Search results for: gmp-compliance-productivity-and-quality

GMP Compliance Productivity and Quality

Author : Vinay Bhatt
File Size : 29.62 MB
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Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.

Promising Pharmaceuticals

Author : Purusotam Basnet
File Size : 27.84 MB
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From the dawn of civilization, humans have been dreaming of happy, healthy and long-life. Our life expectancy is twice longer than 100 years ago. We know more about the diseases. Therefore we have developed new drugs to fight against them. The demand for drugs was so high that we developed Pharma industries. Although Pharma industries took responsibility of producing the needed drugs and gave us a quality of life, misuse of drugs brought further complication. Therefore, discovery, production, distribution, and the phase of administration of patients' quality assurance has to be controlled with a technological procedure and tight regulations to make the system as effective as possible for the benefit of human health. Our book provides selected but vital information on the sources, tools, technologies and regulations regarding the current status of medicine development.

Good Manufacturing Practices for Pharmaceuticals

Author : Joseph D. Nally
File Size : 83.35 MB
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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.

Good Manufacturing Practices for Pharmaceuticals Seventh Edition

Author : Graham P. Bunn
File Size : 72.83 MB
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This 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.

Hygienic Design of Food Factories

Author : John Holah
File Size : 29.53 MB
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Food safety is vital for consumer confidence, and the hygienic design of food processing facilities is central to the manufacture of safe products. Hygienic design of food factories provides an authoritative overview of hygiene control in the design, construction and renovation of food factories. The business case for a new or refurbished food factory, its equipment needs and the impacts on factory design and construction are considered in two introductory chapters. Part one then reviews the implications of hygiene and construction regulation in various countries on food factory design. Retailer requirements are also discussed. Part two describes site selection, factory layout and the associated issue of airflow. Parts three, four and five then address the hygienic design of essential parts of a food factory. These include walls, ceilings, floors, selected utility and process support systems, entry and exit points, storage areas and changing rooms. Lastly part six covers the management of building work and factory inspection when commissioning the plant. With its distinguished editors and international team of contributors, Hygienic design of food factories is an essential reference for managers of food factories, food plant engineers and all those with an academic research interest in the field. An authoritative overview of hygiene control in the design, construction and renovation of food factories Examines the implications of hygiene and construction regulation in various countries on food factory design Describes site selection, factory layout and the associated issue of airflow

Cumulated Index to the Books

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File Size : 26.76 MB
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The Cumulative Book Index

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File Size : 87.4 MB
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American Book Publishing Record

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File Size : 27.20 MB
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Books in Print Supplement

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File Size : 77.29 MB
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Quality Operations Procedures for Pharmaceutical API and Biotechnology

Author : Syed Imtiaz Haider
File Size : 88.12 MB
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To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.