Standard Operating Procedure for Syringe Labeling and Inspection
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the labeling and inspection of syringes to ensure accurate labeling and detect any defects or non-conformities in the syringes intended for Intramuscular (IM) and Subcutaneous (SC) injections.
2) Scope
This SOP applies to all personnel involved in the labeling and inspection of syringes within the pharmaceutical manufacturing facility. It covers the procedures for equipment setup, labeling, inspection, and documentation.
3) Responsibilities
– Production Department: Responsible for performing the labeling and inspection process.
– Quality Control (QC) Department: Monitors the process to ensure compliance with specifications and records data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
4) Procedure
4.1 Equipment Setup
4.1.1 Ensure that the labeling machine is clean, calibrated, and ready for use.
4.1.2 Perform a pre-operation check to verify that all equipment components are functioning properly.
4.2 Preparation
4.2.1 Prepare the labels according to the batch record, ensuring that they include all required information such as product name, dosage, batch number, and expiration date.
4.2.2 Verify that the labels are free from defects and properly aligned.
4.3 Labeling Process
4.3.1 Load the prepared labels into the labeling machine.
4.3.2 Set up the labeling machine with the appropriate settings for the specific syringe size and label type.
4.3.3 Begin the labeling process, ensuring that each syringe is labeled accurately and securely.
4.3.4 Continuously monitor the labeling process for any discrepancies or deviations, such as misaligned or missing labels.
4.4 Inspection Process
4.4.1 Conduct a 100% visual inspection of the labeled syringes to check for any defects or non-conformities.
4.4.2 Inspect each syringe for proper label placement, legibility, and adherence.
4.4.3 Check for any physical defects in the syringe, such as cracks, leaks, or particulate contamination.
4.4.4 Segregate any syringes that do not meet the required specifications for further investigation.
4.5 Quality Control
4.5.1 Collect a representative sample of labeled syringes for quality control testing.
4.5.2 Perform additional tests if specified, such as adhesive strength or ink durability.
4.5.3 Record all quality control results in the batch record.
4.6 Documentation
4.6.1 Document all steps of the labeling and inspection process in the production 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 a batch production report summarizing the labeling and inspection process, including any deviations observed.
4.7.2 Submit the report to the QA department for review and approval.
4.8 Corrective Actions
4.8.1 If any labeled syringes do not meet specifications, initiate an investigation to identify the root cause.
4.8.2 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
– Batch Records
– Production Logbook
– QC Testing Reports
7) Reference, if any
– USP <1> Injections and Implanted Drug Products (Parenterals) – Product Quality Tests
– ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use
8) SOP Version
Version 1.0
