Standard Operating Procedure for Filling Volume Accuracy
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for ensuring the accuracy of filling volumes in the manufacturing of injectable products, including Intramuscular (IM) and Subcutaneous (SC) injections, to maintain product consistency and compliance with regulatory standards.
2) Scope
This SOP applies to all personnel involved in the filling process of injectable products within the pharmaceutical manufacturing facility. It covers the procedures for verifying and maintaining the accuracy of filling volumes.
3) Responsibilities
– Production Department: Responsible for carrying out the filling process and performing in-process checks.
– Quality Control (QC) Department: Responsible for conducting routine checks and verifications of filling volumes.
– Quality Assurance (QA) Department: Ensures that the procedures are followed and that records are maintained.
4) Procedure
4.1 Preparation
4.1.1 Ensure that the filling equipment is clean, calibrated, and ready for use.
4.1.2 Prepare the product and ensure that it meets all pre-filling specifications.
4.2 Filling Process
4.2.1 Set the filling machine to the predetermined volume settings based on the product specifications.
4.2.2 Perform a trial run with a small number of units to ensure the machine is dispensing the correct volume.
4.2.3 Adjust the machine settings
4.3 In-Process Checks
4.3.1 At the start of the filling operation, collect a sample of filled units (e.g., 5-10 units) and measure the volume using a calibrated measuring device.
4.3.2 Record the measured volumes and compare them to the target filling volume.
4.3.3 Repeat the checks at regular intervals (e.g., every hour or after a set number of units) during the filling process to ensure continued accuracy.
4.4 Volume Adjustment
4.4.1 If any discrepancies are found during in-process checks, stop the filling operation.
4.4.2 Identify the cause of the discrepancy and make necessary adjustments to the filling machine.
4.4.3 Perform another set of in-process checks to verify the adjustment before resuming full-scale production.
4.5 Documentation
4.5.1 Record all in-process checks, adjustments, and any deviations observed during the filling operation in the batch record.
4.5.2 Ensure that all records are reviewed and approved by the QA department.
4.6 Post-Production Verification
4.6.1 After the completion of the filling process, randomly select a sample of filled units (e.g., 10 units) for final volume verification.
4.6.2 Measure and record the volumes to confirm that they meet the specified criteria.
4.6.3 Document the results in the final batch record and submit them for QA review.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Batch Records
– In-Process Check Logs
– Calibration Records
– Final Verification Records
7) Reference, if any
– USP <1> Injections
– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
8) SOP Version
Version 1.0