within the Analytical Method Development (AMD) department. This ensures data integrity, traceability, and compliance with current regulatory standards such as ALCOA+ and Good Laboratory Practices (GLP).

2. Scope

This SOP applies to all analysts, scientists, and contract personnel working in the AMD laboratory who are responsible for generating, recording, or reviewing experimental data and activities in laboratory notebooks (paper or electronic).

3. Responsibilities

• Analysts: Record all experimental work in a clear, legible, and chronological manner.
• Supervisors/Group Leaders: Review and sign completed entries and ensure timely documentation practices are followed.
• QA Personnel: Conduct periodic audits to ensure notebooks meet compliance and data integrity requirements.

4. Accountability

The Head of AMD is accountable for implementation, training, and adherence to documentation practices outlined in this SOP. QA Head is accountable for oversight and periodic review of documentation compliance.

5. Procedure

5.1 Notebook Allocation and Identification

1. Each analyst will be assigned a uniquely numbered laboratory notebook.
2. Record the following on the front cover:
   • Name of the Analyst
   • Department
   • Notebook Number
   • Start and End Date
3. Issue and return of notebooks shall be tracked by the AMD Documentation Officer using Annexure-1.

5.2 Documentation Guidelines

1. Write entries using a permanent ink pen (blue or black). Do not use pencils or erasable ink.
2. Each page must be numbered sequentially and entries must be dated.
3. Start each new experiment on a new page and provide a meaningful title.
4. Record the objective, materials, procedure, observations, calculations, and results.
5. Any graphs or printouts must be glued securely and signed across the pasted portion.

5.3 Corrections and Deviations

1. Do not use correction fluid, erasers, or overwrite data.
2. For corrections, strike through the incorrect entry with a single line, write the correct data next to it, and sign with date and initials.
3. Deviations from procedure must be recorded and justified clearly.

5.4 Signature and Review

1. Each entry must be signed and dated by the analyst upon completion.
2. Reviewer (Group Leader or Supervisor) must review and countersign within 5 working days.
3. Comments by the reviewer must be dated and documented next to the reviewed content.

5.5 Closure of Notebook

1. Upon completion, the notebook shall be closed with a summary and date of closure.
2. QA or Documentation Officer shall verify completeness before archiving.
3. Notebook status is updated in Annexure-1 record sheet.

5.6 Electronic Laboratory Notebooks (ELN)

1. If used, ELNs must be validated systems compliant with 21 CFR Part 11.
2. User access control, audit trails, and backup mechanisms must be enabled.
3. Follow same documentation principles as physical notebooks.

6. Abbreviations

• AMD: Analytical Method Development
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available
• ELN: Electronic Laboratory Notebook
• GLP: Good Laboratory Practices

7. Documents

1. Notebook Issue and Return Register – Annexure-1
2. Notebook Review Checklist – Annexure-2

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• WHO TRS 996 Annex 5 – Guidance on Good Data and Record Management Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Sneha Mehta	Rajiv Sharma	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: Notebook Issue and Return Register

Notebook No.	Issued To	Issue Date	Return Date	Remarks
AMD-LNB-0052	Sneha Mehta	01/03/2025	30/05/2025	Archived

Annexure-2: Notebook Review Checklist

Checklist Point	Status (Yes/No)	Reviewer Comments
Pages numbered and dated	Yes	Consistent
No correction fluid used	Yes	Compliant
Entries reviewed in time	Yes	Within 5 days

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Included ELN guidelines and expanded correction procedures	Data Integrity Initiative	Dr. Harshita Goyal
20/05/2022	1.0	Initial release	New SOP	QA Head