Collection: All Publications
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21 CFR 11, 110, 117, 120 - Food GMPs
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21 CFR 108, 110, 113, 114 and 117 - GMPs for Low-Acid Foods
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GLP Manufacturing Handbook - 4.5x7.5
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FDA DEA GMP Master Reference Guide
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21 CFR 11, 210/211, 820 and ICHQ7 with Audit Checklists - GMP Auditor’s Basic Handbook
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Good Clinical Practice – Medical Device
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21 CFR Part 11 with Scope & Application
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21 CFR Parts 600, 601 610 Biologic GMP
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21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug"
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21 CFR 11, 110, 111 and 117 - Food and Dietary Supplement GMPs
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US, Canada GMPs, ICH Q7, Q8, Q9 & Q10
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21 CFR 210/211 with Keyword Index
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21 CFR 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products
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21 CFR Part 822 - Postmarket Surveillance
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US FDA, Canadian and European MDR
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GCLP Good Clinical Laboratory Handbook - 4.5x7.5
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21 CFR 11, 58, 210/211, 820 - Master GMP Trainer
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21 CFR 11, 210/211 - Electronic Records with Drug GMPs
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21 CFR 101, 110 and 117 - Food Labeling Combination
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21 CFR Part 4 Combination Products with 820
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US & EU GMP Regulations with Annex 1 & ICH Q7
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EU and US GMPs with Q7 API
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EU GMPs with Annex 11, 15 - Computerized Systems and Validation
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21 CFR 4 - Regulation of Combination Products
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