Standard Operating Procedure for Visual and Physical Inspection of Syringes and Vials

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting visual and physical inspections of syringes and vials to ensure product quality and compliance with specifications.

2) Scope

This SOP applies to all personnel involved in the visual and physical inspection of syringes and vials 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 and physical inspections and recording data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for inspection as per the testing protocol.

4) Procedure

4.1 Sample Collection
4.1.1 Collect representative samples of syringes and vials 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 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 the integrity of the syringe or vial, including the absence of cracks, chips, or other physical defects.
4.3.3 Verify the correctness and legibility of labels, including batch numbers, expiration dates, and any other required information.
4.3.4 Ensure the closure system (cap, stopper, or seal) is intact and properly seated.
4.4 Physical Inspection Process
4.4.1 Measure dimensions such as length, diameter, and volume to verify compliance with specifications.
4.4.2 Use appropriate measuring instruments (e.g., calipers, micrometers) for accurate measurements.
4.4.3 Check for the absence of defects that may affect functionality or usability.
4.5 Acceptance Criteria
4.5.1 Compare inspection results against predefined acceptance criteria and specifications.
4.5.2 Reject any syringes or vials that do not meet specified criteria and record the reasons for rejection.
4.6 Documentation
4.6.1 Document all inspection activities, including observations and test results, in the inspection logbook or electronic database.
4.6.2 Ensure that all records are reviewed and approved by the QC department.
4.7 Reporting
4.7.1 Prepare an inspection report summarizing the inspection process, results, and any deviations observed.
4.7.2 Submit the report to the QA department for review and approval.
4.8 Corrective Actions
4.8.1 Initiate an investigation into any identified deviations or non-conformities.
4.8.2 Implement corrective actions as necessary to prevent recurrence of issues.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Inspection Logbook
– Inspection Reports
– Non-Conformance Reports

7) Reference, if any

– USP <1> Injections and Implanted Drug Products (Parenterals) – Product Quality Tests
– ISO 8362-1:2021 Injection Containers and Accessories – Part 1: Injection Vials Made of Glass Tubing

8) SOP Version

Version 1.0