all personnel involved in method development activities within the Analytical Method Development (AMD) department, including wet lab experimentation, protocol writing, data analysis, and reporting.

3. Responsibilities

• Analytical Scientist: Responsible for generating and maintaining experimental records accurately and in real time.
• QA Reviewer: Verifies documentation for compliance, completeness, and data integrity.
• Documentation Coordinator: Ensures indexing, archival, and retrieval of development records and electronic data.
• Department Head: Oversees overall compliance and addresses documentation-related deviations or observations.

4. Accountability

The Head of the Analytical Method Development department is accountable for enforcing proper documentation practices and ensuring training and adherence by all team members.

5. Procedure

5.1 General Principles of Good Documentation Practices (GDP)

• All entries must be legible, permanent, and accurate.
• Write entries in ink (blue or black); no pencil entries are permitted.
• Use single-line cross-outs for corrections, initial, date, and provide justification if required.
• All data must be recorded in real-time, not on scraps or post-experiment notes.
• Never leave blank spaces; use “NA” or “Not Applicable” with reason.

5.2 Document Types and Their Handling

1. Method Development Protocols: Outline experimental objectives, parameters, and evaluation criteria.
2. Raw Data Sheets: Printouts, chromatograms, analytical weights, pH, temperature logs must be numbered, signed, and dated.
3. Analyst Worksheets: Used to log each step and observation. Maintain pagination and cross-reference attachments.
4. Laboratory Notebooks: Every page should be signed by analyst and reviewer; pagination must be pre-printed or pre-numbered.
5. Electronic Data: Ensure audit trails are active. File names must follow naming conventions (e.g., AMD-MDP-001-HPLC-Inj001).

5.3 Recording Experimental Observations

1. Include:
   • Date and time of experiment
   • Analytical method number/version
   • Instrument and column ID numbers
   • Environmental conditions (for sensitive assays)
   • Batch numbers of reference standards or chemicals used
2. Observations should be descriptive and quantitative wherever possible (e.g., “solution turned turbid after 3 minutes”).

5.4 Documentation of Changes and Deviations

1. All changes to method parameters (e.g., flow rate, mobile phase composition) must be:
   • Documented in the experimental worksheet
   • Justified with scientific rationale
   • Authorized by a senior analyst or supervisor
2. Significant deviations must be recorded in the deviation log (Annexure-1) and reported to QA within 24 hours.

5.5 Review and Verification

1. QA or peer reviewers must:
   • Verify completeness of records
   • Ensure calculations are accurate and traceable
   • Check consistency with protocol and reported results
2. Use Annexure-2 checklist for systematic review of documentation practices.

5.6 Archival and Retrieval

1. All completed protocols, notebooks, and electronic data files must be indexed and archived by the Documentation Officer.
2. Maintain both physical and digital records in the central AMD repository with access logs and retrieval SOP compliance.

6. Abbreviations

• GDP: Good Documentation Practices
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• AMD: Analytical Method Development

7. Documents

1. Annexure-1: Method Development Deviation Log
2. Annexure-2: Documentation Compliance Checklist
3. Analytical Method Development Protocol Template

8. References

• WHO Annex 3 – Good Documentation Practices
• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 11 – Electronic Records and Signatures
• EU GMP Annex 11 – Computerised Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Megha Sharma	Santosh Rathi	Dr. Harshita Goyal
Designation	Analytical Scientist	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Method Development Deviation Log

Deviation ID	Description	Date	Analyst	Action Taken
DEV-382-01	Omitted solvent pH adjustment	29/05/2025	M. Sharma	Protocol updated

Annexure-2: Documentation Compliance Checklist

• Are all worksheets paginated and signed?
• Is all raw data attached and cross-referenced?
• Are corrections compliant with GDP?
• Are deviations documented and justified?

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Included new annexures and digital documentation handling	Periodic SOP Review	Dr. Harshita Goyal
20/05/2022	1.0	Initial SOP release	New Document	QA Head