Standard Operating Procedure for Needle Assembly for Pre-filled Syringes

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the proper assembly of needles on pre-filled syringes intended for Intramuscular (IM) and Subcutaneous (SC) injections, ensuring that the final product is safe, effective, and meets quality standards.

2) Scope

This SOP applies to all personnel involved in the needle assembly process for pre-filled syringes within the pharmaceutical manufacturing facility. It covers the procedures for assembly, inspection, and documentation.

3) Responsibilities

– Production Department: Responsible for the assembly of needles on pre-filled syringes.
– Quality Control (QC) Department: Conducts inspections and tests to ensure assembly quality.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.

4) Procedure

4.1 Preparation
4.1.1 Gather all necessary materials, including pre-filled syringes, needles, and assembly equipment.
4.1.2 Verify that all materials are within their expiration dates and free from defects.
4.2 Assembly Process
4.2.1 Set up the needle assembly equipment according to the manufacturer’s instructions.
4.2.2 Place the pre-filled syringes in the designated holders on the assembly line.
4.2.3 Attach the needles to the syringes by following the automated or manual assembly process.
4.2.4 Ensure that each needle is securely attached and properly aligned with the syringe barrel.
4.3 Inspection
4.3.1 Conduct a visual inspection of the assembled syringes to check for any defects, such as misaligned needles or loose fittings.
4.3.2 Perform functional tests, such as checking for proper needle attachment and fluid flow, on a representative sample of syringes.
4.4 Quality Control
4.4.1 Collect samples from the assembled batch for further testing, including sterility and functionality tests.
4.4.2 Record all inspection and test results in the batch record.
4.5 Documentation
4.5.1 Document the needle assembly process, including any deviations or issues encountered, in the production logbook or electronic database.
4.5.2 Ensure that all records are reviewed and approved by the QC department.
4.6 Reporting
4.6.1 Prepare a batch production report summarizing the needle assembly process, results, and any deviations observed.
4.6.2 Submit the report to the QA department for review and approval.
4.7 Corrective Actions
4.7.1 If any defects or issues are identified, initiate an investigation to determine the root cause.
4.7.2 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

– ISO 11608-1:2014 Needle-based Injection Systems for Medical Use – Requirements and Test Methods
– USP <1> Injections and Implanted Drug Products (Parenterals) – Product Quality Tests

8) SOP Version

Version 1.0