Resource Guides

	Code of Federal Regulation Handbooks Our CFR handbook guides contain the minimum current Good Manufacturing Practices (cGMPs) for life science professionals, and help provide a framework for your quality management system. (Select a handbook) 21 CFR 820 – Quality System Regulations 21 CFR 210-211 – Drug GMPs 21 CFR 111 – Dietary Supplements 21 CFR 606 – Blood Industry
	ICH Handbook Our ICH handbook guides help provide a framework for the production, risk and quality systems management of pharmaceutical products. (Select a handbook) ICH Q9 – Risk Management ICH Q10 – Quality Systems
	FDA Inspection Guides FDA Inspection Guides provide guidance on the inspectional process used to assess various life science manufacturer's compliance with quality system regulations. (Select a manual) QSIT for Medical Device Biotechnology Inspection Guide Electromagnetic Compatibility Aspects of Medical Device Quality Systems Bioresearch Monitoring Inspections of In Vitro Diagnostics Devices Mammography Quality Standards Act Auditor's Guide Medical Device Manufacturers High Purity Water Systems Lyophilization of Parenterals Microbiological Pharmaceutical Quality Control Labs Pharmaceutical Quality Control Labs Validation of Cleaning Processes Dosage Form Drug Manufacturers cGMPs Oral Solid Dosage Forms Pre/Post Approval Issues Sterile Drug Substance Manufacturers Topical Drug Products Oral Solutions and Suspensions
	Compliance Map The PathWise Compliance Map is an electronic, Excel-based tool which provides in depth alignment of all worldwide quality system regulations. It contains an easy-to-access view of the regulation scope, terms and definitions, document control, general requirements, management responsibilities and commitment and applicable quality policies. Countries outlined include the United States, Europe, Canada and Japan. (Select a product) Compliance Map
	Comparison Chart: 21 CFR 820 vs ISO 13485 Learn the key differences between 21 CFR 820 and ISO 13485 in this full 54 page comparison table. Contains a detailed side by side comparison of key differentiators between the two quality system standards. (Select a product) Comparison Chart

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