Tag: data integrity

Update GMP Training Records After Every Training Session

May 17, 2025 digi

Update GMP Training Records After Every Training Session Always Update Training Records Immediately After GMP Sessions Remember: GMP training records must be filled out, signed, and filed after each session—this is critical for compliance and personnel qualification. Why This Matters in GMP Personnel training is a cornerstone of GMP compliance. Accurate and up-to-date training records…

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Never Use Photocopies as Originals for GMP Quality Documents

May 17, 2025 digi

Never Use Photocopies as Originals for GMP Quality Documents Do Not Use Photocopies as Original GMP Quality Documents Remember: Only approved, controlled originals should be used for GMP activities—photocopies are not acceptable as quality documents. Why This Matters in GMP Using photocopied documents introduces the risk of working with outdated, unauthorized, or modified content. Without…

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Review Equipment Logbooks for Completeness During GMP Audits

May 15, 2025 digi

Review Equipment Logbooks for Completeness During GMP Audits Ensure Equipment Logbooks Are Complete Before Every Audit Remember: Incomplete or inconsistent logbooks can jeopardize audit outcomes—always verify records are complete and current. Why This Matters in GMP Equipment logbooks document the history of usage, cleaning, calibration, and maintenance for every critical asset in a GMP facility….

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Never Rely on Memory to Record GMP Observations or Results

May 14, 2025 digi

Never Rely on Memory to Record GMP Observations or Results Document Observations Immediately—Don’t Rely on Memory Remember: All GMP observations and results must be recorded contemporaneously—memory is not a valid data source. Why This Matters in GMP In GMP environments, every observation, measurement, or deviation must be documented at the time it occurs. Delayed entries…

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Calibrate Laboratory Balances Regularly Using Certified Weights

May 12, 2025 digi

Calibrate Laboratory Balances Regularly Using Certified Weights Always Calibrate Laboratory Balances with Certified Weights Remember: All lab balances must be calibrated using certified weights to ensure measurement accuracy and GMP compliance. Why This Matters in GMP Balances are among the most critical instruments in a pharmaceutical laboratory. They are used for weighing reference standards, samples,…

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Do Not Record Test Results Before Completing the Analysis

May 11, 2025 digi

Do Not Record Test Results Before Completing the Analysis Record Test Results Only After Full Completion of Analysis Remember: Entering test results before completing the entire analysis violates data integrity and can mislead quality decisions. Why This Matters in GMP Premature documentation of test results is a critical GMP violation. Such entries misrepresent the actual…

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Verify Reagent Expiry Dates Before Use in QC Laboratories

May 11, 2025 digi

Verify Reagent Expiry Dates Before Use in QC Laboratories Check Reagent Expiry Dates Before Use in QC Testing Remember: Never use reagents in QC labs without verifying their expiry dates — expired reagents compromise test accuracy and compliance. Why This Matters in GMP Reagents play a critical role in analytical testing and product release decisions….

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Maintain Access Logs for Electronic GMP Systems to Ensure Accountability

May 10, 2025 digi

Maintain Access Logs for Electronic GMP Systems to Ensure Accountability Keep Detailed Access Logs for Electronic GMP Systems Remember: Every login, action, or change in GMP electronic systems must be logged and traceable to ensure accountability. Why This Matters in GMP Electronic systems are integral to data collection, analysis, and product release decisions in pharmaceutical…

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Avoid Manual Data Corrections Without Proper Justification

May 9, 2025 digi

Avoid Manual Data Corrections Without Proper Justification Never Perform Manual Data Corrections Without Justification Remember: All corrections to GMP data must be explained, signed, dated, and reviewed — never make undocumented changes. Why This Matters in GMP In regulated environments, every data entry is subject to traceability and verification. Manual corrections without justification raise serious…

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Never Replace Approved SOPs with Verbal Instructions in GMP

May 8, 2025 digi

Never Replace Approved SOPs with Verbal Instructions in GMP Follow Approved SOPs—Never Use Verbal Instructions in GMP Remember: Verbal instructions must not replace approved SOPs in any GMP-regulated activity. Why This Matters in GMP Standard Operating Procedures (SOPs) are the backbone of GMP compliance. They ensure consistency, reproducibility, and control across all operations. When personnel…

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