Tag: Schedule M

Never Adjust Cleanroom Thermostats Without QA Notification

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Never Adjust Cleanroom Thermostats Without QA Notification Do Not Adjust Cleanroom Thermostats Without QA Authorization Remember: Any change to cleanroom temperature settings must be done only after QA approval—unauthorized changes can lead to GMP violations. Why This Matters in GMP Cleanroom environments rely on strict control of temperature, humidity, pressure, and airflow to maintain classification…

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GMP Tips

Wear Overshoes Before Entering Grade C Zones to Maintain GMP Hygiene

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Wear Overshoes Before Entering Grade C Zones to Maintain GMP Hygiene Use Overshoes When Entering Grade C Cleanroom Areas Remember: Wearing overshoes before entering Grade C zones is a mandatory step in cleanroom gowning to minimize contamination from external footwear. Why This Matters in GMP Footwear is a significant vector for introducing external contaminants—dust, microbes,…

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GMP Tips

Do Not Overfill Waste Bins in GMP Cleanrooms to Prevent Contamination

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Do Not Overfill Waste Bins in GMP Cleanrooms to Prevent Contamination Do Not Allow Waste Bins to Overflow in GMP Cleanrooms Remember: Waste containers in cleanrooms must be emptied regularly—overflowing bins pose microbial and particulate contamination risks. Why This Matters in GMP Waste bins in GMP environments collect used materials, garments, wipes, and discarded packaging—all…

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GMP Tips

Document All Media Preparation Steps in GMP Microbiology Laboratories

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Document All Media Preparation Steps in GMP Microbiology Laboratories 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,…

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GMP Tips

Do Not Use Laboratory Glassware with Faded or Unreadable Calibration Marks

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Do Not Use Laboratory Glassware with Faded or Unreadable Calibration Marks Discard Glassware with Illegible Calibrations in GMP Laboratories Remember: Laboratory glassware with unreadable volume markings must not be used—accurate measurements are essential for GMP analytical reliability. Why This Matters in GMP Accurate analytical testing relies heavily on the precision of volumetric instruments such as…

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GMP Tips

Maintain Airlocks Under Positive Pressure in GMP Classified Areas

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Maintain Airlocks Under Positive Pressure in GMP Classified Areas Maintain Positive Pressure in Airlocks to Control Cleanroom Contamination Remember: Airlocks must maintain positive pressure relative to adjacent lower-grade areas to prevent contamination ingress in GMP zones. Why This Matters in GMP Airlocks are transition spaces between cleanroom zones of differing classifications. Maintaining positive pressure in…

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GMP Tips

Do Not Conduct Repairs During Batch Production in GMP Facilities

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Do Not Conduct Repairs During Batch Production in GMP Facilities Avoid Conducting Equipment Repairs During Active Batch Processing Remember: Do not perform any maintenance or repairs on equipment or systems during batch processing without risk assessment and QA approval. Why This Matters in GMP Repairs during ongoing batch production introduce uncontrolled elements into a validated…

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GMP Tips

Use Barcode Scanning to Enhance Material Traceability in GMP

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Use Barcode Scanning to Enhance Material Traceability in GMP Implement Barcode Scanning for Accurate GMP Material Traceability Remember: Barcoding minimizes manual errors and improves inventory control—GMP demands traceable material movement from receipt to dispatch. Why This Matters in GMP Manual entry of material information is prone to transcription errors, omissions, and mislabeling, especially in high-volume…

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GMP Tips

Do Not Allow Flaking Paint in GMP Controlled Manufacturing Environments

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Do Not Allow Flaking Paint in GMP Controlled Manufacturing Environments Flaking Paint Must Be Eliminated from GMP Controlled Areas Remember: Peeling paint is an unacceptable contamination source in GMP areas—facilities must be maintained to prevent such physical degradation. Why This Matters in GMP Facility walls and ceilings must be constructed and maintained to minimize particle…

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GMP Tips

Periodically Verify Water for Injection (WFI) Quality in GMP Operations

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Periodically Verify Water for Injection (WFI) Quality in GMP Operations Regularly Test Water for Injection to Maintain GMP Compliance Remember: WFI must be tested periodically for microbial and chemical contaminants—GMP requires strict monitoring to ensure pharmaceutical-grade water quality. Why This Matters in GMP Water for Injection (WFI) is the highest purity water used in pharmaceutical…

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GMP Tips