Dietary Supplement GMP is a one-stop how-to road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products.The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances- leaving implementation to the discretion of each firm. Given this latitude and flexibility, this new resource is an essential source of workable and practical suggestions on ways the industry can best meet the goals. Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, it is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory.
Rezensionen / Stimmen
"This book may therefore become a useful tool to further the implementation of more "modern" approaches towards product safety and quality and to actually help transitioning dietary supplements to become food also in real life and not only from a regulatory stand point."
-Elena Vittadini, International Journal of Food Science and Nutrition
"Bill Mead's primer Dietary Supplement Good Manufacturing Practices - Preparing for Compliance, should be required reading for every quality control department in the supplement industry. The book dissects and digests the FDA's lengthy regulations and preamble, making the minutiae of a very complicated rulemaking understandable so the requirements can actually be implemented. Bill Mead offers not only "what" the rule requires but "how" to comply, and "why" each topic is critical to pass your next inspection. Conscientious firms will want to read cover to cover before the FDA inspector knocks on the door."
-Steve Mister, President & CEO, Council for Responsible Nutrition
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für Beruf und Forschung
Scientists involved in development, manufacturing, QC/QA, and testing of dietary supplement products, regulatory affairs professionals in DS industry and pharmaceutical science auditors, contract manufacturers, independent laboratories, and vendors of raw materials and components to the dietary supplement industry.
Illustrationen
10 s/w Photographien bzw. Rasterbilder, 7 s/w Zeichnungen
10 halftones and 7 line drawings
ISBN-13
978-1-4200-7741-4 (9781420077414)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
The Basics of Good Manufacturing Practice. Regulatory Overview. Personnel Matters. Physical Plant and Grounds. Equipment and Utensils. Cleaning and Sanitation. Maintenance and GMP. Calibration. Production and Process Controls. Specifications. Sampling. Deviations and Corrective Actions. Incoming Components, Packaging Materials and Labels. Master Manufacturing Record. Batch Production Record. Manufacturing Operations. Packaging and Labeling Operations. Quality Control Responsibilities. Laboratory Operations. Returned Goods. Product Complaint Handling. Holding and Distributing. Handling Recalls. Top Management Responsibility. Record Keeping, Documentation, SOPs. Change Control. Adverse Event Reporting and Records Keeping. Continuous Improvement. Supply Chain Integrity. Audits. Outsourcing. The FDA. FDA Inspections.
