Tag: audit readiness

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 Why This Matters in GMP Using photocopied documents introduces the risk of working with outdated, unauthorized, or modified content.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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Conduct Routine Gown Integrity Checks in GMP Cleanrooms

May 15, 2025 digi

Conduct Routine Gown Integrity Checks in GMP Cleanrooms Perform Routine Gown Integrity Checks in Clean Environments Remember: Cleanroom garments must be regularly checked for damage or wear to prevent microbial or particulate contamination. Why This Matters in GMP Gowning is the first line of defense against contamination in controlled manufacturing environments. Over time, cleanroom gowns—whether…

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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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Never Discard Rejected Materials in General Trash Bins

May 13, 2025 digi

Never Discard Rejected Materials in General Trash Bins Rejected Materials Must Not Be Thrown into General Waste Bins Remember: Discarding rejected materials in general trash is a serious GMP violation—use designated, controlled disposal procedures. Why This Matters in GMP Rejected pharmaceutical materials, whether due to contamination, deviation, or quality failure, must be handled with utmost…

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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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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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Do Not Include Unrelated Documents in GMP Production Records

May 7, 2025 digi

Do Not Include Unrelated Documents in GMP Production Records Keep Production Records Free of Unrelated Documents Remember: Only include relevant, approved documents in GMP production records to preserve clarity and compliance. Why This Matters in GMP GMP documentation must be organized, traceable, and limited to approved content. Inserting unrelated notes, calculations, or non-referenced documents into…

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Conduct Periodic Pest Control Audits in GMP Storage Areas

May 6, 2025 digi

Conduct Periodic Pest Control Audits in GMP Storage Areas Schedule Regular Pest Control Audits in GMP Warehouses Remember: Routine pest control audits are crucial to preventing contamination and ensuring compliance in pharmaceutical storage areas. Why This Matters in GMP Pests pose a significant risk to pharmaceutical products. Rodents, insects, and birds can damage packaging, introduce…

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