Tag: WHO GMP

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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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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Never Allow Maintenance Tools in Grade A GMP Cleanrooms

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Never Allow Maintenance Tools in Grade A GMP Cleanrooms Prohibit Maintenance Tools from Entering Grade A Cleanrooms Remember: Only sterile, validated tools are allowed in Grade A areas—unauthorized tools pose contamination risks and violate GMP cleanroom protocols. Why This Matters in GMP Grade A environments, such as laminar airflow cabinets and aseptic filling zones, are…

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Use Only Validated Autoclaves for Sterile Component Preparation

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Use Only Validated Autoclaves for Sterile Component Preparation Only Use Validated Autoclaves for Sterile Manufacturing Processes Remember: Autoclaves must be validated before being used for sterilizing components in GMP sterile operations to ensure consistent and effective microbial inactivation. Why This Matters in GMP Autoclaves are critical equipment used to sterilize components such as glassware, garments,…

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Monitor Supplier Specification Changes to Maintain GMP Compliance

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Monitor Supplier Specification Changes to Maintain GMP Compliance Stay Alert to Specification Changes from Your Suppliers Remember: Suppliers must inform you of any specification changes. GMP requires evaluating and approving updated specs before material use. Why This Matters in GMP Raw materials, excipients, and packaging components are all governed by predefined specifications that ensure compatibility…

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Store Samples with Adequate Overage for Retesting and Stability Studies

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Store Samples with Adequate Overage for Retesting and Stability Studies Retain Adequate Overage When Storing Samples for GMP Compliance Remember: Samples must be stored with sufficient quantity for all potential retesting, investigations, and regulatory queries throughout their shelf life. Why This Matters in GMP Retention samples serve as reference material for retesting, complaint investigation, or…

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Do Not Access QA-Reviewed Records Without Proper Authorization

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Do Not Access QA-Reviewed Records Without Proper Authorization Unauthorized Access to QA-Reviewed Records Is Prohibited in GMP Remember: Once GMP documents are QA-reviewed and archived, they must be accessed only by authorized personnel to protect data integrity. Why This Matters in GMP QA-reviewed records—such as batch manufacturing records (BMRs), deviation reports, or analytical logs—are official…

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Maintain Clear Segregation Between Different Product Families in GMP

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Maintain Clear Segregation Between Different Product Families in GMP Ensure Proper Segregation of Different Product Families in GMP Facilities Remember: Different product families must be physically and procedurally segregated during manufacturing and storage to prevent mix-ups and cross-contamination. Why This Matters in GMP Pharmaceutical facilities often produce multiple product types, such as tablets, injectables, or…

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Never Place Open Materials Near HVAC Exhausts in GMP Zones

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Never Place Open Materials Near HVAC Exhausts in GMP Zones Do Not Store Open Materials Near HVAC Exhaust Outlets Remember: Open containers or materials must never be kept near HVAC exhaust vents in GMP areas due to contamination risks and airflow disturbances. Why This Matters in GMP HVAC exhaust vents in cleanrooms and GMP manufacturing…

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Conduct Media Fills to Validate Aseptic Process Integrity in GMP

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Conduct Media Fills to Validate Aseptic Process Integrity in GMP Perform Media Fills to Validate Aseptic Process Integrity Remember: Media fills simulate actual aseptic operations and are essential for validating the sterility assurance of your manufacturing process. Why This Matters in GMP Media fills, also known as aseptic process simulations, are critical tools in sterile…

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