Tag: FDA 21 CFR Part 211

Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas

May 18, 2025 digi

Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas Rejected Units Must Not Be Stored in Dispensing Areas Remember: Rejected materials should be promptly removed from dispensing areas to prevent mix-ups, cross-contamination, or unauthorized usage. Why This Matters in GMP Dispensing areas are reserved for handling approved materials that meet all quality specifications. Keeping rejected…

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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 Why This Matters in GMP Using photocopied documents introduces the risk of working with outdated, unauthorized, or modified content.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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Verify Integrity of Tamper-Evident Seals During Packaging

May 16, 2025 digi

Verify Integrity of Tamper-Evident Seals During Packaging Check Tamper-Evident Seals for Integrity During Packaging Remember: Tamper-evident seals must be visually verified during packaging to ensure they are applied correctly and uncompromised. Why This Matters in GMP Tamper-evident packaging is a vital mechanism for protecting pharmaceutical products against manipulation and counterfeiting. These seals serve as visible…

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Never Use Trial Batches for Commercial Release Under GMP

May 16, 2025 digi

Never Use Trial Batches for Commercial Release Under GMP Trial Batches Must Never Be Released for Commercial Sale Remember: Trial or test batches are meant for validation, not market release. Only GMP-compliant commercial batches may be distributed. Why This Matters in GMP Trial batches are manufactured during early development, scale-up, or process validation. They are…

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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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Prohibit Forklift Use in Primary Packaging Areas to Prevent Contamination

May 15, 2025 digi

Prohibit Forklift Use in Primary Packaging Areas to Prevent Contamination Forklifts Must Not Be Operated in Primary Packaging Zones Remember: Forklift usage in clean or primary packaging areas violates GMP zoning and increases contamination and safety risks. Why This Matters in GMP Forklifts are designed for warehouse and bulk material movement—not for cleanroom or primary…

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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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Follow Hold Time Studies to Ensure Product Stability and Safety

May 14, 2025 digi

Follow Hold Time Studies to Ensure Product Stability and Safety Always Follow Hold Time Studies to Preserve Product Stability Remember: In-process materials must not exceed validated hold times—doing so risks microbial growth and product degradation. Why This Matters in GMP Hold time studies define how long a product or intermediate can be held between manufacturing…

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