Standard Operating Procedure for Ensuring Product Sterility in Aseptic Processing

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for maintaining sterility throughout the aseptic processing of pharmaceutical products to ensure product safety and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in aseptic processing within the pharmaceutical manufacturing facility. It covers procedures for facility design, personnel training, environmental monitoring, and process controls.

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 processing operations following established procedures.

4) Procedure

4.1 Facility Design and Maintenance
4.1.1 Design aseptic processing areas to facilitate proper air filtration and segregation of critical and non-critical zones.
4.1.2 Implement a preventive maintenance program for HVAC systems and cleanroom equipment.
4.2 Personnel Training
4.2.1 Train personnel on aseptic techniques, gowning procedures, and behavior in cleanroom environments.
4.2.2 Conduct regular assessments and qualifications to ensure personnel competency.
4.3 Environmental Monitoring
4.3.1 Perform routine monitoring of viable and non-viable particles in critical and classified areas.
4.3.2 Document environmental monitoring results and investigate any excursions from established limits.
4.4 Process Controls
4.4.1 Establish and validate aseptic processing procedures, including filling, sealing, and sterilization processes.
4.4.2 Monitor critical process parameters such as temperature, pressure differentials, and sterilization cycles.
4.5 Sterility Assurance
4.5.1 Conduct routine sterility testing of finished products and process simulations (media fills).
4.5.2 Implement controls to prevent microbial contamination during all stages of production.
4.6 Documentation
4.6.1 Document all activities related to sterility assurance, including environmental monitoring data, process validations, and sterility test results.
4.6.2 Ensure that all records are reviewed and approved by the QA department.
4.7 Reporting
4.7.1 Prepare a sterility assurance report summarizing monitoring results, process validations, 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 from established procedures promptly.
4.8.2 Implement corrective and preventive actions to prevent recurrence of sterility assurance issues.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– HVAC: Heating, Ventilation, and Air Conditioning

6) Documents, if any

– Environmental Monitoring Reports
– Process Validation Reports
– Sterility Test 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