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Author: Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products Publisher: ISBN: Category : Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products Languages : en Pages : 98
Author: Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products Publisher: ISBN: Category : Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products Languages : en Pages : 98
Author: Phillip A. Carson Publisher: Royal Society of Chemistry ISBN: 0854048340 Category : Science Languages : en Pages : 657
Book Description
Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
Author: Kim Huynh-Ba Publisher: John Wiley & Sons ISBN: 1119120918 Category : Science Languages : en Pages : 420
Book Description
Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.
Author: Philip Carson Publisher: Royal Society of Chemistry ISBN: 1847557724 Category : Science Languages : en Pages : 657
Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Author: Joseph D. Nally Publisher: CRC Press ISBN: 1420020935 Category : Medical Languages : en Pages : 418
Book Description
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Author: R. D. McDowall Publisher: Royal Society of Chemistry ISBN: 178801281X Category : Computers Languages : en Pages : 660
Book Description
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Author: Adrian Gee Publisher: Springer Science & Business Media ISBN: 0387895841 Category : Science Languages : en Pages : 258
Book Description
Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.
Author: William J. Mead Publisher: CRC Press ISBN: 1040171451 Category : Medical Languages : en Pages : 261
Book 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 advances-leaving implementati
Author: Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products
Author: Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products
Author: Allen F. Hirsch
Author: Phillip A. Carson
Author: Kim Huynh-Ba
Author: Philip Carson
Author: Joseph D. Nally
Author: R. D. McDowall
Author: 
Author: Adrian Gee
Author: William J. Mead