Company Name], specifically during the inspection phase prior to plunger rod insertion and final sealing.

3. Responsibilities

• Production Operator: To perform real-time visual inspection of filled syringes on the conveyor belt and segregate defectives.
• IPQA Officer: To perform periodic inspection checks, confirm reject categorization, and maintain inspection records.
• Production Supervisor: To ensure line setup is correct and that trained personnel are deployed for inspection.
• Quality Assurance Manager: To review inspection reports and approve batch progression to sealing.

4. Accountability

The Head of Quality Assurance is accountable for the overall compliance with the inspection protocol and verification of inspection documentation.

5. Procedure

5.1 Pre-Inspection Setup

1. Ensure the inspection station is clean, sterile, and equipped with adequate illumination (1000–2000 Lux) and a black & white background panel.
2. Verify that all visual inspection personnel are trained and qualified with current validation records.
3. Review the batch manufacturing record (BMR) and confirm that filling operations are complete and in-process checks passed.
4. Ensure protective wear and gowning are as per aseptic guidelines.

5.2 Visual Inspection Process

1. Inspect each filled syringe for the following defects:
   • Presence of particles (fibers, glass, or rubber)
   • Air bubbles beyond allowable limits
   • Volume inconsistency
   • Discoloration or layering of solution
   • Plunger displacement or leakage
   • Damaged or misaligned syringe barrels
2. Rotate each syringe 360° against black and white backgrounds while gently inverting to detect floating or visible particles.
3. Reject syringes that fail to meet visual acceptance criteria and place them into the designated “Rejected Syringes Bin.”
4. Every 30 minutes, document the number of inspected and rejected syringes in the Inspection Log Sheet (Annexure-1).

5.3 Sampling and IPQA Verification

1. IPQA must verify 1% of the total inspected syringes every hour, randomly selected.
2. Cross-check for:
   • Volume variation using calibrated volumetric devices
   • Particle presence using reference visual guides
   • Compliance with defined acceptance quality limits (AQL)
3. Document the observations in the IPQA Verification Record (Annexure-2).

5.4 Defect Classification

Defects are classified as:

• Critical: Glass particles, microbial contamination, leakage – reject entire batch if trend observed.
• Major: Volume deviation, plunger misalignment – require 100% inspection of the batch.
• Minor: Cosmetic issues not impacting quality (e.g., minor scratches).

5.5 Handling of Rejections

1. Rejected syringes must be:
   • Documented with reason
   • Cross-verified by IPQA
   • Moved to a segregated and labeled container with “Rejected Syringes – Hold for Destruction” label
2. Ensure reconciliation of filled vs. rejected vs. sealed quantities post inspection.

5.6 Documentation and Batch Clearance

1. Upon completion of inspection, Production and QA must jointly:
   • Review inspection log sheets
   • Confirm acceptance limits are met
   • Approve continuation to the sealing stage
2. Attach inspection summary report to the BMR and retain records as per data integrity policy.

5.7 Line Clearance

1. After inspection and before sealing, IPQA must:
   • Perform line clearance
   • Ensure no rejected syringes are mixed with acceptable units
   • Confirm environmental monitoring results are within limits
2. Document line clearance in the Line Clearance Form (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• IPQA: In-Process Quality Assurance
• AQL: Acceptance Quality Limit
• BMR: Batch Manufacturing Record

7. Documents

1. Inspection Log Sheet – Annexure-1
2. IPQA Verification Record – Annexure-2
3. Line Clearance Form – Annexure-3

8. References

• WHO GMP Guidelines for Sterile Pharmaceutical Products
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• 21 CFR Part 211.110 – Sampling and Testing of In-Process Materials

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Production Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Inspection Log Sheet

Date	Batch No.	Time	No. Inspected	No. Rejected	Inspector
24/06/2025	SYN0625-02	10:00 AM	200	3	Rajesh Kumar

Annexure-2: IPQA Verification Record

Date	Batch No.	Sample Size	Defects Found	Result	Checked By
24/06/2025	SYN0625-02	10	None	Compliant	Sunita Reddy

Annexure-3: Line Clearance Form

Date	Batch No.	Area	Inspector	Clearance Time	Remarks
24/06/2025	SYN0625-02	Inspection Zone	Sunita Reddy	12:30 PM	Clean

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Updated with annexures and AQL classification	Periodic Review	QA Head