New Product Documentation Requirements

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1.0 Purpose 
 
 The purpose of this procedure is to define responsibilities and documentation requirements for
 
 new and/ or revisions to all finished products manufactured at Ion Labs, Inc.
 
 2.0 Scope 
 
 This procedure applies to finished products manufactured at Ion Labs, Inc.
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of the QC Laboratory to test all finished products as defined in
 the Product Profile. The QC Laboratory is also responsible for providing certain
 
 information required to create a product profile. 
 
 3.2 It is the responsibility of R&D to create product profiles, FPTDs, and FPTTs.
 
 3.3 ~—‘It is the responsibility of Quality Management to review and approve product profiles,
 FPTDs, FPTTs, and COAs. 
 
 3.4 ‘It is the responsibility of the QC Laboratory to input and verify the results on the
 Ingredient Addition Verification Specification and Results Form (refer to SOP D-403
 
 Calculations for Ingredient Addition Verification Specification and Results Form for
 
 Finished Products). 
 
 3.5. It is the responsibility of Sales to provide customer specific requested information
 
 required for customer’s COA. 
 
 3.6 It is the responsibility of Quality to create a customer’s COA. 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 D-401 12 | Page 2 of 10 
 New Product Documentation Requirements 
 
 3.1 It is the responsibility of DC to issue all Ingredient Addition Verification Specification
 
 and Results forms. DC is also responsible for maintaining approved product profiles,
 FPTDs, and FPTTs. 
 
 4.0 Definitions 
 
 4.1 Product Profile — Establishes the product formula and all in-process, finished product,
 and stability specifications which ensures the identity, purity, strength, and composition
 
 of the finished product 
 
 4.2 FPTD — Finished Product Test Details; document which provides detailed instructions
 
 for the preparation of standard and sample solutions for the required analytical tests and
 the assay calculation. 
 
 4.3 FPTT — Finished Product Test Ticket; an internal COA that contains the finished
 product specifications derived from the product profile, used to record finished product
 
 test results 
 
 4.4 Identity — A specific unique characteristic of a finished product; a positive match
 between an established/standardized characteristic and a tested finished product
 
 attribute 
 
 4.5 Purity — Absence of impurities and contamination 
 
 4.6 Strength — Quantity of an identified ingredient 
 
 4.7 Composition — An evaluation to confirm the stated constituent(s) of any raw material
 
 or finished product, i.e. pH, density, moisture, FTIR. 
 
 4.8 FTIR — Fourier Transform Infra-Red Spectroscopy Analysis 
 
 4.9 Marker Chemical — A chemical constituent in a finished product that has been
 identified for analytical testing 
 
 4.10 TAPC — Total Aerobic Plate Count 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
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 D-401 12 
 New Product Documentation Requirements 
 4.11 OOS — Out of Specification 
 
 4.12 OOT — Out of Trend 
 
 4.13 IAV — Ingredient Addition Verification Specification and Results Form; document
 
 which contains quantitative ingredient specifications associated with label claim
 support 
 
 4.14 COA — Certificate of Analysis 
 
 4.15 Quality — Comprises all Quality Departments 
 
 4.16 QA — Quality Assurance 
 
 4.17 QC — Quality Control 
 
 4.18 DC — Document Control 
 
 4.19 R&D — Research and Development 
 
 4.20 MBR — Master Batch Record 
 
 4.21 BPR — Batch Production Record 
 
 4.22 SCCP — Scientific Committee of Consumer Products 
 
 5.0 References 
 
 ie| D-403, SOP, Calculations for Ingredient Addition Verification and Results Form for
 
 Finished Product 
 
 D2 C-601, SOP, New Product Approval Process 
 
 5,3 D-401-F1-XXXXXXXX, Form, Finished Product Test Details 
 
 5.4 D-401-F2-XXXXXXXX, Form, Finished Product Test Ticket 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 D-401 12 | Page 4 of 10 
 New Product Documentation Requirements 
 
 5.5 USP <2023>, Monograph, Microbial Attributes of Nonsterile Nutritional and Dietary
 
 Supplements 
 
 5.6 NSF/ASNI 173, Standards, Dietary Supplements 
 
 5.7 USP <1111>, Pharmacopeial Monograph, Microbiological Examination of Nonsterile
 Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for
 
 Pharmaceutical Use 
 
 5.8 D-902, SOP, Establishment of Specifications 
 
 5.9 D-105, SOP, Out of Specification/Out of Trend Investigation 
 
 5.10 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.11 C-601, SOP, New Product Approval Process 
 
 5.12 C-601-F1, Form, New Product Approval Form 
 
 5.13 D-715, SOP, Microbial Limit Testing using the 3MTM PetrifilmTM System
 
 5.14 D-715.0, SOP, Microbial Limit Testing using Agar Plates 
 
 6.0 Procedure 
 
 6.1 A sales order is received for a new product prior to the manufacture of the first
 production batch. Quality must assess and establish that the new product can be
 
 manufactured and tested without issues. The supportive rationale will be documented in
 a new product approval report and attached to Form C-601-F1 New Product Approval
 
 Form (refer to SOP C-601 New Product Approval Process). 
 
