QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 514

SOP No. QAS-032.00 Effective date: mm/dd/yyyy
Approved by:

Subject: Process Simulation (Media Fill) Test

51.1 PurPose
This SOP describes methods and procedures for conducting the process simulation test of sterile
products, including media fill procedures, media selection, incubation time and temperature, inspec-
tion of filled vials/ampoules, documentation, interpretation of results, and possible corrective
actions required. The main purposes of the SOP are to

• Demonstrate control over the aseptic operations
• Qualify aseptic processing (personnel, facility, equipment, environment, and procedures)
• Qualify aseptic techniques
• Comply with cGMP requirements

51.2 resPonsibility
It is the responsibility of all concerned department managers to follow the procedure. The
manufacturing director, quality control director, and QA director are responsible for SOP
compliance.

1. The manufacturing departments will be responsible for the following:

1.1 Scheduling of the validation runs

1.2 Raise media fill request form to all concerned departments with schedule (Attachment

No. I)

1.3 Provide operators involved in process simulation

1.4 Indicating responsible supervisory personnel

1.5 Perform media fill as per MFM and approved protocols

1.6 Provide the material and utilities to be used

1.7 Preparation of media

1.8 Clean the line after the run and prepare the area for real work

1.9 Review any major repairs

1.10 Review calibration status

2. The engineering and maintenance departments are responsible for the following:

2.1 Calibration of process equipment instrumentation on a regularly scheduled basis and/

or after repairs

2.2 Completion of major repairs/renovations prior to validation runs, if any

2.3 Provide historical data for temperature, humidity, pressure, and so on

2.4 Provide historical data for WFI and DI used during the media fill process

2.5 Participation and/or presence during media fill qualification

3. Quality control is responsible for the following:

3.1 Testing the microbial contamination and inspection of vials/ampoules

3.2 Area monitoring for viable count

3.3 Water testing

3.4 Media testing (bulk media and filled vials)

3.5 Compressed air testing (microbiologically)

3.6 Nitrogen gas testing (microbiologically)

3.7 CIP water (if applicable)