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General Information
Facility Name
Location
Date of Audit
Auditor Name
Raw Material Receiving
Are raw materials received as per specifications?
Are raw materials stored in a designated area?
Are storage conditions maintained as per requirements?
Are raw material samples tested before use?
Is the raw material inventory managed effectively?
Production Area
Is the production area well-organized and clean?
Are production equipment and machinery in good working condition?
Are production process parameters monitored and controlled?
Are production yields as per expected standards?
Are all production records maintained accurately?
Product Testing
Are in-process tests conducted at defined intervals?
Are final product tests conducted as per specifications?
Are test results documented and reviewed?
Are test methods validated and calibrated?
Are out-of-specification products handled appropriately?
Packaging and Labeling
Are packaging materials stored and handled properly?
Are product labels accurate and compliant?
Is the packaging process well-controlled?
Is the finished product storage area well-maintained?
Are batch records maintained for packaging and labeling?
Waste and Environmental Management
Are waste disposal methods environmentally compliant?
Are waste storage and handling protocols in place?
Are emissions and discharges monitored and controlled?
Are employees trained on waste management practices?
Are corrective actions taken for environmental deviations?