integrity, traceability, compliance with cGMP regulations, and supports regulatory inspections and audits.

2. Scope

This SOP applies to all chromatographic techniques such as HPLC, GC, UPLC, and related instruments used for method development in the Analytical Method Development (AMD) laboratory. It covers electronic and printed data, including chromatograms, audit trails, result summaries, and method files.

3. Responsibilities

• Analytical Scientist: Responsible for correct data acquisition, documentation, and printouts.
• AMD Reviewer: Verifies compliance with protocols and ensures completeness before archival.
• QA Representative: Audits archival system for GMP compliance and ensures adherence to data retention timelines.
• IT Administrator (if applicable): Manages access controls and data backup on CDS (Chromatography Data System).

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that all chromatographic data is appropriately controlled, reviewed, and archived in accordance with applicable regulatory guidelines such as 21 CFR Part 11 and ALCOA+ principles.

5. Procedure

5.1 Data Acquisition and Labeling

1. Each chromatographic run must be assigned a unique sequence ID with analyst initials and date.
2. Ensure method parameters and sample sequence are saved within the CDS and backed up to the server.
3. Label each chromatogram with project code, sample ID, batch number, and analysis type.

5.2 Printout and Verification

1. Obtain printouts of chromatograms, system suitability, integration tables, and summary reports.
2. Verify printouts for legibility, correct date/time stamp, method version, and integration parameters.
3. Attach all printouts to the analytical worksheet and route for review.

5.3 Data Review and Approval

1. Reviewer cross-checks retention time, peak area, resolution, and system suitability criteria.
2. Any deviation from expected chromatographic behavior must be investigated and documented (refer SOP on OOT/OOS).
3. Upon approval, reviewer signs and dates each page of chromatographic data.

5.4 Electronic Data Control

1. Ensure all raw data files, methods, and reports are saved in the designated secured network path.
2. CDS software must have access control (username/password) and audit trail enabled.
3. Do not delete, overwrite, or rename raw data files post-acquisition.

5.5 Data Archival

1. Archived data includes:
   • Hard copies of chromatograms and supporting printouts
   • Electronic backup on secure server/CD/DVD/cloud as per policy
2. Use Annexure-1 to catalog all data sets archived for each study/project.
3. Store physical records in fireproof cabinets with restricted access.

5.6 Retention Period

1. Maintain chromatographic records for a minimum of 5 years or as per regulatory/market requirements.
2. For clinical submissions or stability programs, retention period may extend to product shelf life + 1 year.

5.7 Disposal of Archived Data

1. Upon completion of retention period, initiate controlled destruction using Annexure-2.
2. Destruction must be approved by QA and logged with date, responsible person, and method (shredding, digital wiping).

6. Abbreviations

• CDS: Chromatography Data System
• QA: Quality Assurance
• HPLC: High Performance Liquid Chromatography
• GC: Gas Chromatography
• UPLC: Ultra Performance Liquid Chromatography

7. Documents

1. Annexure-1: Chromatographic Data Archival Log
2. Annexure-2: Data Destruction Request and Approval Form

8. References

• 21 CFR Part 11 – Electronic Records and Signatures
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO Annex 5 – Guidance on Good Data and Record Management Practices
• MHRA GxP Data Integrity Guidance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Simran Kaur	Dr. Ravi Reddy	Dr. Meenal Patil
Designation	Analytical Scientist	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Chromatographic Data Archival Log

Project ID	Sample ID	Instrument ID	Sequence File	Storage Location
AMD-350	SMP-8724	HPLC-04	SEQ-HPLC-350A	Cabinet A5, Folder 2

Annexure-2: Data Destruction Request and Approval Form

Data ID	Type	Retention End Date	Destruction Method	Approved By
CHRO-2020-001	Printed	31/03/2025	Shredding	QA Manager

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Aligned with WHO GXP data integrity guidance	Annual SOP Review	Dr. Meenal Patil
01/05/2022	1.0	Initial Release	New SOP	QA Head