FDA recommendations for Media Fills

In its warning letter to Bhargava Phytolab Private Limited, the FDA criticised the company for failing to conduct media fills, which is a crucial part of validating aseptic filling processes for sterile drug products. According to 21 CFR 211.113(b), the FDA requires companies to implement written procedures to prevent microbiological contamination, including the validation of aseptic processes.

Media fills are essential to demonstrate that a company’s aseptic processes are under control. They simulate the filling of a sterile drug product using a microbiological growth medium to verify that the process prevents contamination.

The FDA expects the company to:

• Provide details of improvements to ensure all sterile products are manufactured in controlled aseptic conditions.
• Establish specifications for microbiological and chemical quality.
• Provide a detailed sterilisation method for equipment and validation protocols.
• Offer a summary of the media fill programme, including worst-case scenarios, analysis methods for growth, and batch yield assessments.

Conclusion: Media fills are a vital step in ensuring aseptic processing and demonstrating compliance with Good Manufacturing Practices (GMPs) for sterile products.

05-05-2025