial soap, disposable paper towels, hand washing instructions, and a hands-free trash can. 6.4.4 Nail polish and artificial nails are permitted only if completely covered at all times [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene | 4-108 17 | 12 of 20 by disposable gloves while in the production area. Nail embellishment is not allowed. Artificial nails must not be excessive in length and shape must be appropriate as to not puncture glove. Gloves are provided upon entry into the production area and must be worn appropriately. Should damage to the glove occur, replace immediately. This policy also applies to guests/visitors where applicable. 6.4.5 False eyelashes are only allowed in production areas with the use of safety glasses. 6.4.6 Food, gum, candy, beverages, plants, and medicine (unless approved by management) are not allowed in the production area at any time. Food may be consumed in designated desk area in the QC Lab. These items (excluding tobacco products) cannot be stored in lockers. Random locker inspections may be conducted by a management representative of Ion Nutritional Labs at any time. 6.4.7 Smoking or vaping is only allowed in designated smoking areas outside of the facility. Receptacles for waste associated with these activities are provided and must be used. 6.5 Access to Restricted Areas and Security 6.5.1 Access to the production and warehouse areas is restricted to authorized personnel only. 6.5.2 All visitors and contractors must be accompanied/supervised by an Ion Nutritional Labs employee at all times unless they have signed the Contractor Agreement for Facility Access form. 6.5.3 Contractors must review and sign a Contractor Agreement for Facility Access form, provided upon arrival at the facility, prior to performing work. This form will be retained for future reference and in the event that contractual work is extended over a defined period of time. [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 13 of 20 6.5.4 The use of cell phones, photography, or video recording devices by employees, visitors, or contractors is forbidden in the production area unless approved by Management. Hand held two-way radios are issued by the Facility Manager for use by authorized personnel. Proper etiquette should be used while using a two- way radio at all times. 6.6 Monitoring of Production, Warehouse, and QC Laboratory Areas 6.6.1 In addition to the continuous daily monitoring of production, warehouse, and QC Laboratory areas by the area supervisors/managers, weekly Gemba walks will be performed by Quality. 6.6.2 Areas assessed will be rotated each week, to ensure that all areas are covered on a routine basis. 6.6.3 Quality will notify the owners of the areas where the next Gemba walk will occur. Representatives from each of the affected areas are required to be present during the review of their areas. 6.6.4 At the completion of each Gemba walk, Quality will document in email any observations that were noted during the walk (to include any pictures or videos that were taken) and will forward to appropriate personnel for correction. 6.7 Training 6.7.1 Associate training follows procedure A-113 Training Procedure. Employee training records are maintained by the Training Department. 6.7.2 GMP Training is conducted annually. 6.7.3 Records will be maintained per SOP C-502 Record Storage, Retention, and Destruction. 6.8 GMP Exemptions [SOP Standard Operating Procedure SOP No Rev No Page Good Manufacturing Practices and Personal Hygiene A-108 17 14 of 20 6.8.1 Certain exemptions to the GMP policy may be requested at any time using Addendum 2 GMP Exemption Request. The requested exemption will be fully evaluated by HR, Quality, and Executive Management, to determine if the exemption can be granted, and what controls must be added to allow for the exemption to be made. Any new controls or conditions of approval will be documented on Addendum 2 and the completed document will be added to the employee’s HR file. 7.0 Revision History | Rev | Date | Description of Changes | CCR # | By | |-----|----------|------------------------|-------|----| | 0 | 04/12/10 | New Changed the format and title of the SOP, made the SOP more detailed | - | - | | 1 | 12/10/12 | and to be in compliance with 21 CFR part 111 Removed warehouse from 5.2.3, changed areas in section 5.2.5, 10/14/13 13-911 H. Peiser removed section 5.2.7 Removed personnel qualifications, now addressed in A-117. Added 03/13/14 14-0216 K. Burris reference to A-108-1F, Changed SOP title. 04/07/14 Added allergen controls. Revised entire SOP. 14-0306 S. Millar 04/16/14 Added section 6.1.8 and 6.2.1. Changed frocks to disposable lab coats. 14-0338 S. Millar 07/25/14 Added multiple references for gowning and hygiene. 