are compliant with ICH Q2(R1), WHO, and GMP requirements.

2. Scope

This SOP applies to all analytical methods for APIs, finished products, raw materials, excipients, and cleaning procedures developed and validated in the AMD department requiring a validation protocol before method execution.

3. Responsibilities

• Analytical Scientist: Drafts the validation protocol with all necessary details.
• Group Leader: Reviews and finalizes the protocol before submission to QA.
• QA Executive: Verifies compliance with validation and documentation standards.
• Department Head: Approves the final version of the protocol for execution.

4. Accountability

The Head of Analytical Method Development is accountable for the accuracy, compliance, and timely approval of all validation protocols prior to execution.

5. Procedure

5.1 Structure of the Validation Protocol

1. The validation protocol should include the following sections:
   • Title Page (Method name, validation number, product name)
   • Table of Contents
   • Objective and Scope
   • Responsibility Matrix
   • Test Parameters (e.g., specificity, linearity, accuracy, precision, robustness, LOD, LOQ)
   • Acceptance Criteria
   • Materials and Instrumentation
   • Analytical Procedure (step-by-step method summary)
   • Data Evaluation and Reporting Requirements
   • Reference Documents
   • Annexures and Templates

5.2 Preparation Process

1. Download the latest validation protocol template (Annexure-1).
2. Insert method-specific information and define the validation approach (full, partial, verification).
3. Specify:
   • Number of batches or samples
   • Concentration range for linearity
   • Recovery levels for accuracy
   • Replicates for precision
   • Conditions for robustness

5.3 Review and Approval

1. Submit the draft to the Group Leader for internal review.
2. Forward the reviewed protocol to QA for compliance check.
3. Obtain final approval from the Department Head.
4. Store signed and approved protocol in the AMD validation archive before execution begins.

5.4 Deviation and Amendment

1. Any changes post-approval shall be documented as a protocol amendment (Annexure-3).
2. Deviations during validation must be recorded and justified in the final report with cross-reference to this protocol.

6. Abbreviations

• SOP: Standard Operating Procedure
• LOD: Limit of Detection
• LOQ: Limit of Quantification
• QA: Quality Assurance
• AMD: Analytical Method Development

7. Documents

1. Validation Protocol Template – Annexure-1
2. Parameter Table Format – Annexure-2
3. Protocol Amendment Log – Annexure-3

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• WHO Technical Report Series 996
• GMP Guidelines – Schedule M (India)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Nisha Rawat	Anuj Kulkarni	Sunita Reddy
Designation	Analyst	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Validation Protocol Template

Document Code: AMD/VAL/PROT/TEMP/01

Annexure-2: Parameter Table Format

Parameter	No. of Replicates	Acceptance Criteria
Precision	6	RSD ≤ 2.0%
Accuracy	3 levels (80%, 100%, 120%)	95–105% recovery
Linearity	5 concentrations	r² ≥ 0.990

Annexure-3: Protocol Amendment Log

Amendment No.	Date	Description	Reason	Approved By
001	20/05/2025	Added second analyst for precision	QA recommendation	Anuj Kulkarni

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Revised structure to align with ICH Q14 format	Annual SOP Review	Sunita Reddy
06/04/2022	1.0	Initial Release	New SOP	QA Head