Standard Operating Procedure for Online Inspection during Injectable Manufacturing

Department	Sterile Injectable Manufacturing
SOP No.	SOP/SIM/038/2025
Supersedes	SOP/SIM/038/2022
Page No.	Page 1 of 13
Issue Date	18/06/2025
Effective Date	20/06/2025
Review Date	18/06/2026

1. Purpose

This SOP outlines the procedure for online inspection of injectable products during manufacturing to ensure quality, accuracy, and compliance with GMP guidelines. The goal is to detect any defects or deviations in real time and take corrective actions immediately.

2. Scope

This procedure applies to the online inspection of vials, ampoules, and prefilled syringes during filling, sealing, and labeling operations within the sterile manufacturing facility.

3. Responsibilities

• Operators: Perform continuous inspection and report abnormalities during manufacturing.
• In-Process QA: Monitors compliance with inspection protocols and documents observations.
• Production Supervisor: Ensures inspection stations are manned and defects are segregated.
• Engineering: Maintains inspection lighting and conveyor functionality.

4. Accountability

The Head of Production is accountable for implementing and enforcing online inspection procedures and ensuring timely resolution of any quality deviations observed during the process.

5. Procedure

5.1 Inspection Setup

1. Ensure that visual inspection areas are equipped with:
   • Proper lighting (5000 to 5400 Lux)
   • Black and white background screens
   • Turntables or conveyor belts (if applicable)
2. Clean the inspection area before batch startup and record in the Cleaning Log.
3. Verify batch details and affix appropriate product labels at inspection points.

5.2 Types of Inspections

1. Visual Inspection for Particulate Matter: Observe the product against light for visible particles.
2. Seal Integrity Check: Confirm the integrity of rubber stoppers, crimping, or syringe closures.
3. Fill Volume Check: Verify fill volume using reference standards at defined intervals.
4. Label Verification: Ensure correct labeling, alignment, and legibility.

5.3 Frequency and Sampling

1. Inspect every unit manually or via automated camera-based systems, as per equipment capabilities.
2. Sample every 15 minutes for fill volume and sealing defects using random samples (Annexure-1).
3. QA to cross-verify 1% of inspected lots hourly and record results (Annexure-2).

5.4 Defect Classification

1. Critical: Particulate matter, wrong product, missing closure.
2. Major: Improper fill volume, loose seals, mislabeling.
3. Minor: Aesthetic issues, slight label skew.
4. Segregate defective products in a red-labeled container and record in Defect Log (Annexure-3).

5.5 Action on Rejection

1. QA must evaluate high defect rates (≥ 1% in 30-minute interval) and initiate deviation report.
2. All affected containers must be quarantined and assessed for potential reinspection or rejection.
3. Root cause analysis and CAPA shall be initiated as per QA guidelines.

5.6 Documentation

1. Complete the Online Inspection Log for each shift and batch.
2. Defect summary shall be included in Batch Manufacturing Record (BMR).
3. Maintain inspection logs for a minimum of 5 years.

6. Abbreviations

• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record

7. Documents

1. Inspection Checklist – Annexure-1
2. QA Verification Record – Annexure-2
3. Defect Log Sheet – Annexure-3

8. References

• WHO TRS 961 Annex 6
• EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• ICH Q8 (R2) – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Inspection Checklist

Date	Time	Batch No.	Defect Type	Units Checked	Units Rejected	Inspected By
18/06/2025	10:30	IM-2205	Particulate	100	2	Rajesh Kumar

Annexure-2: QA Verification Record

Time	Checked Units	Findings	QA Signature
11:00	50	No Defects	Neha Sharma

Annexure-3: Defect Log Sheet

Date	Batch No.	Defect Type	No. of Units	Disposition	Remarks
18/06/2025	IM-2205	Loose Seal	3	Rejected	Line recalibrated

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Added Annexures and inspection frequency table	Annual Review	QA Head