Tag: Schedule M

Do Not Store Chemicals Without Material Safety Data Sheets (MSDS)

May 21, 2025 digi

Do Not Store Chemicals Without Material Safety Data Sheets (MSDS) Never Store Chemicals Without Their MSDS Documents Remember: Every chemical in the facility must have a readily accessible MSDS to ensure safe handling and regulatory compliance. Why This Matters in GMP Material Safety Data Sheets (MSDS) are essential documents that provide information on the hazards,…

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Perform Visual Inspection of Vials Using Qualified Lighting Conditions

May 20, 2025 digi

Perform Visual Inspection of Vials Using Qualified Lighting Conditions Visually Inspect Vials Under Qualified Lighting Before Release Remember: Every vial must be inspected under standardized lighting to detect defects and comply with GMP sterile product requirements. Why This Matters in GMP Visual inspection is a critical quality control step in sterile manufacturing, especially for injectable…

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Never Touch Sterile Surfaces Without Wearing Gloves

May 20, 2025 digi

Never Touch Sterile Surfaces Without Wearing Gloves Never Touch Sterile Surfaces with Bare Hands Remember: Gloves must be worn and sanitized before touching any sterile surface—direct hand contact is a major GMP violation. Why This Matters in GMP Sterile surfaces are critical points of potential contamination in aseptic processing. Touching them with ungloved or improperly…

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Validate Software Used in GMP Data Acquisition Systems

May 19, 2025 digi

Validate Software Used in GMP Data Acquisition Systems Always Validate Software Used for Data Acquisition in GMP Remember: Any software system used for capturing GMP data must be validated to ensure accuracy, reliability, and regulatory compliance. Why This Matters in GMP In modern pharmaceutical manufacturing, electronic systems are commonly used to acquire, store, and report…

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Do Not Store Clean and Dirty Garments Together in GMP Facilities

May 19, 2025 digi

Do Not Store Clean and Dirty Garments Together in GMP Facilities Never Store Clean and Used Garments Together in GMP Areas Remember: Dirty garments must be segregated from clean ones to prevent cross-contamination and maintain sterile hygiene in cleanroom zones. Why This Matters in GMP Gowning practices are critical to preventing microbial and particulate contamination…

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Monitor Utility Systems Like Water and Compressed Air for GMP Quality

May 18, 2025 digi

Monitor Utility Systems Like Water and Compressed Air for GMP Quality Monitor Water and Compressed Air Systems to Ensure Quality Remember: Critical utilities like water and compressed air must be regularly tested to meet GMP quality standards and ensure product safety. Why This Matters in GMP Water systems and compressed air lines are direct or…

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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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