14-0598 D. Popp w}W LIB 01/06/15 Revised SOP to include OTC. 14-1059 D. Popp Revised to reflect current practices. Added smoking regulations per 07/28/16 SQF requirements. Removed form number from Contractor 16-0581 D. Popp Agreement. Added N95 dust masks to be worn when over open product. Protective eyewear and lab coats to be worn in the lab. Warehouse and 10/03/17 Facility personnel must wear smocks/lab coats in 17-1204 J. Coyle Manufacturing/Packaging. Plant shoes are never to be worn outside. White cotton gloves for handling product in closed containers. Revised to include Lock-Out/Tag-Out Keys. Added reference to CFR and to the designated manufacturing area Removed reference to cotton gloves. Removed reference to P100 Mask, N95 Mask and added in accordance with regulations and procedures.A-105. Added reference to Masks in the Flex Packaging Area. Added reference to Masks are not required in the Flex Packaging Area as long as there is no exposed product. Added reference to embellished clothing. Added Reference to non-work related items. Added reference to jewelry that cannot be | - | - | | 10 | 12/04/18 | removed which must be covered and exceptions. Added reference to shoe cover use and exceptions. Added reference to employee contacting their Supervisor if they are ill. Added reference to cell phone use. Added reference to reporting Injury/Accident. Hands must be washed/sanitized prior to entering manufacturing area Added reference to Nail Polish and Artificial Nails. Added reference to alcohol spray of gloves. Added reference to Random Locker Inspections. Added ref. to SOP C-502. The Contractor Agreement Form has been revised and added as an addendum. | 18-0418 | S. Millar | [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 15 of 20 Added reference to Fl. Dept. of Ag. Administrative Code 5K-4.004. Added restriction of button/open pocket coats. Added reference to disposable frocks/coats discarded after use. Added reference to vaping as a form of smoking. Added a reference to medical information 11 08/12/19 19-0542 S. Millar jewelry. Added safety measure to require sign-in/out at front desk and the requirement of a badge. Added reference to visitor badge and retention of the Contractor Agreement Form. Revised to move sections to appropriate area. Added reference A-104 Emergency Preparedness, QS-105 Food Safety Plan, QS-109 Food Defense Plan, G-104 Lock out/Tag out Procedure and Florida Drug & Cosmetic Act Chapter 499(F.S). Added reference to visitors being accompanied/monitored by designated employee. Added reference to phones that are approved by management must be free of embellishments. Added reference to SOP A-104. Added reference to Hairnets/beard covers/masks and gloves not to be worn in restroom. Added reference to dedicated work shoes, approved by 12 07/01/20 | Quality and a visible orange tag or marking is placed on the shoe. | CC-20-0458 | C. Martinez Removed a statement from 6.1.2 and added 6.1.3 and 6.1.4. Added reference Ear Protection available if applicable. Ear protection must be kept clean and stored properly. Added reference to masks be worn in production rooms/areas, flex pack and warehouse areas. Requirements for masks may vary, but are required where there is open product, material or chance for any contamination Added nose as part of an exposed area. Added reference to proper etiquette when using two way radio. Removed Director from 6.3.2. Added Definitions. Changed requirements to comply with NSF/ANSI 455-2. Added hairnet assignment. Added nail embellishment, ear bud, watches, and false eye lashes not allowed. Added food and drink only consumed in designated desk area in QC Lab. Added medicine (unless approved by management) is not allowed in the manufacturing area at 13 08/10/21 | any time. Added areas that require steel toe or composite shoes are: | CC-21-0322 | C. Horelle Warehouse, Shipping/Receiving, Maintenance, and Handyman Personnel. Added sharps statement. Added current practices regarding visitor/contractor sign in/out. Added no pockets allowed above waist including items such as pens, badge clips, etc. Revised Addendum I, Contractor Agreement for Facility Access. Section 6.1.21 added different colored buckets for specific process cc-21-0409 | J. Murphy 14 11/02/21 throughout Operations. Revised Attachment I to GMP Facility Layout- Main Location, Attachment II to GMP Facility Layout- Southbrook Location, and Attachment III to GMP Requirement Chart, and Attachment IV Color 15 09/22/22 | Specification for containers. Added a statement in regards to utilize the | CC-22-0380 | C. Horelle GMP Facility Layouts and GMP Requirement Chart. Added statement in regards to coats are not to be worn when handling product or product contact materials. Revised the hairnet colors to current practice. Revised both GMP Facility Layout (Attachment 1 &2) - R&D area changed to a Zone 1, Zone 2* was changed to Zone 1, named QC Sampling Staging area, updated the layout of the QC Sampling Staging 16 12/09/22 | area. Added light blue bucket to Attachment 4. Changed misspelled | CC-23-0011 | C. Horelle word “Sequenced” to “Sequined”. Changed Southbrook to Belcher. Revised section 6.2. Changed Addendum I, Contractor agreement to add visitor. [SOP Standard Operating Procedure SOP No | Rev No Page Good Manufacturing Practices and Personal Hygiene A-108 17 16 of 20 Added requirements for Gemba walks. Updated format and wording throughout. Added additional information for dedicated shoes and shoe 17 09/23/23 | covers. Updated GMP facility layout and GMP Requirement Chart. | CC-23-0487 | K. Burris Changed location names to FL Building #1 and FL Building #2. Added additional GMP requirements. 