validation, transfer, and routine analysis. This ensures accuracy, traceability, and regulatory compliance.

2. Scope

This SOP is applicable to all AMD personnel and QA personnel involved in the issuance, use, retrieval, and control of raw data sheets in the laboratory.

3. Responsibilities

• Analyst: Requests and uses data sheets appropriately, fills entries legibly, and submits them post-use for review.
• AMD Documentation Officer: Maintains logbooks, issues sheets with unique serial numbers, and archives used forms.
• QA Reviewer: Verifies correct usage and reviews completed raw data for integrity and completeness.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring adherence to this SOP, and for safeguarding the integrity and traceability of raw analytical data sheets throughout their lifecycle.

5. Procedure

5.1 Format and Structure of Raw Data Sheets

1. Raw data sheets must be:
   • Pre-approved by QA
   • Assigned with unique serial numbers
   • Printed on official company letterhead or preformatted templates
2. Each sheet shall include:
   • Title and purpose
   • Reference SOP or protocol number
   • Section for date, analyst name, signature, and observations

5.2 Issuance of Raw Data Sheets

1. The AMD Documentation Officer maintains an issuance register (Annexure-1).
2. Sheets are issued only upon written/email request by the analyst with approval from Section Head.
3. Details such as SOP number, project name, analyst name, and number of sheets are recorded in the issuance register.

5.3 Usage Guidelines

1. Analysts must:
   • Fill entries in indelible ink
   • Correct errors by single-line strike-through with initials and date
   • Complete all fields; “NA” should be mentioned where not applicable
2. Each page must be numbered (e.g., Page 1 of 5) and signed by the analyst at the bottom.

5.4 Post-Use Handling and Review

1. Used sheets are submitted to AMD Reviewer for review.
2. QA performs a secondary check for:
   • Legibility and completeness
   • Consistency with instrument records
   • Adherence to ALCOA+ principles
3. Reviewed sheets are archived in the project-specific folder or validation dossier.

5.5 Control and Retention

1. All issued sheets (used or unused) are returned to Documentation Officer within 15 days.
2. Obsolete or damaged sheets are cancelled by marking “VOID” across the sheet and retained for record.
3. All records must be retained for a minimum of 5 years or as per regulatory/QA policy.

6. Abbreviations

• QA: Quality Assurance
• AMD: Analytical Method Development
• SOP: Standard Operating Procedure
• ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate

7. Documents

1. Issuance Register – Annexure-1
2. Void Sheet Log – Annexure-2

8. References

• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – GMP for Finished Pharmaceuticals
• MHRA GxP Data Integrity Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Issuance Register

Issuance ID	Project	Analyst	No. of Sheets	Issue Date	Return Date	Remarks
IS/AMD/394/01	AMV-25	Neha Sinha	10	01/06/2025	10/06/2025	All returned

Annexure-2: Void Sheet Log

Sheet ID	Void Date	Reason	Cancelled By
RS/AMD/394/07	02/06/2025	Damaged during handling	QA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added Annexure formats and clarified issuance conditions	Annual SOP Review	Dr. Harshita Goyal
10/08/2022	1.0	Initial issue	New procedure implementation	QA Head