review, and archiving of raw analytical data generated during method development activities. It ensures traceability, transparency, and data integrity in compliance with ALCOA+ principles, GMP, and regulatory standards.

2. Scope

This SOP applies to all personnel involved in generating or reviewing raw analytical data within the Analytical Method Development (AMD) laboratory, including internal staff and contract resources. It covers both manually recorded and electronically generated data.

3. Responsibilities

• Analysts: Record all raw data promptly, clearly, and accurately during experimental work. Submit raw data for review without delay.
• Supervisors: Review and approve raw data, verify compliance with SOPs and protocols, and ensure data completeness.
• QA Personnel: Periodically audit raw data handling processes and provide compliance feedback to the AMD head.

4. Accountability

The Head of the AMD department is accountable for ensuring that raw data handling and documentation procedures are implemented consistently and effectively throughout the laboratory. The QA department is accountable for oversight and compliance monitoring.

5. Procedure

5.1 Definition of Raw Data

1. Raw data includes original records and documentation resulting from analytical testing, including:
   • Instrument printouts
   • Chromatograms
   • Spectra
   • Balance printouts
   • Calculation sheets
   • Lab notebook entries

5.2 Recording of Raw Data

1. All raw data must be recorded at the time of activity using indelible ink or in validated electronic systems.
2. Each data entry must include the date, analyst’s initials, and instrument/equipment identification.
3. Manual calculations must be legibly written and verified by a second individual.

5.3 Handling Electronic Raw Data

1. Ensure data is saved in the designated secured server folder with appropriate naming conventions.
2. Audit trails must remain enabled in all computerized systems used for data acquisition.
3. No overwriting of data is permitted; any corrections must be documented separately with justification and approval.

5.4 Corrections and Annotations

1. If a mistake is identified:
   • Strike through with a single line, retain the original data
   • Write corrected data nearby with initials, date, and justification
2. Electronic data corrections must follow the same logic with audit trail justification.

5.5 Review and Verification

1. Supervisors must review raw data within 5 working days of its generation.
2. Review includes:
   • Completeness of data sets
   • Legibility of entries
   • Verification of calculations
   • Assessment of any deviations or unexpected observations

5.6 Archival of Raw Data

1. Upon review, raw data must be signed, dated, and submitted to the Documentation Officer for archival.
2. Data shall be stored in fire-proof cabinets (physical) or secure validated servers (electronic).
3. Maintain an index of raw data with document number, analyst name, and storage location (Annexure-1).

5.7 Data Integrity Monitoring

1. Periodic QA audits shall focus on:
   • Completeness of raw data
   • Legibility and attribution
   • Compliance with ALCOA+ principles

6. Abbreviations

• AMD: Analytical Method Development
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available
• QA: Quality Assurance

7. Documents

1. Raw Data Index Log – Annexure-1
2. Raw Data Checklist – Annexure-2

8. References

• 21 CFR Part 11 – Electronic Records and Electronic Signatures
• ICH Q9 – Quality Risk Management
• WHO TRS 996 Annex 5 – Good Data Management Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Vaibhav Jaiswal	Neha Sinha	Dr. Harshita Goyal
Designation	AMD Analyst	QA Reviewer	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Raw Data Index Log

Data ID	Test Name	Analyst	Date	Storage Location
RD-397-01	Assay Method Development	Vaibhav Jaiswal	24/05/2025	Server/AMD/2025/Assay

Annexure-2: Raw Data Review Checklist

Checklist Item	Status	Reviewer Remarks
All pages signed and dated	Yes	Compliant
Audit trail intact for electronic data	Yes	No unauthorized changes
Calculations verified	Yes	Cross-checked

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Incorporated detailed guidance for electronic data handling	Regulatory alignment	Dr. Harshita Goyal
10/05/2022	1.0	Initial issue	New SOP	QA Head