Record Storage, Retention, And Destruction REV 6

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1.0 Purpose 
 
 The purpose of this procedure is to define the requirements for the storage of documents and
 files related to the manufacture, production, packaging, labeling, holding, and distribution of
 dietary supplements, pet products, and OTC drug products. This procedure details the types of
 
 records, responsible departments, locations for storage, minimum retention times, destruction
 methods, and conditions for storage. 
 
 2.0 Scope 
 
 This procedure applies to all quality, regulatory and related records/documents retained by Ion
 Labs, Inc. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of Quality to establish the system for identification, retention,
 retrieval, access, destruction, and control of quality records/documents.
 
 3.2 It is the responsibility of DC to provide adequate and organized storage of quality
 records and documents associated with the manufacture, production, packaging,
 labeling, holding, and distribution of all products, and to maintain these documents for
 
 the retention period outlined in this procedure. 
 
 3.3 It is the responsibility of all involved departments to follow this procedure.
 
 4.0 Definitions 
 
 4.1 Quality Record — A record that provides evidence of the conformity, implementation,
 and effective operation of the quality system. 
 
 4.2 DC — Document Control 
 
 4.3 Electronic Record — Information captured through electronic means 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev haint ot 
 Record Storage, Retention, and Destruction C502 6 
 
 5.0 References 
 
 5.1 21 CFR Part 11 
 
 5.2. [$0 17025:2017 
 
 6.0 Procedure 
 
 6.1 Quality records/documents will be gathered and stored by the responsible departments
 
 as specified in Attachment 1 to provide documented evidence that quality processes
 have taken place and that products have been manufactured and distributed to
 applicable specifications. The records will be filed in a way that provides for expedient
 retrieval. 
 
 6.2 Transfer of records between Belcher Warehouse and Main buildings will be conducted
 
 to ensure that the integrity of the documents is maintained. 
 
 6.2.1 Batch records will be transferred while secured in Batch Record Binders.
 
 6.2.2 Individual files and records that are not batch records that are secured in binders
 will be transferred between buildings in a document transfer container which will
 be securely closed during transit. 
 
 6.3. .Records to be retained may be defined in procedures and work instructions.
 
 6.3.1 Ata minimum, records will be retained for one year past the shelf life date, if
 
 shelf life dating is used, or two years beyond the date of distribution of the last
 batch of product associated with those respective records. 
 
 6.3.2 Employment/Training Records will be kept for the duration of employment plus
 an additional 2 years. 
 
 6.3.3 Medical exposure documents/records will be kept for the duration of
 employment plus an additional 30 years. 
 
 6.3.4 Laboratory records will be kept for the required retention period determined by
 customer requirements, accreditation body requirements, regulatory
 requirements, and decisions by Management. The longest period required is
 used. If record retention periods change to a longer retention period due to new
 requirements, the new retention length is noted. The retention period for
 laboratory records is currently set at 6 years. 
 
 
 

[SOP 

 Standard Operating Procedure SOPNo | Rev 
 C-502 6 Page 3 of 5 
 Record Storage, Retention, and Destruction 
 
 6.3.4.1 Laboratory records associated with customer orders are made available
 to customers and/or regulatory authorities as required.
 
 6.3.5 Financial records supporting the purchase and procurement of raw materials and
 packaging items used in production should be retained for 6 years.
 
 6.3.6 Financial tax documents must be kept for a minimum of 4 years or as Federal,
 
 State, or Local regulations dictate. 
 
 6.3.7 Depreciable asset documents must be kept for the life of depreciation plus an
 additional 3 years. 
 
 6.3.8 Federal, State, or Local regulations may apply by department/document
 requirements. 
 
 6.3.9 Equipment qualification/validation records are retained for the life of the
 equipment. 
 
 6.4 Records will be archived on site in the DC department or respective departments as
 designated by management. 
 
 6.5 Record Storage 
 
 6.5.1 Management will ensure all quality records and documents associated with the
 manufacture, production, packaging, labeling, holding, and distribution of all
 products are legible, stored, and retained to be readily available, in facilities that
 
 provide a suitable environment to prevent damage or deterioration and to
 prevent loss. 
 
