Document Media Preparation Steps in GMP Microbiology Labs
Remember: Every step of media preparation—from weighing to sterilization—must be recorded to ensure traceability and compliance with microbiological testing standards.
Why This Matters in GMP
Culture media used in microbiological testing, such as sterility testing or environmental monitoring, directly influences the accuracy and reliability of results. Improper preparation or undocumented practices can lead to compromised media, false results, or invalidated tests. GMP requires that all media preparation steps—reagent weighing, pH adjustment, sterilization cycles, and lot traceability—be recorded and reviewed. This ensures that test results are reproducible, investigations are traceable, and data meets regulatory scrutiny. Media-related deviations can lead to batch release delays or regulatory action.
Regulatory and Compliance Implications
FDA 21 CFR Part 211.194 and 211.160 require accurate and complete laboratory records. WHO GMP and Schedule M specify that all reagents and media be traceable, tested, and documented. EU GMP Chapter 6 emphasizes the need for proper recordkeeping in microbiological laboratories. Regulatory audits review media logs, growth promotion test records, and equipment sterilization cycles. Lack of documentation may be treated as a data integrity breach or incomplete testing process.
Implementation Best Practices
- Maintain media preparation logbooks with date, preparer name, lot number, ingredients, and process steps.
- Include sterilization parameters and equipment ID for each batch of media.
- Perform and document growth promotion tests for each media lot before use.
- Label all prepared media with preparation date, expiry date, and storage conditions.
- Store retained samples of media batches used in critical testing for reference.
Regulatory References
- FDA 21 CFR Part 211.160 – Laboratory Controls
- FDA 21 CFR Part 211.194 – Laboratory Records
- EU GMP Chapter 6 – Microbiological Testing
- WHO GMP – Culture Media Preparation and Use
- Schedule M – Microbiological Lab Documentation Requirements