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Pharmaceutical Vendors Approval Manual
  • Language: en
  • Pages: 110

Pharmaceutical Vendors Approval Manual

  • Type: Book
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  • Published: 2021-12-12
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  • Publisher: CRC Press

This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simp...

Cleaning Validation Manual
  • Language: en
  • Pages: 610

Cleaning Validation Manual

  • Type: Book
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  • Published: 2010-05-24
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  • Publisher: CRC Press

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protoco...

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology
  • Language: en
  • Pages: 586

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

  • Type: Book
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  • Published: 2012-06-06
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  • Publisher: CRC Press

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 as...

Basics of Pharmaceutical Manufacturing and Quality Operations
  • Language: en
  • Pages: 267

Basics of Pharmaceutical Manufacturing and Quality Operations

  • Type: Book
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  • Published: 2024-03-14
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  • Publisher: CRC Press

This book provides guidance on how to meet the requirements of the pharmaceutical industry as a beginner. It includes procedures for production and packaging, batch auditing as well as all quality measures used in the pharmaceutical industry. This book also provides questions and answers with each chapter for institutes and trainers providing basic training to the new graduates and new comers to the industry. Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide is primarily written for anyone in the pharmaceutical industry interested in development and manufacturing of active pharmaceutical ingredient (API) and finished pharmaceutical manufacturers in both ste...

Quality Control Training Manual
  • Language: en
  • Pages: 486

Quality Control Training Manual

  • Type: Book
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  • Published: 2016-04-19
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  • Publisher: CRC Press

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines dire...

Biotechnology
  • Language: en
  • Pages: 870

Biotechnology

  • Type: Book
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  • Published: 2009-04-13
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  • Publisher: CRC Press

All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry provides ready-to-implement training templates that save time and expense without cutting corners on critical elements. Downloadable Resources: Why Reinvent the Wheel? This complete, single-source reference contains 28 complete biotechnology courses and a customizable downloadable resources with hands-on training tools. The book also pr...

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology
  • Language: en
  • Pages: 580

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

  • Type: Book
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  • Published: 2012-06-06
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  • Publisher: CRC Press

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-

Self Portrait in Green
  • Language: en
  • Pages: 81

Self Portrait in Green

  • Type: Book
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  • Published: 2021-02-25
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  • Publisher: Influx Press

'NDiaye is a hypnotic storyteller with an unflinching understanding of the rock-bottom reality of most people's life.' New York Times ' One of France's most exciting prose stylists.' The Guardian. Obsessed by her encounters with the mysterious green women, and haunted by the Garonne River, a nameless narrator seeks them out in La Roele, Paris, Marseille, and Ouagadougou. Each encounter reveals different aspects of the women; real or imagined, dead or alive, seductive or suicidal, driving the narrator deeper into her obsession, in this unsettling exploration of identity, memory and paranoia. Self Portrait in Green is the multi-prize winning, Marie NDiaye's brilliant subversion of the memoir. Written in diary entries, with lyrical prose and dreamlike imagery, we start with and return to the river, which mirrors the narrative by posing more questions than it answers.

Good Pharmaceutical Manufacturing Practice
  • Language: en
  • Pages: 520

Good Pharmaceutical Manufacturing Practice

  • Type: Book
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  • Published: 2019-08-30
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  • Publisher: CRC Press

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical...

Killing the Water
  • Language: en
  • Pages: 211

Killing the Water

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