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 manufacturer’s instructions.
4.3.3 Process vials through the inspection system and review the results.
4.4 Quality Control Testing
4.4.1 Take random samples of inspected vials for additional quality control tests (e.g., sterility, fill volume).
4.4.2 Record test results and compare them with established acceptance criteria.
4.4.3 If any vials fail the quality tests, investigate the cause and take corrective actions.
4.5 Documentation
4.5.1 Maintain records of all inspection activities, including visual and instrumental inspection results and quality control test results.
4.5.2 Ensure all records are signed and dated by the responsible personnel.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
6) Documents, if any
– Inspection Records
– Quality Control Test Records
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Inspection Equipment Manufacturer’s Manual
8) SOP Version
Version 1.0