{"product_id":"sterile-processing-of-pharmaceutical-products","title":"Sterile Processing of Pharmaceutical Products","description":"\u003cp\u003e\u003cb\u003eDescribes the methodologies and best practices of the sterile manufacture of drug products\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eThoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. \u003c\/p\u003e\u003cp\u003e\u003ci\u003eSterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments \u003c\/i\u003eprovides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistical procedure. Offering authoritative guidance on the key aspects of sterile manufacturing engineering, this volume: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eCovers fundamentals of aseptic techniques, quality by design, risk assessment and management, and operational requirements\u003c\/li\u003e\n\u003cli\u003eAddresses various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH\u003c\/li\u003e\n\u003cli\u003eProvides techniques for systematic process optimization and good manufacturing practice \u003c\/li\u003e\n\u003cli\u003eEmphasizes the importance of attention to detail in process development and validation\u003c\/li\u003e\n\u003cli\u003eFeatures real-world examples highlighting different aspects of drug manufacturing \u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003ci\u003eSterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments\u003c\/i\u003e is an indispensable reference and guide for all chemists, chemical engineers, pharmaceutical professionals and engineers, and other professionals working in pharmaceutical sciences and manufacturing.\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Product","offer_id":54219671896408,"sku":"9781119802327","price":164.86,"currency_code":"EUR","in_stock":true}],"url":"https:\/\/agendabookshop.com\/products\/sterile-processing-of-pharmaceutical-products","provider":"Agenda Bookshop","version":"1.0","type":"link"}