FDA 21 CFR 211.113 – Pharma GMP

Requalify Filter Integrity Every Six Months in GMP Manufacturing

digi — Fri, 07 Nov 2025 20:31:22 +0000

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,...

Never Leave Petri Dishes Open After Incubation in GMP Microbiology Labs

digi — Sun, 26 Oct 2025 17:16:49 +0000

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...

Never Expose Empty Vials to Uncontrolled Environments in GMP Areas

digi — Tue, 21 Oct 2025 20:11:43 +0000

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...

Perform Filter Integrity Testing Post-Use to Confirm Sterility Assurance

digi — Mon, 06 Oct 2025 11:45:02 +0000

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...

Use Biological Indicators for Sterilizer Validation in GMP Facilities

digi — Wed, 01 Oct 2025 10:38:32 +0000

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 —...

Never Transport Sterile Components Without Double Wrapping

digi — Mon, 01 Sep 2025 16:51:38 +0000

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...

Monitor Microbial Recovery Trends from Environmental Monitoring Data

digi — Thu, 28 Aug 2025 01:00:20 +0000

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...