{"product_id":"gmp-gcp-and-glp-bundle-9781041323402","title":"GMP, GCP and GLP Bundle","description":"\u003cp\u003e • Author(s): Bunn Graham P.\u003cbr\u003e • Publisher: Taylor \u0026amp; Francis\u003cbr\u003e • Publisher Imprint: Taylor \u0026amp; Francis\u003cbr\u003e • BISAC: Industries - General\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis bundle brings together three essential books on the USA regulatory requirements for the discovery\/development, clinical determination and production\/testing of pharmaceutical products: Good Laboratory Practice for Nonclinical Studies, Good Clinical Practices in Pharmaceuticals, and the new eighth edition of Good Manufacturing Practices for Pharmaceuticals. It is a valuable resource for those with responsibilities for complying with the USA Code of Federal (CFR) regulatory requirements for good laboratory, clinical, and manufacturing practices for clinical trial and marketed pharmaceuticals in the United States.\u003c\/p\u003e\u003cp\u003eThe bundle is ideal for start up companies and those that wish to broaden their knowledge and career of this fascinating industry.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eGood Laboratory Practice for Nonclinical Studies\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eThe GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eKey Features: \u003c\/b\u003e\u003c\/p\u003e\u003cul\u003e \u003cli\u003eUnique volume covering FDA inspections of GLP facilities\u003c\/li\u003e \u003cli\u003eProvides a detailed interpretation of GLP Regulations\u003c\/li\u003e \u003cli\u003ePresents the latest on electronic data management in GLP\u003c\/li\u003e \u003cli\u003eDescribes GLP and computer systems validation\u003c\/li\u003e \u003cli\u003eCan be referenced repeatedly in supporting daily hands on implementation of the CFR requirements\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e\u003cb\u003eGood Clinical Practices in Pharmaceuticals\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eGood clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable.Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eKey Features: \u003c\/b\u003e\u003c\/p\u003e\u003cul\u003e \u003cli\u003eProvides the most up-to-date and best practices, techniques, and methodologies in good clinical practice.\u003c\/li\u003e \u003cli\u003eDiscusses applicable laws and regulations supporting GCP compliance, quality and operations.\u003c\/li\u003e \u003cli\u003eDescribes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e\u003cb\u003eGood Manufacturing Practices for Pharmaceuticals, Eighth Edition\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eThis book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eKey Features: \u003c\/b\u003e\u003c\/p\u003e\u003cul\u003e \u003cli\u003ePresents insight into the world of pharmaceutical quality systems.\u003c\/li\u003e \u003cli\u003eAnalyzes regulatory trends and expectations.\u003c\/li\u003e \u003cli\u003eIncludes approaches and practices used in the industry to comply with regulatory requirements.\u003c\/li\u003e \u003cli\u003eDiscusses recent worldwide supply chain issues.\u003c\/li\u003e \u003cli\u003eDelivers valuable information to a worldwide audience regarding the current GMP practices in the industry.\u003c\/li\u003e \u003c\/ul\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Hardcover","offer_id":47961041535127,"sku":"9781041323402","price":47317.0,"currency_code":"INR","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781041323402.webp?v=1782822359","url":"https:\/\/atlanticbooks.com\/products\/gmp-gcp-and-glp-bundle-9781041323402","provider":"Atlantic Books","version":"1.0","type":"link"}