Shop and download the basic collection of standard operating procedures (SOPs) to ensure your compliance, or your manufacturer's compliance, with the FDA dietary supplement regulations 21 CFR 111 and with food supplement regulations in the European Union and UK, for importing supplements with confidence to these markets
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All Dietary Supplement SOPs and Checklist
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Full GMP Checklist for Dietary Supplements
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1.0 - Dietary Supplement 21 CFR 111 Definitions
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2.0 - Personnel Qualifications and Training
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2.1 - Personnel and Visitor Sickness Policy
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2.2 - Personnel Hygiene and Dress Code
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3.0 - Facility Design and Construction
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3.1 - Yard and Grounds Maintenance
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3.3 - Cleaning & Sanitizing Agents
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4.0 - Equipment Design and Construction
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4.1 - Equipment Calibration of Instruments
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4.2 - Equipment Cleaning and Sanitizing
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4.3 - Equipment Program of Maintenance
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5.0 - Specifications and Process Control
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5.1 - Representative and Reserve Samples
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5.2 - Adjustments and Reprocessing
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6.0 - Quality Control Requirements
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8.0 - Master Manufacturing Record
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10.3 - Laboratory Specifications
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10.4 - Laboratory OOS Investigation & Form
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10.5 - Laboratory Physical and Chemical Testing
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10.6 - Laboratory Microbiology Testing Overview
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10.7 - Laboratory Stability Testing
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10.8 - Laboratory Method Validation
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11.0 - Manufacturing Operations
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12.0 - Packaging and Labelling Operations
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13.0 - Warehouse Holding Requirements
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13.1 - Distribution and Good Distribution Practice (GDP)
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14.0 - Returned Dietary Supplements
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15.0 - Product Complaints Handling
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16.0 - GMP Records for Supplements
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