Tag: Schedule M

Never Skip Root Cause Analysis During GMP Deviation Investigations

May 27, 2025 digi

Never Skip Root Cause Analysis During GMP Deviation Investigations Root Cause Analysis Is Mandatory in All GMP Deviation Investigations Remember: Every deviation must undergo root cause analysis to implement meaningful corrective and preventive actions (CAPAs). Why This Matters in GMP When deviations occur, simply documenting them is not sufficient—underlying causes must be identified and addressed…

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Validate Cleaning Procedures for Both Dedicated and Shared Equipment

May 26, 2025 digi

Validate Cleaning Procedures for Both Dedicated and Shared Equipment Validate Cleaning Methods for All Equipment—Shared or Dedicated Remember: Cleaning validation is mandatory for all equipment types to prevent contamination and ensure residue removal. Why This Matters in GMP Both dedicated and shared equipment must undergo cleaning validation to demonstrate that residues from previous batches, cleaning…

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Do Not Use Mobile Phones in Sterile Processing Areas

May 26, 2025 digi

Do Not Use Mobile Phones in Sterile Processing Areas Ban Mobile Phone Use in Sterile GMP Processing Areas Remember: Mobile phones are not allowed in sterile environments—they pose contamination, distraction, and data integrity risks in GMP zones. Why This Matters in GMP Sterile processing areas require strict environmental control and operator discipline. Mobile phones, being…

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Install Differential Pressure Gauges in Airlocks to Maintain GMP Zoning

May 25, 2025 digi

Install Differential Pressure Gauges in Airlocks to Maintain GMP Zoning Equip Airlocks with Differential Pressure Gauges for Contamination Control Remember: Differential pressure gauges in airlocks help prevent contamination by maintaining proper airflow direction between cleanroom zones. Why This Matters in GMP In GMP manufacturing, airlocks serve as buffers between areas of different cleanliness classifications. To…

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Do Not Leave Batch Records in Uncontrolled Office Areas

May 25, 2025 digi

Do Not Leave Batch Records in Uncontrolled Office Areas Keep Batch Records Secure—Never Leave Them in Uncontrolled Offices Remember: GMP documentation such as BMRs must be stored in secure, access-controlled locations—not left unattended in uncontrolled environments. Why This Matters in GMP Batch Manufacturing Records (BMRs) are critical GMP documents containing traceable evidence of every stage…

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Implement UV Sterilization Protocols in GMP Change Rooms

May 24, 2025 digi

Implement UV Sterilization Protocols in GMP Change Rooms Use UV Sterilization in Change Rooms to Minimize Contamination Remember: UV light is an effective tool for reducing microbial load in change rooms—incorporate it into cleanroom entry protocols for enhanced GMP hygiene. Why This Matters in GMP Change rooms act as transition zones between non-classified and controlled…

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Do Not Allow Incomplete Documentation During GMP Batch Record Review

May 24, 2025 digi

Do Not Allow Incomplete Documentation During GMP Batch Record Review Do Not Proceed With Batch Review if Documentation Is Incomplete Remember: GMP batch records must be complete in every detail—blank fields or missing data are serious violations and must be corrected before review. Why This Matters in GMP Batch Manufacturing Records (BMRs) document every stage…

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Assign Identification Numbers to All Cleaning Tools for Traceability

May 23, 2025 digi

Assign Identification Numbers to All Cleaning Tools for Traceability Assign Unique IDs to All Cleaning Tools for Traceability Remember: Every mop, brush, or squeegee used in a GMP facility must have a unique ID to ensure traceability and area-specific control. Why This Matters in GMP Cleaning tools, if not properly identified and segregated, can become…

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Never Use Damaged Sieves or Mesh During Granulation in GMP

May 23, 2025 digi

Never Use Damaged Sieves or Mesh During Granulation in GMP Damaged Sieves Must Not Be Used in Granulation Processes Remember: Inspect all sieves and meshes before use—damaged screens compromise granule size, uniformity, and product safety. Why This Matters in GMP Sieves are used during granulation to control particle size distribution and ensure blend uniformity. A…

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Conduct Alarm Challenge Tests to Validate Critical GMP System Responses

May 22, 2025 digi

Conduct Alarm Challenge Tests to Validate Critical GMP System Responses Perform Regular Alarm Challenge Tests on Critical GMP Systems Remember: All critical alarms—HVAC, pressure, temperature—must be challenge-tested to confirm functionality and operator response protocols. Why This Matters in GMP Alarms serve as the first line of defense in detecting and correcting deviations in critical GMP…

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