(GDP) during Analytical Method Development (AMD).

2. Scope

This SOP applies to all analytical calculations and worksheets generated during the development, optimization, verification, and validation of analytical methods in the AMD department.

3. Responsibilities

• Analyst: Accurately documents calculations and raw data on pre-approved formats.
• Reviewer: Verifies all entries and calculations for correctness and compliance.
• QA Personnel: Audits documentation for adherence to GDP and internal SOPs.

4. Accountability

The Head of AMD is accountable for the integrity, review, and archival of all analytical worksheets and calculations maintained under this SOP.

5. Procedure

5.1 Preparation of Analytical Worksheets

1. Use only controlled and numbered worksheets issued by the QA department (refer Annexure-1).
2. Enter the study ID, method number, analyst name, and date at the top of the sheet.
3. Fill in test conditions, sample details, instrument ID, and analysis date.

5.2 Documentation of Raw Data

1. Record all raw data (e.g., weights, volumes, instrument readings) in blue/black indelible ink.
2. Do not overwrite; strike through incorrect entries with a single line, write correct data nearby, and initial/date the correction.
3. Attach printouts (chromatograms, spectra, etc.) with analyst signature and date on each page.

5.3 Calculations and Formula Usage

1. Use approved formulae specified in the test method.
2. Show all steps of calculations including units (e.g., mg/mL, %, ppm).
3. Include dilution factors, purity corrections, and standardization values where applicable.
4. Round off values as per SOP on significant figures (refer SOP/AMD/212/2025).

5.4 Review and Cross-Verification

1. Second analyst or reviewer must cross-check 100% of calculations.
2. Reviewer to initial and date the reviewed pages after verification.
3. Any discrepancy must be investigated and documented with appropriate justification.

5.5 Archival of Worksheets

1. After QA review, compile the complete set of worksheets and associated data in a labeled folder.
2. Archive as per document control SOP (SOP/QA/001/2025) in the AMD record room.
3. Retain all documentation for a minimum period of five years or as per regulatory requirement.

6. Abbreviations

• AMD: Analytical Method Development
• GDP: Good Documentation Practices
• QA: Quality Assurance
• ID: Identification

7. Documents

1. Controlled Worksheet Template – Annexure-1
2. Calculation Formula Sheet – Annexure-2
3. Reviewer Checklist – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO TRS 986 Annex 3 – GMP for Pharmaceuticals
• FDA 21 CFR Part 211 – cGMP Requirements
• SOP/AMD/212/2025 – Guidelines on Rounding and Significant Figures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Shruti Sharma	Priya Nair	Dr. Harshita Goyal
Designation	Analyst – AMD	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Controlled Worksheet Template

Includes fields for test ID, method title, equipment ID, sample ID, dilution factors, raw data, and calculation steps.

Annexure-2: Calculation Formula Sheet

Calculation	Formula	Example
Assay	(Sample Area / Std Area) × Std Potency × Dilution Factor	(1200 / 1250) × 99.8 × 2 = 191.52

Annexure-3: Reviewer Checklist

• Worksheet signed and dated by analyst
• All calculations verified
• Corrections compliant with GDP
• Attached chromatograms, spectra, instrument logs

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Inclusion of controlled worksheet format and verification checklist	Annual SOP Review	Dr. Harshita Goyal
20/07/2022	1.0	Initial Release	New SOP	QA Head