their intended purpose with respect to accuracy, precision, specificity, and other performance attributes aligned with ICH Q8 and Q14 expectations.

2. Scope

This SOP applies to all analytical development scientists, team leads, and quality reviewers involved in method design, optimization, validation, and technology transfer in the Analytical Method Development (AMD) department.

3. Responsibilities

• Analytical Scientist: Drafts the ATP based on the intended use and product quality requirements.
• Team Lead: Reviews ATP for scientific rationale and technical completeness.
• QA Representative: Ensures ATP meets documentation requirements and regulatory alignment.
• Head – AMD: Approves ATP and ensures it is referenced in all subsequent method development documentation.

4. Accountability

The Head of AMD is accountable for ensuring that all analytical method development activities are guided by a formally approved ATP that is scientifically justified and clearly defines method performance requirements.

5. Procedure

5.1 Definition and Importance of ATP

1. The ATP defines the objective of the analytical method by specifying what is to be measured and the required method performance criteria (e.g., precision, accuracy, range, detection limit).
2. The ATP acts as a benchmark for method design, optimization, and validation stages.

5.2 Initiation of ATP

1. Initiate ATP documentation during the early phase of product development or upon receipt of a method development request.
2. Assign ATP number in the format: ATP/YY/XXX (e.g., ATP/25/015).
3. Record initiation details in Annexure-1: ATP Tracker.

5.3 Structure of ATP Document

1. The ATP must include the following components:
   • Product/Analyte Identification
   • Method Objective (e.g., quantification, identification)
   • Analytical Technique (e.g., HPLC, GC, UV)
   • Performance Characteristics:
     • Accuracy (e.g., 98–102%)
     • Precision (e.g., %RSD ≤ 2%)
     • Specificity
     • Range and Linearity (e.g., 80–120%)
     • Detection and Quantitation Limits
   • Intended Use (e.g., assay for release testing)
   • Justification and Risk Assessment (if applicable)
2. Use Annexure-2: ATP Template for drafting.

5.4 Review and Approval

1. Submit the draft ATP to the Team Lead and QA.
2. Address feedback, finalize the document, and route for approval by Head – AMD.
3. Attach signed approval sheet as Annexure-3.

5.5 Implementation and Use

1. Reference ATP in all associated documents:
   • Method Development Protocol
   • Method Development Report
   • Validation Protocol and Report
2. Use ATP as the basis for establishing system suitability criteria and validation acceptance limits.
3. Maintain updated versions with documented justifications in case of revisions.

6. Abbreviations

• ATP: Analytical Target Profile
• AMD: Analytical Method Development
• RSD: Relative Standard Deviation
• HPLC: High-Performance Liquid Chromatography
• QA: Quality Assurance
• ICH: International Council for Harmonisation

7. Documents

1. ATP Tracker – Annexure-1
2. ATP Template – Annexure-2
3. ATP Approval Sheet – Annexure-3

8. References

• ICH Q8(R2) – Pharmaceutical Development
• ICH Q14 – Analytical Procedure Development (Draft)
• ICH Q2(R1) – Validation of Analytical Procedures
• WHO TRS 996 – Good Practices for Pharmaceutical Quality

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: ATP Tracker

ATP No.	Product	Date Initiated	Status	Version
ATP/25/015	Amlodipine Tablets	14/05/2025	Approved	1.0

Annexure-2: ATP Template

Section	Details
Analyte	Amlodipine
Objective	To quantify Amlodipine in tablets using RP-HPLC
Accuracy	98.0% – 102.0%
Precision	%RSD ≤ 2.0%
Range	80% – 120% of target concentration
Specificity	No interference from placebo or impurities
Detection	UV at 238 nm

Annexure-3: ATP Approval Sheet

Role	Name	Signature	Date
Prepared By
Reviewed By
Approved By

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Incorporated ICH Q14 framework and annexure-based documentation	Regulatory alignment