Laboratory Raw Data Definition and Management

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1.0 Purpose 
 The purpose of this SOP is to describe how raw data is defined and maintained in the QC
 Laboratory. 
 2.0 Scope 
 This procedure applies to all GMP testing performed at Ion Labs for the release of any raw
 material, finished product or stability batches. 
 3.0 Responsibility 
 
 3.1 ‘It is the responsibility of QC Laboratory Management to ensure all raw data is stored
 and maintained according to the standards depicted in this SOP. 
 
 3.2 It is the responsibility of IT to secure and archive any electronic data at regular intervals
 
 4.0 Definitions 
 
 4.1 Raw Data —any laboratory worksheets, records, memorandum, notes that are the result
 of original observations and activities and are necessary for the reconstruction and
 evaluation of the report of that study. 
 
 4.2 RM -— Raw Material 
 
 4.3, CofA — Certificate of Analysis 
 
 4.4 DC -— Document Control 
 
 4.5 QC — Quality Control 
 
 4.6 SOP -— Standard Operating Procedure 
 
 5.0 References 
 
 5.1 D-901, SOP, Raw Material Life Cycle 
 
 5 C-502, SOP, Record Storage, Retention and Destruction 
 
 5.3. D-101, SOP, Laboratory Housekeeping 
 
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[SOP D-114 | Page 2 of 2]

 Standard Operating Procedure S i OP G No Re 1 v Page 2 of 2
 Raw Data Definition and Management 
 
 6.0 Raw Data Definition and Archival of Raw Data 
 
 6.1 Raw data generated for the release of finished product will be turned into DC with the
 FPTT (Finished Product Test Ticket) and will be archived with the batch record for that
 lot. 
 
 6.2 Raw data generated for stability testing will be archived with each individual stability
 study. 
 
 6.3 Raw data generated for the release of raw materials will be turned into DC, scanned
 electronically and stored on the network. 
 
 6.4 Raw data created from original observations documented in a laboratory notebook will
 be archived with the notebook in DC. 
 
 6.5 Laboratory data will be archived for a period of time as defined in SOP C-502, Record
 Storage, Retention, and Destruction. 
 
 6.6 Electronic data should also be preserved in accordance with the written documentation
 associated with the raw material, finished product or stability time point being tested.
 
 7.0 Protection of Raw Data and Archived Raw Data 
 
 7.1 Archived raw data should be stored in a location with controlled access to prevent the
 loss and/or manipulation of data. 
 
 m: Audit trails will be regularly reviewed for completeness, unreported data and any
 unexplained data deletion. 
 
 7.3 Electronic data should be archived at regular intervals. 
 
 8.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 03/22/18 | New. N/A J. Maignan | - | - |
| 1 | 06/02/21 | Clarified raw data in the laboratory CC- | 21-0216 | J. Sassman |