visual inspection activities performed on all sterile injectable drug products manufactured in the facility, including vials, ampoules, and prefilled syringes.

3. Responsibilities

• Visual Inspectors: Responsible for conducting inspection and segregating defective units.
• IPQA Personnel: Responsible for oversight and verification of the inspection process.
• Production Supervisor: Ensures that inspection is performed as per SOP.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that all injectable products are visually inspected as per cGMP standards before batch release.

5. Procedure

5.1 Preparation

1. Ensure that inspectors are trained and qualified for visual inspection as per SOP.
2. Perform the inspection in a controlled lighting environment (2000–3750 lux) with black and white backgrounds.
3. Allow inspector to adapt eyes to the lighting conditions for at least 5 minutes before inspection begins.

5.2 Inspection Process

1. Take inspected products from the quarantine area and place them in trays.
2. Visually inspect each unit against black and white background for:
   • Clarity of solution
   • Presence of foreign particles or fibers
   • Color changes or turbidity
   • Glass defects (cracks, spots)
3. Rotate the container slowly in front of the light and observe any suspended particles.
4. Reject any unit showing the above defects and segregate into the “Rejected” tray.

5.3 Sampling & Frequency

1. Perform 100% inspection for every batch.
2. Record observations on the Visual Inspection Record Sheet (Annexure-1).

5.4 Handling of Rejected Units

1. Label and store rejected units in a separate area for QA decision.
2. Record reasons for rejection and batch number in Rejection Logbook (Annexure-2).

5.5 Double Inspection (Optional)

1. If required by protocol, conduct a second visual inspection by a different qualified inspector.
2. Compare results and resolve any discrepancies before batch approval.

5.6 Post-Inspection

1. Move accepted units to the approved quarantine area.
2. Submit inspection reports to QA for batch disposition.

6. Abbreviations

• SOP: Standard Operating Procedure
• IPQA: In-Process Quality Assurance
• QA: Quality Assurance
• cGMP: Current Good Manufacturing Practice

7. Documents

1. Visual Inspection Record Sheet – Annexure-1
2. Rejection Logbook – Annexure-2
3. Lighting Calibration Log – Annexure-3

8. References

• USP <790> – Visible Particulates in Injections
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• ICH Q9 – Quality Risk Management

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: Visual Inspection Record Sheet

Batch No.	Date	Total Units	Rejected	Inspected By
VCL-2025	17/06/2025	10,000	12	Ajay Verma

Annexure-2: Rejection Logbook

Date	Batch No.	Defect Type	Quantity	Remarks
17/06/2025	VCL-2025	Fiber in solution	6	To be evaluated by QA

Annexure-3: Lighting Calibration Log

Date	Location	Lux Reading	Checked By	Status
15/06/2025	Inspection Booth 2	3250	Sunita Reddy	Pass

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/02/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Double inspection process added	Periodic Review	QA Head