Procedure for Visual Inspection of Injectable Products
1) Purpose
The purpose of this SOP is to outline the procedure for visually inspecting injectable products to ensure they meet quality standards and are free from visible defects.
2) Scope
This SOP applies to all injectable products manufactured within the facility, including vials, ampoules, and pre-filled syringes.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing visual inspection and ensuring compliance with this SOP.
Production Department: Responsible for providing injectable products and supporting QC during inspection.
4) Procedure
4.1 Preparation:
4.1.1 Set up the visual inspection area under appropriate lighting conditions (e.g., controlled lighting booths).
4.1.2 Verify and calibrate inspection equipment, including magnifying lenses or automated inspection systems.
4.1.3 Ensure inspection personnel are trained and qualified to perform visual inspections.
4.2 Sample Selection:
4.2.1 Select representative samples of injectable products from different batches.
4.2.2 Ensure samples cover various container sizes, types, and production dates.
4.2.3 Handle samples carefully to avoid contamination or damage during inspection.
4.3 Visual Inspection:
4.3.1 Inspect each injectable product for visible defects such as particles, discoloration, cracks, and container closure defects.
4.3.2 Use appropriate inspection aids to enhance visibility and ensure thorough examination.
4.3.3 Follow standardized inspection protocols and acceptance criteria based on pharmacopeial standards or internal specifications.
4.4 Decision Making:
4.4.1 Classify inspected products as acceptable or unacceptable based on visual inspection findings.
4.4.2 Document any defects or deviations observed during inspection, including photographs if necessary.
4.4.3 Initiate further investigation or re-inspection of suspect products as per defined procedures.
4.5 Documentation:
4.5.1 Record all visual inspection procedures, results, and observations in the Visual Inspection Record.
4.5.2 Maintain detailed records of sample details, inspection conditions, and any corrective actions taken.
4.5.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Visual Inspection Record
Equipment Calibration Certificates
Sampling Plan Document
7) Reference, if any
USP General Chapter <790> – Visible Particulates in Injections
Pharmacopeial standards for Visual Inspection of Injectable Products
8) SOP Version
Version 1.0