to all reference and working standards (including pharmacopeial, in-house, and commercial standards) used for method development, validation, stability testing, and routine analysis within the Analytical Method Development (AMD) department.

3. Responsibilities

• Analytical Chemist: Prepares documentation, performs qualification testing, and labels the reference standard.
• QA Department: Reviews and approves qualification data and documentation.
• AMD Documentation Officer: Maintains inventory records and ensures periodic requalification.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that only qualified and approved reference standards are used in analytical operations and that they meet applicable regulatory and pharmacopeial requirements.

5. Procedure

5.1 Procurement and Receipt

1. Procure pharmacopeial standards from official sources (e.g., USP, EP, BP, IP) and certified in-house standards as per approved vendor list.
2. On receipt, verify Certificate of Analysis (CoA), lot number, purity, expiration date, and storage conditions.

5.2 Qualification of Reference Standards

1. Conduct identification and assay testing using validated methods.
2. For in-house standards, perform complete characterization including:
   • UV-Vis or IR spectroscopy
   • NMR, Mass spectrometry (if applicable)
   • Chromatographic purity (HPLC/GC)
3. Assign purity and content values with uncertainty if applicable.

5.3 Labeling

1. Affix label with the following details:
   • Name of standard
   • Batch/Lot number
   • Purity (%)
   • Assigned validity/expiration date
   • Storage condition (e.g., 2–8°C, desiccator)

5.4 Usage and Storage

1. Maintain usage log for each reference standard including date, analyst, quantity withdrawn, and purpose.
2. Store under recommended conditions and restrict access to authorized personnel only.
3. Ensure that standards nearing expiration are highlighted for requalification or replacement.

5.5 Requalification

1. Conduct requalification every 12 months or upon suspicion of degradation (e.g., physical changes).
2. Repeat assay and identification testing.
3. Document results and update labeling and records accordingly.

6. Abbreviations

• CoA: Certificate of Analysis
• USP: United States Pharmacopeia
• EP: European Pharmacopeia
• NMR: Nuclear Magnetic Resonance
• GC: Gas Chromatography

7. Documents

1. Annexure-1: Qualification Template for Reference Standards
2. Annexure-2: Reference Standard Inventory Log
3. Annexure-3: Requalification Checklist

8. References

• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
• Pharmacopeial guidelines (USP, EP, BP, IP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Mohit Sinha	Ritika Sharma	Dr. A.K. Verma
Designation	Analyst	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Qualification Template for Reference Standards

Includes standard name, batch, supplier, assay result, identity confirmation, spectroscopic and chromatographic data, signature of analyst and QA reviewer.

Annexure-2: Reference Standard Inventory Log

Standard Name	Batch No.	Quantity Received	Storage	Expiry	Status
Paracetamol RS	RS-PAR-25	5g	2–8°C	May 2026	Active

Annexure-3: Requalification Checklist

Checklist to ensure requalification is performed on time, includes criteria like physical appearance, assay, identity, updated labeling, and documentation.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added NMR and GC requirements for in-house standards	Periodic Review	Dr. A.K. Verma
15/07/2022	1.0	Initial version	New SOP	QA Head