Raw Material and Finished Product Non-GMP Testing

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1.0 Purpose 
 
 This procedure defines the requirements for testing under non-GMP guidelines during raw
 material and finished product evaluation. 
 
 2.0 Scope 
 
 This procedure applies to all raw materials and finished products used or produced at Ion Labs
 Inc. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of QC and Analytical Chemists to follow this procedure.
 
 Bd It is the responsibility of QC Laboratory Management to implement this procedure and
 
 to select appropriate methods when non-GMP testing is elected. 
 
 3.3 It is the responsibility of QC Laboratory Management and/or Analytical Development
 
 Personnel to keep this procedure aligned with current practices. 
 
 3.4 It is the responsibility of R&D to determine customer testing needs for raw materials
 
 and finished products and to work with QC Laboratory Personnel to categorize the
 required tests. 
 
 4.0 Definitions 
 
 4.1 GMP — Good Manufacturing Practices 
 
 4.2 GLP — Good Laboratory Practices 
 
 
 

[SOP D-203 | Page 2 of 3]

 Standard Operating Procedure SOP No Rev 
 Raw Material and Finished Product Non-GMP Testing D-203 Page 2 of 3 
 
 4.3 QC- Quality Control 
 
 4.4 FDA-— Food and Drug Administration 
 
 4.5 USP -— United States Pharmacopeia 
 
 4.6 CFR - Code of Federal Regulations 
 
 4.7. AOAC -— Association of Analytical Communities 
 
 4.8 CofA — Certificate of Analysis 
 
 5.0 References 
 
 5.1 21 CFR 111 - Code Of Federal Regulations, Current Good Manufacturing Practice In
 
 Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements
 
 6.0 Procedure 
 
 6.1 When a test is requested by the customer or is a part of an Ion Labs internal quality
 
 metric and the test is not mandatory under FDA 21 CFR 111 guidelines, the method
 used can be performed under Non-GMP guidelines using any validated method without
 
 requiring further validation or formal verification by the lon Labs QC Laboratory.
 
 6.1.1 The preferred methods for non-GMP testing of finished products and raw
 
 materials are AOAC Methods. Other published methods may be used.
 
 6.1.2 Sufficient system suitability requirements need to be met which verify that the
 test results meet predetermined accuracy and precision requirements.
 
 6.1.3. The preferred standards are traceable analytical standards. Highly purified
 chemicals with purity on the CofA are acceptable alternatives.
 
 6.1.4 Minor deviations from the published methods or monographs are permitted with
 documentation of the deviation(s) and rationale in the Laboratory Notebook.
 
 
 

[SOP D-203 | Page 3 of 3]

 Standard Operating Procedure SOP No | Rev . 
 Raw Material and Finished Product Non-GMP Testing | -203 2 azes.of$ 
 
 6.1.5 The non-GMP test designator for GMP documentation is “D-203”.
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 01/05/16 | New | 16-0016 | N. Zhang |
| 1 | 02/04/19 | Scheduled Review: Changed GLP to Non-GMP throughout document. | 19-0119 | J. Maignan |
| 2 | 04/15/23 | Update format and logo. Added definitions. Changed CC- responsibilities section. | 23-0187 | K. Burris |