 6.2 R&D will create a product profile for the new approved product based on the
 information provided in the new product approval report. 
 
 6.2.1 The product profile will define the finished product specifications, including the
 specifications required to support the label claim, support stability and to
 
 
 

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 Standard Operating Procedure SOP No | Rev ee 
 New Product Documentation Requirements D-401 | 12 age SO 
 
 determine if there are any test exemptions, and define a reduced testing program
 
 if applicable. 
 
 6.2.2 All finished product specifications are selected to encompass the identity, purity,
 
 strength, and composition of the final product. Additional performance related
 specifications, although not mandatory for each product, may be included in the
 
 finished product specifications. In addition, the appropriate stability tests are
 also specified. 
 
 6.3. R&D will obtain templates from DC and complete the required fields for Form D-401-
 
 F2-XXXXXXXX (reference attachment 1) and Form D-401-Fl1-XXXXXKXXX 
 (reference attachment 2). 
 
 Note: The XXXXXXXX represents the unique formulation number given to each
 formula. 
 
 6.4 All required finished product tests for which there are scientifically valid test methods
 will be performed in-house or by a third party laboratory. The testing criteria with
 
 specifications will be outlined in the product profile. The product specific test detail
 form(s) will provide instructions for each analytical method. When necessary, the
 
 product profile will specify the rationale for test exemptions when there is no
 
 scientifically valid method for testing an analyte in the finished product matrix and
 identifies appropriate controls and other tests to justify this approach. A reduced testing
 
 program may also be defined in the test exemption section when applicable.
 
 6.5. Purity specifications and testing are associated with microbial contaminants, are
 
 dependent upon the finished product type, and are derived from recognized standard
 guidelines. For dietary and pet supplements USP <2023> and NSF/ANSI 173 guidance
 
 is used to define specifications. For cosmetics SCCP guidance is used to define
 
 specifications. For OTC pharmaceuticals USP <1111> guidance is used to define
 specifications. Minimum purity testing for dietary and animal companion animal
 
 supplements includes TAPC, E. coli, Salmonella and Yeast / Mold and the methods and
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev ace 
 New Product Documentation Requirements D-401 | 12 age ore 
 
 specifications are defined in SOP D-715 Microbial Limit Testing using the 3MTM
 
 PetrifilmTM System. Specifications for cosmetics and pharmaceuticals are defined in
 SOP D-715.0 Microbial Limit Testing using Agar Plates. 
 
 6.6 SOP D-902, Establishment of Specifications, should be referenced and followed for
 specification creation and defining testing requirements. 
 
 6.7 DC will generate an IAV that will include the following information:
 
 6.7.1 Ingredient Name 
 
 6.7.2 Label Claim 
 
 6.7.3 Specifications 
 
 6.7.4 Results & Calculated By/Date 
 
 6.7.5 Signature/Date of DC, R&D, and Quality approvals when the form is issued and
 
 completed 
 
 6.8 Once R&D completes the product profile, FPTD, and FPTT, they are submitted for
 
 interdepartmental review and approval. 
 
 6.9 Once approved, the IAV, product profile, FPTD, and FPTT will become part of the
 MBR. 
 
 6.10 Once a batch is issued, a copy of the FPTT and product specific test details forms will
 be submitted to the QC Laboratory. The QC Laboratory will perform the specified
 
 testing in accordance with the specified method and document the test results on the
 FPTT and all associated testing and results in the QC laboratory notebooks.
 
 6.11 The completed JAV, completed FPTT (with reference to any laboratory notebook
 
 containing the testing performed), a completed customer COA, and any OOS/OOT
 investigations are collected by Quality and included in the executed BPR.
 
 

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 Standard Operating Procedure SOP No Rev 
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 New Product Documentation Requirements D-401 12 
 
