Tag: WHO GMP

Never Use Handwritten Labels on Released GMP Goods

June 1, 2025 digi

Never Use Handwritten Labels on Released GMP Goods Do Not Use Handwritten Labels on Released Pharmaceutical Goods Remember: GMP prohibits handwritten labeling for released products—printed, validated labels ensure traceability and eliminate confusion. Why This Matters in GMP Labels are essential for product identification, batch traceability, and regulatory compliance. Handwritten labels are prone to legibility issues,…

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Install Insect Traps in Non-Sterile GMP Manufacturing Areas

May 31, 2025 digi

Install Insect Traps in Non-Sterile GMP Manufacturing Areas Install Insect Traps in Non-Sterile Manufacturing Areas Remember: Insect traps help detect and prevent pest ingress in production environments—GMP requires pest control even in non-sterile zones. Why This Matters in GMP Insects and other pests pose contamination risks to pharmaceutical materials and equipment, especially in non-sterile manufacturing…

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Never Apply Pressure to HEPA Filters During Cleaning in GMP Facilities

May 31, 2025 digi

Never Apply Pressure to HEPA Filters During Cleaning in GMP Facilities Never Apply Pressure to HEPA Filters During Cleaning Activities Remember: Applying pressure or physical contact with HEPA filters damages them and undermines GMP cleanroom contamination control. Why This Matters in GMP HEPA filters are critical in maintaining cleanroom classifications by removing 99.97% of particles…

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Document Operator Training for Each Product Line to Ensure GMP Compliance

May 30, 2025 digi

Document Operator Training for Each Product Line to Ensure GMP Compliance Ensure Operator Training Is Documented for Every Product Line Remember: Operators must receive and document training for each product line they handle—GMP requires traceable qualification for specific duties. Why This Matters in GMP Pharmaceutical manufacturing involves varying equipment, procedures, risks, and critical controls across…

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Never Sign Blank Fields in Controlled GMP Documents

May 30, 2025 digi

Never Sign Blank Fields in Controlled GMP Documents Signing Blank Fields in GMP Documents Is a Major Violation Remember: GMP documents must never be signed if data fields are blank—doing so risks falsification and breaches data integrity standards. Why This Matters in GMP Controlled documents like batch records, logbooks, and quality forms require complete, accurate,…

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Audit Third-Party Suppliers to Ensure Their GMP Compliance

May 29, 2025 digi

Audit Third-Party Suppliers to Ensure Their GMP Compliance Audit All Third-Party Suppliers for GMP Adherence Remember: Never rely solely on documents—physically audit third-party suppliers to ensure full GMP compliance and product quality. Why This Matters in GMP Pharmaceutical companies depend on suppliers for APIs, excipients, packaging, and testing services. Relying on third parties without auditing…

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Never Move Unverified Materials to GMP Dispensing Areas

May 29, 2025 digi

Never Move Unverified Materials to GMP Dispensing Areas Unverified Materials Must Not Enter GMP Dispensing Areas Remember: Only QA-released and verified materials should be moved to dispensing—unverified items are a serious GMP risk. Why This Matters in GMP Dispensing is the first step in manufacturing, where materials are measured for batch production. Introducing unverified or…

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Quarantine Returned Goods with Clear Identification Labels

May 28, 2025 digi

Quarantine Returned Goods with Clear Identification Labels Returned Goods Must Be Quarantined with Proper Labels Remember: Always isolate and clearly label returned goods—this prevents mix-ups and ensures GMP-compliant disposition decisions. Why This Matters in GMP Returned pharmaceutical goods—whether from customers, distributors, or hospitals—pose potential risks due to unknown storage conditions, damage, or expired status. Placing…

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Never Conduct Sampling Without Wearing Clean Area Garments

May 28, 2025 digi

Never Conduct Sampling Without Wearing Clean Area Garments Wear Clean Area Garments While Performing Sampling Remember: Sampling without proper clean area garments introduces contamination—GMP mandates full gowning compliance during all sampling activities. Why This Matters in GMP Sampling is a critical step in verifying the quality of raw materials, intermediates, or finished products. It often…

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Check Raw Material Compatibility with Containers During GMP Storage

May 27, 2025 digi

Check Raw Material Compatibility with Containers During GMP Storage Verify Container Compatibility for All Raw Materials in GMP Storage Remember: Raw materials must be stored only in compatible containers to prevent degradation, contamination, or chemical interaction. Why This Matters in GMP Raw materials can be sensitive to factors such as moisture, light, and chemical reactivity….

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