requirements (ICH Q6A/B), and support product quality throughout its lifecycle.

2. Scope

This SOP applies to personnel involved in the creation, review, and approval of analytical specifications within the Analytical Method Development (AMD), Quality Control (QC), Quality Assurance (QA), and Regulatory Affairs departments.

3. Responsibilities

• Analytical Scientist: Drafts the analytical specifications in consultation with the product development team and based on method capabilities.
• Team Lead: Reviews and approves specification rationales and technical suitability.
• QA: Ensures specifications meet regulatory and pharmacopoeial standards and are clearly defined.
• Regulatory Affairs: Ensures alignment with filing requirements and global market expectations.
• Head – AMD: Provides final approval for use and submission.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring all analytical specifications are technically sound, regulatory-compliant, and approved before implementation in validation and routine use.

5. Procedure

5.1 Specification Initiation

1. Initiate specification drafting at the completion of method development and prior to validation.
2. Assign Specification Code in format: SPEC/[Material Type]/[Product Code]/[Version]
3. Record in Annexure-1: Specification Register.

5.2 Components of a Specification Sheet

1. The specification document shall include the following sections:
   • Material Name and Code
   • Specification Type (e.g., API, finished product, excipient)
   • Test Parameters
   • Test Method (Pharmacopoeial / Non-Pharmacopoeial)
   • Acceptance Criteria
   • Reference Documents
2. Use the format defined in Annexure-2: Specification Template.

5.3 Selection and Justification of Tests

1. Include tests based on material type and risk assessment:
   • Identity
   • Assay
   • Impurities/Degradants
   • Residual solvents
   • Water content
   • Microbiological tests
2. Reference pharmacopoeias (e.g., IP, USP, BP, Ph. Eur.) and ICH Q6A/B as applicable.
3. Document justification in Annexure-3: Specification Justification Record.

5.4 Specification Limits

1. Set acceptance criteria based on:
   • Pharmacopoeial monographs
   • Clinical safety margins
   • Manufacturing process capability
   • Regulatory precedent
2. Ensure numerical limits include appropriate units and decimal precision.

5.5 Specification Review and Approval

1. Submit draft to QA, Regulatory Affairs, and Product Development for review.
2. Compile comments and finalize the specification sheet.
3. Approval from Head – AMD and QA Head is mandatory.
4. Record approval history in Annexure-4: Specification Approval Log.

5.6 Specification Revisions and Control

1. Trigger revisions in the event of:
   • Change in method
   • Change in product composition
   • New regulatory requirement
   • OOS investigation conclusions
2. Assign new version numbers and archive obsolete specifications.

6. Abbreviations

• AMD: Analytical Method Development
• QC: Quality Control
• QA: Quality Assurance
• OOS: Out of Specification
• USP: United States Pharmacopeia
• IP: Indian Pharmacopoeia
• ICH: International Council for Harmonisation

7. Documents

1. Specification Register – Annexure-1
2. Specification Template – Annexure-2
3. Specification Justification Record – Annexure-3
4. Specification Approval Log – Annexure-4

8. References

• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
• ICH Q6B – Specifications for Biotechnological Products
• ICH Q14 – Analytical Procedure Development
• WHO TRS 996 – Annex 3

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Specification Register

Spec Code	Material Name	Type	Version	Status
SPEC/API/AMLO/001	Amlodipine Besylate	API	1.0	Active

Annexure-2: Specification Template

Test	Method	Acceptance Criteria
Identification (IR)	Ph. Eur.	Conforms
Assay	HPLC	98.5% – 101.5%
Related Substances	HPLC	Total ≤ 1.0%

Annexure-3: Specification Justification Record

Test	Justification
Water Content	Required due to hygroscopic nature of API

Annexure-4: Specification Approval Log

Version	Date	Prepared By	Reviewed By	Approved By
1.0	18/05/2025	Sunita Reddy	Rajesh Kumar	Dr. Vinay Pawar

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Added justification and control revision sections	ICH Q6A alignment