 6.12 All documents will be maintained as outlined in SOP C-502 Record Storage, Retention,
 
 and Destruction. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 07/23/10 | New “ : | - | - |
| 1 | 06/10/11 | Made SOP more detailed, added form ” - | - | - |
| 2 | 08/08/11 | Made some minor changes - - 3 01/9/12 Added section 5.2 - - Made SOP more detailed. Made some clarifications, made changes | - | - |
| 4 | 07/18/12 | ae - - to table for microbial limits. Added section 3.14, added in section 4.3 ”...to enter results on Ingredient Addition Verification Specification and Results Form”, added in section 4.4 ”...issue Ingredient Addition Verification Specification and Results Form, added in section 5.5 “...testing to | - | - |
| 5 | 09/07/12 | support the label claims...and (2) the verification of ingredient _ _ addition.”, added section 5.6, added in section 5.8 “...the Ingredient Addition Verification Specification and Results Form...”, added in section 5.14 ”...completed Ingredient Addition Verification Specification and Results Form...”; changes in Form D-401-F1, D- 401-F2, D-401-F3 | - | - |
| 6 | 12/31/12 | Added ? in table 5.5.1 - - Improved clarity, removed pet products, medical food, and cosmetics, added definitions, added responsibility for product 5 I ven profile, clarified and updated instructions and responsibilities, ee Pe removed tables and generic forms | - | - |
| 8 | 04/01/16 | Biennial review: updated SOP format. | 16-0206 | B. Johns |
| 9 | 11/10/16 | Addition of OTC Pharmaceutical processes | 16-1003 | B. Johns |
| 10 | 06/24/19 | Removed reference to obsolete documents. Updated responsibilities. | 19-0402 | K. Burris |
| 7 | 11/20/19 | 3 year review. Changed title to reflect SOP contents. Minor clarifications in document. | 19-0884 | + Soeeven |
| 12 | 02/00/03 | Addceda finnisthedo pr.odu ct test details. Updated lo5g o and format. CC- | 23-0064 | K. Burri,s |

 

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 Standard Operating Procedure SOP No Rev 
 Page 8 of 10 
 New Product Documentation Requirements D-401 12 
 
 8.0 Attachments 
 
 8.1 Attachment 1 — Example of FPTT Template (Form D-401-F2-XXXXXXXX) 
 
 8.2 Attachment 2 — Example of FPTD Template (Form D-401-F1-XXXXXXXX) 
 
 

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 Standard Operating Procedure SOP No | Rev 
 New Product Documentation Requirements D-401 | 12 | Page? of 10 
 
 ATTACHMENT 1 - EXAMPLE OF FPTT TEMPLATE (FORM D-401-F2-XXXXXXXX) 
 
 This is an example only. Actual test requirements will change based on the product the document applies to.
 
 Product: Product Name Batchmaster Revision X 
 Formulation #: XXXXXXXX Batch #: 
 Category: Dietary Supplement/Cosmetic/Companion Animal Supplement 
 
 Dosage Form: Tablet/Capsule/P owder/Liquid/Lotion/Cream 
 Shelf Life: Manufacturing Date or X Year Best By Date/Expiration Date 
 
 } enC usu SyRsss See st Eca ct w a r eh R e n nn e e sO p no nO in o espPe aleeyzre e i wb P deorressessop
 
 Organoleptic — Appearance D-722 
 NLT 0.90 correlation when compared to 
 FTIR D-823 the raw material blend 
 
 a 
 REE 
 = 
 fu/g 
 Total Yeast & Mold D-715 NMT 1,000 cfu/g 
 E. coli D-715 Negative 
 Salmonella D-715 Negative 
 
 OSE by 
 TYIAERTY : 
 
 Ingredient Name 
 
 COMPOSITION 
 
 Weight Variation D-712 Conforms to USP <2091> 
 
 Disintegration D-703 NMT 30 minutes 
 
 QC Reviewed By/ Date 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 New Product Documentation Requirements D-401 | 12 | Page 10 of 10 
 
 ATTACHMENT 2 - EXAMPLE OF FPTD TEMPLATE (FORM D-401-F1-XXXXXXXX) 
 
 This is an example only. Actual test requirements will change based on the product the document applies to.
 
 Product: Product Name 
 Formula: XAXXXXXXX 
 
 Test: Elemental Impurities 
 
 1.0 Summary 
 
1.1 he following details have been verified as optimal for the Elemental Impurities of Product

 Name. Any detail listed below supersedes the testing instructions provided in D-777.
 
 Reference Elemental Impurities Validation Report 
 
 Grind in a mortar and pestle to obtain a homogeneous powder. Transfer 0.25
 Sample Amount g to a digestion vessel. Record the weight of sample added to the vessel.
 5 mL nitric acid 
 Digeestioyn nRee e t 1 mL hydrochloric acid 
 
 Digestion Wait Time Wait at least 5 min after adding reagents before starting digestion
 
 Ramp (min) Temp (°C) Hold (min) 
 Digestion Temperature Program ° » ° 
 5 120 5 
 5 180 10 
 
 Stock Sample Volume 50 mL 
 EI Dilution 5.0 mL of Stock Sample / 15 mL 
 
 2.0 Calculation 
 
 Max Daily Dose G® | 
 ug J aero da 1000g 
 as Tse cx Dilution Factor (mL) x Samp tS x ke 
 
 R, = Instrument response for target element in the Sample Preparation 
 
 Rs = Slope of the calibration curve (mL/ng) 
 Max Daily Dose = 0.00637268 kg/day (4 tablets)