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GMP Tips

Use Material Transfer Notes (MTNs) When Moving Raw Materials

Posted on May 3, 2025 By digi

Use Material Transfer Notes (MTNs) When Moving Raw Materials Do Not Move Materials Without a Valid Material Transfer Note Remember: Always accompany material movement with an authorized MTN to preserve traceability and control. Why This Matters in GMP Material Transfer Notes (MTNs) serve as vital documents that authorize and document the movement of raw and…

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GMP Tips

Verify Batch Yield Calculations Before Finalizing Manufacturing Records

Posted on May 3, 2025 By digi

Verify Batch Yield Calculations Before Finalizing Manufacturing Records Always Verify Batch Yield Calculations Before BMR Finalization Remember: Confirm all yield values before signing off on the Batch Manufacturing Record (BMR). Why This Matters in GMP Yield reconciliation is a critical component of GMP manufacturing that ensures raw materials are efficiently converted into finished products. Yield…

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GMP Tips

Avoid Operating Equipment Without Completing Logbook Entries

Posted on May 2, 2025 By digi

Avoid Operating Equipment Without Completing Logbook Entries Never Use Equipment Without Properly Completing Its Logbook Remember: Equipment must not be operated unless logbook entries for prior and current usage are accurately recorded. Why This Matters in GMP In GMP-compliant environments, every piece of equipment has its own identity and operational history. Equipment logbooks serve as…

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GMP Tips

Conduct Risk Assessments Before Implementing Process Changes

Posted on May 1, 2025 By digi

Conduct Risk Assessments Before Implementing Process Changes Ensure Risk Assessment Precedes Any Change in Manufacturing Process Remember: Never initiate process changes without first conducting a documented risk assessment. Why This Matters in GMP In the pharmaceutical industry, even minor changes to a manufacturing process can have significant consequences. A change that appears harmless may introduce…

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GMP Tips

Conduct Risk Assessments Before Implementing Process Changes

Posted on May 1, 2025 By digi

Conduct Risk Assessments Before Implementing Process Changes Ensure Risk Assessment Precedes Any Change in Manufacturing Process Remember: Never initiate process changes without first conducting a documented risk assessment. Why This Matters in GMP In the pharmaceutical industry, even minor changes to a manufacturing process can have significant consequences. A change that appears harmless may introduce…

Read More “Conduct Risk Assessments Before Implementing Process Changes” »

GMP Tips

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  • Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas

    Do Not Stockpile Rejected Units… Read more

GMP Tips

  • Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas
  • Update GMP Training Records After Every Training Session
  • Never Use Photocopies as Originals for GMP Quality Documents
  • Verify Integrity of Tamper-Evident Seals During Packaging
  • Never Use Trial Batches for Commercial Release Under GMP
  • Conduct Routine Gown Integrity Checks in GMP Cleanrooms
  • Prohibit Forklift Use in Primary Packaging Areas to Prevent Contamination
  • Review Equipment Logbooks for Completeness During GMP Audits
  • Never Rely on Memory to Record GMP Observations or Results
  • Follow Hold Time Studies to Ensure Product Stability and Safety

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