Tag: Schedule M

Never Handle Rejected Goods During Active GMP Production

June 15, 2025 digi

Never Handle Rejected Goods During Active GMP Production Rejected Goods Must Not Be Handled During Batch Production Remember: GMP requires that rejected goods be segregated and not accessed during live production to prevent cross-contamination or mix-ups. Why This Matters in GMP Rejected materials, whether due to deviation, damage, or test failure, are considered unfit for…

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Ensure QA Oversight in Destruction of GMP Rejected Products

June 14, 2025 digi

Ensure QA Oversight in Destruction of GMP Rejected Products Assign QA Oversight to Product Destruction Activities in GMP Remember: Product destruction must always be supervised and documented by QA to ensure traceability, prevent misuse, and maintain GMP compliance. Why This Matters in GMP Rejected products, expired drugs, or returned goods must be destroyed in a…

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Never Use Fiber-Shedding Materials for Machine Cleaning in GMP Areas

June 14, 2025 digi

Never Use Fiber-Shedding Materials for Machine Cleaning in GMP Areas Avoid Fiber-Shedding Materials for GMP Equipment Cleaning Remember: GMP cleaning must use non-shedding, low-lint materials—fiber-releasing cloths can lead to product contamination and audit failures. Why This Matters in GMP Cleaning is a key contamination control strategy in pharmaceutical manufacturing. However, using inappropriate materials—like cotton rags,…

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Review Environmental Monitoring Data Trends to Ensure GMP Compliance

June 13, 2025 digi

Review Environmental Monitoring Data Trends to Ensure GMP Compliance Trend Environmental Monitoring Data to Strengthen GMP Controls Remember: GMP requires not just environmental monitoring—but regular trend analysis of results to detect early warning signs and prevent excursions. Why This Matters in GMP Environmental Monitoring (EM) is a core GMP requirement for cleanrooms and sterile zones….

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Avoid Water Stagnation in GMP Drains and Sinks to Prevent Contamination

June 13, 2025 digi

Avoid Water Stagnation in GMP Drains and Sinks to Prevent Contamination Prevent Water Stagnation in Drains and Sinks to Avoid Microbial Risk Remember: Water stagnation in GMP areas is a major source of microbial growth—ensure drains and sinks are regularly inspected, cleaned, and dried. Why This Matters in GMP Standing water is a fertile breeding…

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Test Compressed Air for Microbial Contamination in GMP Utilities

June 12, 2025 digi

Test Compressed Air for Microbial Contamination in GMP Utilities Verify Compressed Air for Microbial Contamination in GMP Operations Remember: Compressed air used in manufacturing must be monitored routinely for microbial and particulate contamination to ensure utility integrity. Why This Matters in GMP Compressed air is extensively used in pharmaceutical manufacturing—for equipment operation, product contact applications,…

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Always Perform Swab Sampling After Cleaning Validation

June 12, 2025 digi

Always Perform Swab Sampling After Cleaning Validation Conduct Swab Sampling Post Cleaning Validation to Confirm Effectiveness Remember: Swab sampling must be performed after cleaning validation to ensure no residues or contaminants remain before equipment reuse. Why This Matters in GMP Cleaning validation establishes that manufacturing equipment can be cleaned to a predetermined level of cleanliness….

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Verify Integrity of Double-Door Pass Boxes to Prevent Cross Contamination

June 12, 2025 digi

Verify Integrity of Double-Door Pass Boxes to Prevent Cross Contamination Ensure Proper Functioning of Double-Door Pass Boxes in GMP Cleanrooms Remember: GMP mandates validated, interlocked pass boxes with door integrity checks to prevent contamination during material transfer between classified areas. Why This Matters in GMP Pass boxes act as controlled transfer points between rooms of…

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Never Introduce Uncontrolled Paper Materials into Sterile GMP Areas

June 11, 2025 digi

Never Introduce Uncontrolled Paper Materials into Sterile GMP Areas Do Not Introduce Uncontrolled Paper Into Sterile Areas Remember: Paper materials must be controlled, sterile-compatible, and pre-approved before entering aseptic environments to avoid particulate and microbial contamination. Why This Matters in GMP Conventional paper products are a major source of particulates and microbial load. When brought…

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Use Disinfectant Rotation Schedules as Per GMP SOPs

June 11, 2025 digi

Use Disinfectant Rotation Schedules as Per GMP SOPs Rotate Disinfectants According to SOP to Prevent Microbial Resistance Remember: Disinfectants must be rotated regularly as per SOP—this is essential to prevent resistance and maintain cleanroom hygiene. Why This Matters in GMP Repeated use of a single disinfectant can lead to microbial adaptation, reducing its efficacy over…

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