and validation are appropriate for their intended use, traceable, and conform to applicable regulatory and GMP standards.

2. Scope

This SOP applies to all chemical reagents, buffers, indicators, titrants, and solvents used in the AMD laboratory for developing, optimizing, or validating analytical procedures for APIs, excipients, and formulations.

3. Responsibilities

• Analytical Scientist: Selects and initiates qualification for new or critical reagents used in method development.
• QA: Reviews and approves reagent qualification records and ensures traceability.
• Store Personnel: Ensures proper storage and labeling of reagents with status tags.
• Head – AMD: Approves qualified reagent status and resolves any discrepancies.

4. Accountability

The Head of AMD is accountable for ensuring that only qualified reagents are used in the development and validation of analytical methods.

5. Procedure

5.1 Reagent Selection

1. All reagents shall be of analytical reagent (AR), HPLC, or GC grade, unless otherwise justified.
2. Reference supplier specifications, compendial monographs, and material safety data sheets (MSDS).
3. Assign a unique Reagent ID number and document in Annexure-1: Reagent Qualification Log.

5.2 Receiving and Preliminary Inspection

1. Inspect reagents upon receipt for:
   • Supplier name and batch number
   • COA availability and compliance
   • Expiry date, manufacturing date, and packaging integrity
2. Initial assessment to be recorded in Annexure-2: Reagent Receipt and Inspection Checklist.

5.3 Reagent Testing and Verification

1. If COA is available:
   • Verify identification and assay using one or more analytical techniques (UV, IR, titration)
   • Compare values against pharmacopeial or internal specifications
2. If COA is not available or if reagent is critical (e.g., titrant, pH modifier):
   • Conduct full qualification testing as per Annexure-3: Reagent Testing Record
3. Qualified reagents shall be assigned a status tag: “Qualified for Use in AMD”

5.4 Labeling and Documentation

1. Each reagent container shall have a legible label stating:
   • Reagent name
   • Reagent ID
   • Date of opening
   • Use before date
   • Qualified By & Date
2. Update the Reagent Master List and qualification tracker maintained by QA.

5.5 Retesting and Requalification

1. Retest intervals:
   • 6 months for aqueous buffers
   • 12 months for acids, bases, or non-volatile solvents
2. Requalification to be documented in Annexure-4: Reagent Requalification Form.

5.6 Storage and Handling

1. Store qualified reagents in clean, ventilated chemical cabinets at designated temperature and humidity conditions.
2. Highly sensitive reagents (e.g., perchloric acid, iodine) to be stored with additional secondary containment.
3. Maintain usage logs for critical reagents in Annexure-5: Critical Reagent Usage Log.

5.7 Non-Conformance Management

1. If reagent fails qualification:
   • Label as “Rejected”
   • Segregate and record deviation in accordance with SOP/QMS/042/2025
2. Perform impact analysis for any methods developed using unqualified reagents.

6. Abbreviations

• AMD: Analytical Method Development
• QA: Quality Assurance
• COA: Certificate of Analysis
• MSDS: Material Safety Data Sheet
• SOP: Standard Operating Procedure

7. Documents

1. Reagent Qualification Log – Annexure-1
2. Reagent Receipt and Inspection Checklist – Annexure-2
3. Reagent Testing Record – Annexure-3
4. Reagent Requalification Form – Annexure-4
5. Critical Reagent Usage Log – Annexure-5

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• USP General Chapter <841> – Specific Gravity
• WHO TRS 986 Annex 2 – Good Practices for Quality Control Laboratories
• 21 CFR Part 211.84 – Testing and Approval of Components

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Reagent Qualification Log

Reagent ID	Reagent Name	Supplier	Batch No.	Qualification Date
RG-2025-017	Sodium Hydroxide	Rankem	NA25K7	02/05/2025

Annexure-2: Reagent Receipt and Inspection Checklist

Parameter	Status	Remarks
COA Present	Yes	Verified
Packaging Intact	Yes	No leakage
Expiry Date	Valid	Dec 2026

Annexure-3: Reagent Testing Record

Test Performed	Method	Result	Status
Identification (IR)	USP	Matches spectrum	Pass

Annexure-4: Reagent Requalification Form

Reagent ID	Requalification Date	Test Performed	Status
RG-2025-012	05/11/2025	pH Adjustment Efficiency	Pass

Annexure-5: Critical Reagent Usage Log

Date	Reagent ID	Analyst	Purpose	Remarks
06/05/2025	RG-2025-017	Ajay Verma	Titration Buffer Prep	Used as per SOP

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Added new annexures for requalification and usage tracking	GMP audit compliance