bases, indicators, and special-purpose chemicals stored and used within the QC lab for routine testing and validation purposes.

3. Responsibilities

• QC Analyst: Ensure proper labeling of reagents and make appropriate entries in reagent logs during receipt, preparation, and usage.
• QC Store Assistant: Verify labels, manage storage, monitor expiry dates, and alert analysts for near-expiry reagents.
• QC Supervisor: Review reagent logbooks and verify compliance with SOP requirements.

4. Accountability

The QC Head is accountable for maintaining reagent labeling, storage conditions, traceability, and ensuring that expired reagents are promptly removed from use.

5. Procedure

5.1 Reagent Receipt and Labeling

1. Upon receiving chemical reagents, inspect containers for:
   • Intact seal and packaging
   • Batch number and Certificate of Analysis (CoA)
   • Expiry date and storage condition
2. Affix the internal QC label (Annexure-1) on the received reagent bottle, containing:
   • Name of reagent
   • Date of receipt and opening
   • Reagent ID number
   • Expiry date
   • Storage condition
   • Initials of person labeling
3. Enter receipt details in the Reagent Master Register (Annexure-2).

5.2 Reagent Storage

1. Store reagents based on the label’s recommended condition:
   • Ambient temperature
   • Refrigerated (2–8°C)
   • Light-sensitive (amber bottles)
2. Maintain separation for:
   • Acids and bases
   • Oxidizers and reducing agents
   • Volatile solvents
3. Clearly label and segregate expired reagents for disposal.

5.3 Reagent Preparation and Labeling

1. Use only approved reagents listed in the Reagent Master Register for reagent preparation.
2. During preparation, affix a freshly prepared reagent label (Annexure-3) with:
   • Prepared by (initials)
   • Preparation date and time
   • Concentration
   • Solvent used
   • Storage condition
   • Assigned reagent ID
   • Use before date
3. Make entries in the Reagent Preparation Log (Annexure-4).

5.4 Usage and Expiry Tracking

1. Each use of a reagent must be recorded in the Reagent Usage Log (Annexure-5) with:
   • Date
   • Reagent ID
   • Purpose of use
   • Initials
2. QC Store Assistant must perform a monthly review of all reagents approaching expiry within 30 days.
3. Expired reagents must be removed, marked “EXPIRED”, and transferred to the chemical disposal area.

5.5 Labeling Requirements

1. Labels must be:
   • Legible and permanently affixed
   • Water and solvent resistant
   • Not handwritten unless for immediate use preparations
2. Do not reuse containers or labels. Use fresh containers and labels for each new reagent preparation.

5.6 Disposal of Expired Reagents

1. Fill the Expired Reagent Disposal Form (Annexure-6) and submit to QA.
2. Disposal must be carried out in accordance with the chemical waste disposal SOP and local environmental laws.
3. Maintain records of disposal for at least 5 years.

5.7 Audit and Review

1. QA will perform quarterly audits of reagent logs, storage conditions, and labeling compliance.
2. Any non-compliance will result in CAPA and training for relevant staff.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis
• CAPA: Corrective and Preventive Action

7. Documents

1. Internal Reagent Label (Annexure-1)
2. Reagent Master Register (Annexure-2)
3. Prepared Reagent Label (Annexure-3)
4. Reagent Preparation Log (Annexure-4)
5. Reagent Usage Log (Annexure-5)
6. Expired Reagent Disposal Form (Annexure-6)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Subpart I: Laboratory Controls
• WHO TRS No. 1019 – Annex 4: Good Practices for Quality Control Labs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Internal Reagent Label Format

Reagent Name	Reagent ID	Date of Receipt	Expiry	Storage Condition
Sulfuric Acid	RG-2025-001	10/04/2025	10/04/2027	Ambient

Annexure-2: Reagent Master Register

Date	Reagent Name	Batch No.	CoA Available	Expiry	Initials
10/04/2025	Sodium Hydroxide	NAH25B03	Yes	10/04/2027	RK

Annexure-3: Prepared Reagent Label

Reagent Name	Concentration	Prepared On	Use Before	Prepared By
0.1N HCl	0.1N	12/04/2025	19/04/2025	SN

Annexure-4: Reagent Preparation Log

Date	Reagent Name	ID	Concentration	Prepared By	Checked By
12/04/2025	0.1N NaOH	RG-2025-008	0.1N	SK	PR

Annexure-5: Reagent Usage Log

Date	Reagent ID	Used For	Initials
13/04/2025	RG-2025-008	LOD testing	SR

Annexure-6: Expired Reagent Disposal Form

Reagent Name	ID	Expiry Date	Disposed On	Disposed By
Phenolphthalein	RG-2023-115	01/04/2025	10/04/2025	QA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	System Implementation	QA Head
14/04/2025	2.0	Integrated logs and disposal form	Regulatory alignment	QA Head