Standard Operating Procedure for Visual Inspection of Injectable Products

1) Purpose

This SOP outlines the procedures for visually inspecting injectable products to ensure they meet quality standards and are free from defects before release for distribution.

2) Scope

This SOP applies to the visual inspection of all injectable products, including vials, ampoules, and prefilled syringes, conducted in the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for conducting visual inspections. Production personnel are responsible for ensuring products are presented properly for inspection. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the inspection protocol and ensure all necessary materials and equipment are available (e.g., inspection booths, magnifying devices, light sources).
2. Verify the cleanliness and calibration of inspection equipment.
3. Train personnel involved in visual inspection on the protocol and criteria for acceptance/rejection.

4.2 Inspection Setup

1. Set up the inspection booth in a controlled environment with appropriate lighting (e.g., neutral background, uniform illumination).
2. Ensure proper handling and positioning of injectable products for inspection.

4.3 Visual Inspection

1. Inspect each injectable product for visible defects such as particles, cracks, discoloration, and container closure integrity.
2. Use magnification as needed to ensure thorough inspection of critical areas (e.g., vial neck, stopper).

4.4 Acceptance Criteria

1. Compare the inspected products against the acceptance criteria defined in the inspection protocol and product specifications.
2. Record the inspection results, including any deviations or observations.

4.5 Rejection and Rework

1. If defects are identified, segregate and reject non-conforming products.
2. Initiate rework procedures if applicable, following approved protocols.

4.6 Documentation

1. Document all inspection activities, including results, in the appropriate logbooks and records.
2. Prepare a visual inspection report summarizing findings for each batch inspected.

4.7 Reporting and Record Keeping

1. Review and approve the inspection report to ensure accuracy and compliance with regulatory requirements.
2. Maintain records of all visual inspections as per regulatory guidelines and internal procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Visual Inspection Protocol, Inspection Records, Visual Inspection Reports, Rejection and Rework Records

7) Reference, if any

Regulatory guidelines such as USP <790> Visible Particulates in Injections, USP <1790> Visual Inspection of Injections, European Pharmacopoeia (Ph. Eur.) 2.9.20 Particulate Contamination: Sub-Visible Particles, Ph. Eur. 2.9.3 Appearance of Solutions

8) SOP Version

Version 1.0