integrity, traceability, and compliance with cGMP requirements.

2. Scope

This SOP applies to all dispensing operations for primary packaging components used in prefilled syringes at the Sterile Injectable Manufacturing facility, covering receiving, cleaning verification, visual inspection, and documentation.

3. Responsibilities

• Warehouse Personnel: Responsible for dispensing, labeling, and recording of components.
• QA Executive: Verifies component cleanliness, documents compliance, and authorizes transfer.
• Production Operator: Receives, inspects, and verifies components prior to use.
• QC Analyst: Reviews CoA and sterility status of sterile components if applicable.

4. Accountability

The Head of Manufacturing shall ensure that only approved and sterile components are dispensed and tracked as per procedure. Non-compliance must be escalated for review.

5. Procedure

5.1 Material Request and Verification

1. Receive component requisition along with the BMR and production plan.
2. Verify availability, cleaning status, approval status, and packaging integrity.
3. Ensure all items are within expiry and carry appropriate status labels.

5.2 Visual Inspection and Clean Area Preparation

1. Perform 100% visual inspection of components for defects, black particles, scratches, or deformation.
2. Ensure dispensing area is sanitized and RLAF is operational with valid pressure and HEPA certification.
3. Arrange components and containers in a linear, segregated layout to prevent mix-ups.

5.3 Component Dispensing and Documentation

1. Open component packs only inside the RLAF using aseptic techniques.
2. Dispense the required number of pieces as per BMR with ±1% tolerance.
3. Document dispensing activity in the Component Dispensing Log (Annexure-1).
4. Ensure integrity of unused portions by resealing and labeling as “Partially Used – Not for Further Use” if single-use only.

5.4 Labeling and QA Release

1. Affix internal labels on all containers with: component name, quantity dispensed, date, operator initials.
2. Submit filled Approval and Release Form (Annexure-3) to QA for verification.
3. QA Officer signs off post-verification and authorizes staging for production.

5.5 Transfer to Aseptic Area

1. Transfer dispensed components in closed, sterile containers through approved material pass box.
2. Maintain separate movement logbook with time, quantity, and batch linkage.
3. Production to acknowledge receipt and perform visual re-verification before use.

6. Abbreviations

• SOP: Standard Operating Procedure
• PFS: Prefilled Syringe
• QA: Quality Assurance
• QC: Quality Control
• RLAF: Reverse Laminar Air Flow
• BMR: Batch Manufacturing Record

7. Documents

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

8. References

• WHO GMP Guidelines – Annex 6: Manufacture of Sterile Medicinal Products
• ICH Q8/Q9 – Pharmaceutical Development and Risk Management
• Schedule M – Indian GMP for Sterile Product Packaging

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Component Dispensing Log

Date	Component	Batch No.	Quantity	Dispensed By	Verified By
17/06/2025	PFS Barrel (5 mL)	PFS-23B001	10,000 Nos	Rajesh Kumar	Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Component	Batch No.	Test	Specification	Result	QA Reviewer
PFS Barrel	PFS-23B001	Visual & Dimensional	Pass	Pass	Ravi Sharma

Annexure-3: Approval and Release Form

Component Name	PFS Barrel (5 mL)
Batch Number	PFS-23B001
Quantity Dispensed	10,000 Nos
Date	17/06/2025
QA Approved By	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
15/02/2022	1.0	Initial version created	New Line – PFS Introduction	QA Head
17/06/2025	2.0	Component log and visual inspection steps added	GMP Enhancement	QA Head