Standard Operating Procedure for Aseptic Media Fill Trials for IM and SC Injections
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting aseptic media fill trials to validate the aseptic filling process for Intramuscular (IM) and Subcutaneous (SC) injections.
2) Scope
This SOP applies to all personnel involved in the aseptic media fill trials within the pharmaceutical manufacturing facility. It covers procedures for trial design, execution, monitoring, and documentation.
3) Responsibilities
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Quality Control (QC) Department: Performs environmental monitoring and conducts sterility testing.
– Production Department: Executes aseptic media fill trials following established procedures.
4) Procedure
4.1 Trial Design
4.1.1 Define the objectives, acceptance criteria, and duration of the media fill trial.
4.1.2 Select a representative product formulation and fill volume for the trial.
4.2 Preparation
4.2.1 Prepare sterile components, including vials, stoppers, and caps, for the media fill trial.
4.2.2 Sterilize all equipment and materials involved in the filling process according to validated procedures.
4.3 Execution
4.3.1 Conduct the media fill trial in a classified area under conditions simulating routine production.
4.3.2 Monitor critical process parameters, including
4.4 Monitoring
4.4.1 Perform environmental monitoring during the media fill trial to assess the level of microbial contamination.
4.4.2 Record all observations, deviations, and interventions during the trial.
4.5 Evaluation
4.5.1 Evaluate the filled vials for physical defects and perform sterility testing on representative samples.
4.5.2 Compare trial results against predefined acceptance criteria to determine the trial outcome.
4.6 Documentation
4.6.1 Document all aspects of the media fill trial, including trial design, execution, and evaluation.
4.6.2 Ensure that all records are reviewed and approved by the QA department.
4.7 Reporting
4.7.1 Prepare a media fill trial report summarizing the trial design, execution, 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 Investigate and address any deviations or non-conformities identified during the media fill trial.
4.8.2 Implement corrective actions and preventive measures to improve the aseptic filling process.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
– IM: Intramuscular
– SC: Subcutaneous
6) Documents, if any
– Media Fill Trial Protocol
– Media Fill Trial Report
– Environmental Monitoring Reports
7) Reference, if any
– EU GMP Annex 1: Manufacture of Sterile Medicinal Products
– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
8) SOP Version
Version 1.0