guidelines.

2. Scope

This SOP is applicable to all activities involved in the dispensing of raw materials—active ingredients and excipients—used in the formulation of intradermal injections at the Sterile Injectable Manufacturing department.

3. Responsibilities

• Stores Chemist: Responsible for physical dispensing, weighing, and labeling of materials.
• QA Officer: Monitors SOP compliance, verifies documentation, and authorizes release.
• Production Officer: Ensures correct material is received and used per batch requirements.
• QC Analyst: Confirms material suitability based on CoA and retesting as needed.

4. Accountability

The Head of Manufacturing is accountable for the implementation, compliance, and periodic review of this SOP.

5. Procedure

5.1 Material Request Review

1. Receive Material Requisition Note (MRN) from production with all required details.
2. Cross-verify with the Batch Manufacturing Record (BMR) for quantities and specification alignment.
3. Ensure materials are approved, within expiry, and accompanied by valid CoAs.

5.2 Dispensing Area Preparation

1. Ensure dispensing booth is cleaned, sanitized, and the RLAF unit is operational.
2. Review equipment logbooks to confirm cleaning and calibration status.
3. Arrange pre-cleaned utensils and containers in the designated area.

5.3 Weighing and Dispensing

1. Clean the outer surfaces of material containers with 70% IPA.
2. Bring materials into the weighing booth one at a time to prevent mix-up.
3. Dispense raw materials using calibrated balances. Tolerance: ±0.1%.
4. Use designated scoops/utensils for each material to avoid cross-contamination.
5. Record details immediately in the Material Dispensing Log (Annexure-1).

5.4 Labeling and QA Review

1. Label each dispensed material with the name, batch no., quantity, date, and operator initials.
2. QA officer verifies dispensed quantity, CoA, label, and documentation.
3. Fill the Approval and Release Form (Annexure-3) and obtain QA signature.

5.5 Release to Production

1. Transfer labeled materials to staging area under appropriate conditions.
2. Production personnel verify receipt and sign the acknowledgment.
3. File all original records in the batch folder for traceability and audit readiness.

6. Abbreviations

• SOP: Standard Operating Procedure
• ID: Intradermal
• MRN: Material Requisition Note
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis
• RLAF: Reverse Laminar Air Flow

7. Documents

1. Material Dispensing Log – Annexure-1
2. Certificate of Analysis (CoA) – Annexure-2
3. Approval and Release Form – Annexure-3

8. References

• WHO TRS 986 Annex 2 – GMP for Sterile Pharmaceutical Products
• ICH Q10 – Pharmaceutical Quality System
• Schedule M – Indian GMP Requirements

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Store Chemist	QA Officer	Head – Manufacturing
Department	Warehouse	Quality Assurance	Sterile Injectable Manufacturing

11. Annexures

Annexure-1: Material Dispensing Log

Date	Material	Batch No.	Qty Dispensed	Dispensed By	Verified By
17/06/2025	Phenol	ID-2025-B001	10 mL	Rajesh Kumar	Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Material	Batch No.	Test	Specification	Result	Approved By
Phenol	ID-2025-B001	Purity	≥99.0%	99.6%	Ravi Sharma

Annexure-3: Approval and Release Form

Material Name	Phenol
Batch Number	ID-2025-B001
Quantity Dispensed	10 mL
Date	17/06/2025
QA Approved By	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
12/02/2022	1.0	Initial release	New formulation facility	QA Head
17/06/2025	2.0	Annexures updated, RLAF section added	Annual Review	QA Head