Dietary supplement good manufacturing practices
Subtitle: preparing for compliance
By: William J. Mead
Publisher: Informa Healthcare
Published: 2011
Place of publication: New York
Language: eng
ISBN-13: 9781420077407
Subjects: Dietary supplements industry; Dietary supplements; MEDICAL / Pharmacy; MEDICAL / Pharmacology; Manufacturing processes; Standards
Description: "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 advancesleaving 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.Dietary Supplement GMP provides:a practical guide in easy to understand language to help navigate through the requirements for systems covering process and quality controlsuggestions and practical recommendations on "how-to" achieve full complianceexplanation of the FDAs role regarding inspection, enforcement, recall/seizure of products and prosecutionDietary Supplement Good Manufacturing Practices (GMP) covers:PersonnelPlants and Grounds Equipment and UtensilsSanitation of Buildings and EquipmentQuality Assurance and Laboratory OperationsThe Quality Control UnitProduction and Process Controls"--
Notes: Includes bibliographical references and index.