Standard Operating Procedure for Visual Inspection of Injectable Products

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting visual inspections of injectable pharmaceutical products, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure product quality and compliance with specifications.

2) Scope

This SOP applies to all personnel involved in the visual inspection of injectable products within the pharmaceutical manufacturing facility. It covers the procedures for sample collection, inspection, and documentation.

3) Responsibilities

– Quality Control (QC) Department: Responsible for performing visual inspections and recording data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for visual inspection as per the testing protocol.

4) Procedure

4.1 Sample Collection
4.1.1 Collect representative samples of the injectable products as per the sampling plan.
4.1.2 Ensure samples are properly labeled with batch number and manufacturing date.
4.2 Inspection Environment
4.2.1 Conduct visual inspections in a well-lit area free from distractions.
4.2.2 Use a black and white background to enhance the visibility of particulate matter and other defects.
4.3 Visual Inspection Process
4.3.1 Inspect each sample for clarity, color, and presence of particulate matter.
4.3.2 Check for any visible defects in the container, such as cracks, leaks, or improper seals.
4.3.3 Inspect the labeling for accuracy and adherence to specifications.
4.4 Documentation
4.4.1 Document all inspection results, including observations and any defects identified, in the visual inspection logbook or electronic database.
4.4.2 Ensure that all records are reviewed and approved by the QC department.
4.5 Reporting
4.5.1 Prepare a visual inspection report summarizing the methodology, results, and any deviations observed.
4.5.2 Submit the report to the QA department for review and approval.
4.6 Corrective Actions
4.6.1 If any defects are identified, initiate an investigation to determine the root cause.
4.6.2 Implement corrective actions as necessary and document all findings and actions taken.

5) Abbreviations, if any

– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Visual Inspection Logbook
– Visual Inspection Reports
– Batch Records

7) Reference, if any

– USP <1790> Visual Inspection of Injectable Products
– ISO 2859-1:1999 Sampling Procedures for Inspection by Attributes

8) SOP Version

Version 1.0