Standard Operating Procedure for Packaging and Labeling of Syringes and Vials
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the packaging and labeling of syringes and vials to ensure that the final product is correctly labeled, securely packaged, and ready for distribution.
2) Scope
This SOP applies to all personnel involved in the packaging and labeling of syringes and vials within the pharmaceutical manufacturing facility. It covers the procedures for packaging, labeling, inspection, and documentation.
3) Responsibilities
– Production Department: Responsible for the packaging and labeling of syringes and vials.
– Quality Control (QC) Department: Conducts inspections to ensure packaging and labeling quality.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
4) Procedure
4.1 Preparation – QC: Quality Control – Batch Records – USP <1> Injections and Implanted Drug Products (Parenterals) – Product Quality Tests Version 1.0
4.1.1 Gather all necessary materials, including syringes, vials, labels, and packaging components.
4.1.2 Verify that all materials are within their expiration dates and free from defects.
4.2 Packaging Process
4.2.1 Set up the packaging line according to the manufacturer’s instructions.
4.2.2 Place the syringes and vials in the designated holders on the packaging line.
4.2.3 Ensure that each syringe and vial is securely sealed and properly positioned in its packaging.
4.3 Labeling Process
4.3.2 Set up the labeling machine with the appropriate settings for the specific syringe and vial sizes.
4.3.3 Begin the labeling process, ensuring that each syringe and vial is labeled accurately and securely.
4.3.4 Continuously monitor the labeling process for any discrepancies or deviations.
4.4 Inspection
4.4.1 Conduct a 100% visual inspection of the packaged and labeled syringes and vials to check for any defects or non-conformities.
4.4.2 Inspect each package for proper label placement, legibility, and adherence.
4.4.3 Check for any physical defects in the packaging, such as damaged boxes or missing components.
4.5 Quality Control
4.5.1 Collect a representative sample of packaged and labeled syringes and vials 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 packaging and labeling 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 packaging and labeling 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 packaged or labeled syringes and vials 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
– QA: Quality Assurance6) Documents, if any
– Production Logbook
– QC Testing Reports7) Reference, if any
– ISO 11607-1:2019 Packaging for Terminally Sterilized Medical Devices – Requirements for Materials, Sterile Barrier Systems, and Packaging Systems8) SOP Version