Tag: FDA 21 CFR 211.113

Requalify Filter Integrity Every Six Months in GMP Manufacturing

Posted on By digi

Requalify Filter Integrity Every Six Months in GMP Manufacturing Do Requalify Filter Integrity Every Six Months in GMP Operations Remember: Scheduled requalification of filters — especially sterilizing-grade ones — is essential to ensure ongoing performance and GMP compliance. Why This Matters in GMP Sterile manufacturing relies on validated filters to remove microorganisms from air, water,…

Read More “Requalify Filter Integrity Every Six Months in GMP Manufacturing” »

GMP Tips

Never Leave Petri Dishes Open After Incubation in GMP Microbiology Labs

Posted on By digi

Never Leave Petri Dishes Open After Incubation in GMP Microbiology Labs Don’t Leave Petri Dishes Open Post-Incubation in GMP Microbiology Labs Remember: Always keep incubated petri dishes sealed — exposure post-incubation risks contamination, miscounts, and data integrity failures. Why This Matters in GMP Petri dishes are used for environmental monitoring, water testing, and product bioburden…

Read More “Never Leave Petri Dishes Open After Incubation in GMP Microbiology Labs” »

GMP Tips

Never Expose Empty Vials to Uncontrolled Environments in GMP Areas

Posted on By digi

Never Expose Empty Vials to Uncontrolled Environments in GMP Areas Don’t Expose Empty Vials to Uncontrolled Environments in GMP Settings Remember: Never leave empty sterile vials exposed in unclassified or uncontrolled environments — they are highly vulnerable to contamination. Why This Matters in GMP Empty sterile vials are critical components in aseptic processing, designed to…

Read More “Never Expose Empty Vials to Uncontrolled Environments in GMP Areas” »

GMP Tips

Perform Filter Integrity Testing Post-Use to Confirm Sterility Assurance

Posted on By digi

Perform Filter Integrity Testing Post-Use to Confirm Sterility Assurance Do Perform Integrity Testing of Filters After Use in Sterile Processes Remember: Always test the integrity of sterilized filters post-use — it confirms they performed as expected and ensures sterility assurance in GMP systems. Why This Matters in GMP Sterilizing-grade filters are critical to processes such…

Read More “Perform Filter Integrity Testing Post-Use to Confirm Sterility Assurance” »

GMP Tips

Use Biological Indicators for Sterilizer Validation in GMP Facilities

Posted on By digi

Use Biological Indicators for Sterilizer Validation in GMP Facilities Do Use Biological Indicators for Validating Sterilization Processes Remember: Always include biological indicators (BIs) during sterilizer validation — they confirm microbial kill effectiveness and support sterility assurance in GMP operations. Why This Matters in GMP Sterilizers — whether steam, dry heat, ethylene oxide, or radiation —…

Read More “Use Biological Indicators for Sterilizer Validation in GMP Facilities” »

GMP Tips

Never Transport Sterile Components Without Double Wrapping

Posted on By digi

Never Transport Sterile Components Without Double Wrapping Double Wrap Sterile Components During Transfer to Protect Aseptic Zones Remember: Never transfer sterile components into cleanrooms without double wrapping — this barrier system ensures aseptic integrity during transit. Why This Matters in GMP Sterile components such as stoppers, vial caps, filters, and other items used in aseptic…

Read More “Never Transport Sterile Components Without Double Wrapping” »

GMP Tips

Monitor Microbial Recovery Trends from Environmental Monitoring Data

Posted on By digi

Monitor Microbial Recovery Trends from Environmental Monitoring Data Track and Analyze Microbial Recovery Trends to Strengthen Contamination Control Remember: Never ignore trends in environmental monitoring data — even minor increases in microbial recovery can signal serious aseptic control issues. Why This Matters in GMP Environmental monitoring (EM) is essential for maintaining contamination control in pharmaceutical…

Read More “Monitor Microbial Recovery Trends from Environmental Monitoring Data” »

GMP Tips