 6.5.2 Paper documents will be stored in a clean, dry area, away from direct sunlight.
 Clear and legible reference shall be made on the quality record as to which
 process or product it refers to. 
 
 6.5.3 Electronic records are backed up at regular intervals. Nightly on and offsite
 
 backups are performed. Onsite backups are retrievable via a local drive. The
 system is continually monitored to ensure recovery and may be audited as part
 of our internal audit process to ensure effectiveness. 
 
 6.5.4 Records deemed confidential will be reviewed for proprietary information or
 trade secrets and will be marked as “Confidential” when appropriate.
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 C-502 Page 4 of 5 
 Record Storage, Retention, and Destruction 
 
 6.5.5 Records will be retained per established minimum record retention schedules.
 At the end of the retention time, record disposition will be handled by
 management and, if applicable, destruction handled by a reputable document
 destruction service, who may provide a certificate of destruction upon
 shredding. 
 
 6.6 The record/document storage chart (Attachment 1) lists the quality records, storage
 locations, and the minimum retention times for records for each responsible department.
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/21/14 | _ New 07/23/14 Added section for electronic document retention and backup 14-0558 S. Millar | 14-0407 | S. Millar |
| 2 | 02/06/15 | Generalized for all products | 14-1065 | D. Popp |
| 3 | 07/25/17 | Added requirements for equipment documentation. 4 05/021 aStcthaecdhumleendt r1e.v Aiedwd: CrFeRm ovreefde rVeenlioocei.t y % as external IT suprppo rt. Up°d ate ssesliciella haaheieel;a | 17-0763 | S. Millar |
| 5 | 10/15/21 | Updated to include ISO 17025:2017 requirements CC- | 21-0413 | J. Sassman |
| 6 | 04/28/25 | Added transfer of records between buildings CC- | 25-0201 | K. Markovic |

 8.0 Attachments 
 
 8.1 Attachment 1 — Records/Document Storage Chart 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 C-502 6 Page 5 of 5 
 Record Storage, Retention, and Destruction 
 
 Attachment 1 — Records/Document Storage Chart 
 
 RESPONSIBLE 
 RECORD TYPE DEPARTMENT LOCATION RETT ENTION P ERIOOD 
 Document Change 
 Records/Procedure/ Quality Document Control 6 yrs. 
 Customer Complaints/ 
 Adverse Event Files/ Non- 
 Conforming Documentation/ Quality Document Control 6 yrs. 
 Deviation/CAPA 
 Product Review/Batch . 
 Records Quality Document Control 6 yrs. 
 External/Internal Audits Quality Document Control 6 yrs. 
 Vendor Review/Assessment Purchasing/Quality Document Control 6 yrs. 
 Employee/Training Quality/HR Document Control/HR pasa ee pee 
 
 Purchase Orders Accounting Accounting Office 6 yrs. 
 Recalls Quality/RA Document Control 6 yrs. 
 Corrective Actions Quality/RA Document Control 6 yrs. 
 Management Review! juality Quality/RA Document Control 6 yrs 
 Analysis/Plan y bi YES. 
 Specifications R&D/Production Control Document Control 6 yrs. 
 
 Lab Testing/Records/Logs/ 
 Calibration QC Laboratory Document Control 6 yrs. 
 Organizational Charts HR HR 6 yrs. 
 Vendor/Subcontractor Purchasing/Accounting Purchasing/Accounting 6 vrs 
 Supplied Records/Reports Quality/Purchasing Document Control YES. 
 Shipping/Receiving Records Accounting Accounting 6 yrs. 
 
 Sales/Order Entry Accounting Accounting 6 yrs. 
 
 Labeling/Graphics/ 
 Packaging Associated Quality/Document Control Document Control 6 yrs. 
 Records 
 ; Duration of Employment 
 pmlc HR HR plus 30 years per OSHA
 ocuments ; 
 Requirements 
 Facility Records ; , oy 
 Equipment Matitensnce Operations Maintenance/Facility 6 yrs. 
 Equipment ; ; 
 Qualification/Validation Operations Document Control ciate eene pins-6 
 Records .