8.0 Attachments 8.1 Attachment 1 —- GMP Facility Layout- FL Building #1 8.2 Attachment 2 - GMP Facility Layout- FL Building #2 8.3 Attachment 3 - GMP Requirement Chart 8.4 Attachment 4 — Color Specification for Containers [SOP Standard Operating Procedure SOP No Rev No Page Good Manufacturing Practices and Personal Hygiene A-108 17 of 20 Attachment 1 — GMP Facility Layout- FL Building #1 i O FL Building #1 Location- 8031 114" Ave., Largo, Florida 33773 Nutritional Labs Internal Receiving Dock Doors Shipping Bock Doors ODS HETT ANOTATA TTT ARETE EASA ETI CACTI CIP Room Gummy Line 3 & 5 Clear Tray fl Sele Tray M Dry Room et 2 é Dry Room Gummy Line 2 iaS g= a2 s¥ eened o oa no Ory Aoom a aa 5 E 8 € cat] Packaging Line (3G) tw ~~] | wash Sink Baste Pack Powder Blending Flex Pack Area Hi WiP/Storege Racks c uo gs Encapsulation Tableting Packaging Hand “vats Stak Coating | PSANADRAT REPTRNALfi eB * Unrestricted GMP Zone 1 GMP Zone 2 Visitor Entrance ena yew [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 18 of 20 Attachment 2 —- GMP Facility Layout- FL Building #2 O iY Unrestricted FL Building #2 Location- 10950 Belcher Road, Seminole, FL 33777 Nutritional GMP Zone 1 GMP Zone 2 Visitor Entrance *Exception- no safety vest are required Roveiving Crtrance C kcoD Qc Sampling Booth Zonei* [SOP Standard Operating Procedure SOP No Rev No Page Good Manufacturing Practices and Personal Hygiene A-108 17 19 of 20 Attachment 3 - GMP Requirement Chart Description | G Required | Allowed Not Required | Allowed Required Allowed Not Allowed Allowed Hairnet/ Beard nets v v v Uniforms v v no product contact hendiing Production Frocks v v v Heavy Coats v v % no product contact hardling Gloves v v v Mask v v Y within st exposed product/preduct contact materials Designated Shoes v v required: must wear shoe covers if no designstac shoes Jewelry v v ¥ except madical Jewalry- must be covered Hand Jewelry v v Y must be covered if can’t remove Face Jewelry v v Y must be covered if Ear Buds v v tan‘s 7 remove Cell Phone v v Y slowed if management epproves Artificial Nails v v Vv mustbe coverad False Eyelashes v v v Nail Polish v v Y mustbe covered Bejeweled Clothing v v v Shorts/Capris/Skirts/ v ~ unless changing te v Dresses/ Sleeveless uniform Shirts/Hats Safety Vests Y required % required required when when nacessary when necessary necessary Ear Plugs Y required required required when when necessary whan necessary necessary Safety Glasses v required Y required Y required when when necessary whan necessary necessary Food/Drink/Gum/Candy vw v ov Medicine v v unless HR Y unless HR approved epproved [SOP Standard Operating Procedure SOP No | RevNo| page Good Manufacturing Practices and Personal Hygiene A-108 17 20 of 20 Attachment 4 — Color Specification for Containers Powders, Capsules, Tablets (product) Xellow Containers Trash Only Blue Product Waste Ll Liquid (product) Orange Clean Rags Utility Use [SOP el! O Contractor/Visitor Agreement for Facility Access Nutritional Labs Contractors/Visitors must agree to comply with GMP and all specified requirements per Ion Labs, Inc. procedures as communicated by the authorized Ion Labs, Inc. personnel responsible for their supervision, including the following: As a Safety Measure, Contractors, and Visitors are required to sign-in and out at the lobby at the Main facility and Dock A at the Belcher facility. A visitor ID tag must be worn when on the property (tag is disposable and includes photo, name, date and time). Visitors must be escorted/monitored by a designated employee. The use of cameras and other recording devices is prohibited without expressed written consent. In case of an emergency, stay with your escort and evacuate the building safely. Prior to entering the production area, Contractors or Visitors are asked to wash their hands. Smoking and the use of other tobacco products are only allowed in designated areas. Food or drink is prohibited in the manufacturing and warehouse areas. Required gowning and PPE must be worn as applicable. Remove all jewelry and other unsecured objects. Jewelry such as rings, bracelets, earrings, piercings on exposed areas of the body and necklaces are not permitted in the manufacturing area. If hand jewelry cannot be removed, it must be covered by gloves at all times to protect against contamination of components, products and surfaces. Bags, Purses and Cell Phones may be stored in a secure area. Note: Frocks/Coats and PPE cannot be worn outside of the building. Any injury must be reported immediately to your escort. Contracted Company: Contract Period: (provide start and end period if possible) Address: STREET CITY ST ZIP Printed Name Signature Date Ion Labs assigned employee accepting responsibility for contractor/visitor supervision: Purpose of visit: Escort Print Name: Title: Signature: Date: [SOP GMP Exemption Form Exemption from Good Manufacturing Practices Policy I am requesting exemption from Ion Nutritional Labs Good Manufacturing Practices Policy for reasons listed below. I understand that if I have questions, at any time, regarding the GMP Policy, I will contact my immediate supervisor or Human Resources. Please note that not all requests can be accommodated. Some exemptions will come with special circumstances and additional controls. Reason for the exemption: Item being requested for exemption: Employee Printed Name: Employee Signature: Approval Status L1 Approved LC) Denied OU Approved with conditions Conditions of Exemption HR Representative Printed Name: HR Representative Signature / Date: Executive Management Printed name: Executive Management Signature / Date: Quality Representative Printed Name: Quality Representative Signature / Date: