SOP for Handling Method Development Notebooks in the AMD Department
| Department | Analytical Method Development |
|---|---|
| SOP No. | SOP/AMD/038/2025 |
| Supersedes | SOP/AMD/038/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 19/05/2025 |
| Effective Date | 20/05/2025 |
| Review Date | 19/05/2026 |
1. Purpose
This SOP describes the procedures for the issuance, utilization, review, and archival of Analytical Method Development (AMD) notebooks used to record method development trials, observations, and data. The objective is to ensure consistency, traceability, and compliance with ALCOA+ principles, GMP, and data integrity requirements.
2. Scope
This SOP is applicable to all bound notebooks used by scientists and analysts in the AMD department to record experimental data, observations, instrument settings, and method development outcomes related to APIs and formulations.
3. Responsibilities
- Analytical Scientist: Records entries in a timely, legible, and compliant manner in the method notebook.
- QA: Issues, reviews, and archives completed notebooks; audits for compliance with data integrity principles.
- Department Coordinator: Maintains the issuance and return log of notebooks.
- Head – AMD: Approves the closure of notebooks and ensures training of personnel on notebook handling practices.
4. Accountability
The Head of AMD is accountable for enforcing the SOP on notebook handling and ensuring no unofficial records are used for capturing method development data.
5. Procedure
5.1 Notebook Format and Structure
- All notebooks used must be:
- Bound with numbered pages
- Free from removable sheets or post-its
- Pre-labeled with a unique Notebook ID (e.g., AMD/NB/001)
- Each notebook must include:
- Index page
- User identification page
- Issued and returned dates
5.2 Notebook Issuance
- Request new notebooks by submitting Annexure-1: Notebook Requisition Form to QA.
- QA records issuance in Annexure-2: Notebook Issuance Log and updates master list.
- The scientist signs the issuance log and becomes accountable for its use.
5.3 Recording Entries
- All entries must be:
- Made in black or blue permanent ink
- Dated and signed by the analyst
- Verified by a second person, where applicable
- Experimental design, rationale, trial conditions, and observations must be recorded real-time.
- Diagrams, chromatograms, and tables may be pasted and cross-referenced to instrument IDs.
5.4 Corrections and Blank Spaces
- Do not overwrite or use correction fluids.
- To correct an error:
- Strike through with a single line
- Initial, date, and provide justification
- Blank spaces must be ruled off with diagonal lines and annotated as “Cancelled.”
5.5 Notebook Review and Closure
- Upon completion, the analyst submits the notebook to QA for review and closure.
- QA verifies:
- Page integrity and sequence
- Signatures, dates, and correction practices
- Data completeness and consistency
- QA documents review in Annexure-3: Notebook Review Checklist.
5.6 Notebook Archival
- Closed notebooks are labeled “ARCHIVED” and stored in a secure, humidity-controlled area.
- QA updates Annexure-4: Notebook Archival Register with retrieval tracking information.
- Retention period shall be a minimum of 10 years unless regulatory requirements specify longer.
5.7 Loss or Damage of Notebook
- Report immediately to QA and Head – AMD using Annexure-5: Notebook Incident Report.
- Initiate deviation management procedure as per SOP/QMS/042/2025.
- Impact assessment to be performed on lost data and reported in closure document.
6. Abbreviations
- AMD: Analytical Method Development
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- ID: Identification
7. Documents
- Notebook Requisition Form – Annexure-1
- Notebook Issuance Log – Annexure-2
- Notebook Review Checklist – Annexure-3
- Notebook Archival Register – Annexure-4
- Notebook Incident Report – Annexure-5
8. References
- WHO TRS 1019 Annex 5 – Good Data and Record Management Practices
- ICH Q10 – Pharmaceutical Quality System
- 21 CFR Part 11 – Electronic Records; Electronic Signatures (where applicable)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Notebook Requisition Form
| Date | Requested By | Designation | Purpose | Approved By |
|---|---|---|---|---|
| 01/05/2025 | Rajesh Kumar | Analyst | Method Trials | Sunita Reddy |
Annexure-2: Notebook Issuance Log
| Notebook ID | Issued To | Issue Date | Returned Date | Status |
|---|---|---|---|---|
| AMD/NB/017 | Meenal Patil | 02/05/2025 | — | In Use |
Annexure-3: Notebook Review Checklist
| Checklist Item | Status | Reviewed By | Date |
|---|---|---|---|
| All pages used and numbered | Yes | QA Officer | 16/05/2025 |
| Corrections justified | Yes | QA Officer | 16/05/2025 |
Annexure-4: Notebook Archival Register
| Notebook ID | Location | Archived By | Date |
|---|---|---|---|
| AMD/NB/012 | Shelf A2 | QA Coordinator | 01/03/2025 |
Annexure-5: Notebook Incident Report
| Date | Notebook ID | Issue | Reported By | Action Taken |
|---|---|---|---|---|
| 05/05/2025 | AMD/NB/015 | Spilled solvent on pages | Ajay Verma | Pages scanned and preserved digitally |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Expanded annexures and introduced digital archival guideline | Internal audit findings |