Standard Operating Procedure for Inspection of Filled Vials

1) Purpose

The purpose of this SOP is to define the procedures for inspecting filled vials to ensure they meet quality and sterility standards before release.

2) Scope

This SOP applies to all personnel involved in the inspection of filled vials at [Company Name] for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Operators: Performing visual and instrumental inspections of filled vials.
– Quality Control (QC) Department: Conducting additional testing and verifying inspection results.
– Quality Assurance (QA) Department: Reviewing and approving inspection procedures and records.

4) Procedure

4.1 Preparation for Inspection
4.1.1 Ensure the inspection area is clean and properly illuminated.
4.1.2 Verify that inspection equipment is clean and calibrated.
4.2 Visual Inspection
4.2.1 Inspect each vial for visible defects such as cracks, leaks, particulate matter, or improper filling.
4.2.2 Rotate the vial slowly under good lighting to ensure all aspects are checked.
4.2.3 Separate any vials with visible defects for further evaluation.
4.3 Instrumental Inspection
4.3.1 Use automated inspection systems, if available, to detect defects that may not be visible to the naked eye.
4.3.2 Calibrate the inspection system according to the