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This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phase
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This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operat
IT Compliance and Controls offers a structured architectural approach, a 'blueprint in effect,' for new and seasoned executives and business professionals alike to understand the world of compliance?from the perspective of what the problems are, where they come from, and how to position your company to deal with them today and into the future.
Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rule...
As manufacturing and distribution practices get more complex and more global, manufacturers cannot just focus on one or two sets of requirements - it is too difficult to operate a quality system that has a multitude of variations to meet the individual requirements of a particular national authority. Most multinational firms and those supplying global markets have done what national authorities have not - they have created quality systems and quality system elements that internally harmonize GMP expectations. Yes, there still are some unique requirements that need to be met, but having a majority of requirements harmonized reduces duplication and increases flexibility. GMP in Practice, 4th E...
Readers can explore James Bond creator Ian Fleming’s writing on the pleasures of drinking and mix themselves fifty delicious cocktails from recipes inspired by his books and developed by award-winning London bar, Swift. Both Bond and Fleming were partial to a stiff drink. In both fiction and real life, cocktails were an important and well-chosen accompaniment to adventure and daring and often relaxing. Fleming made the Martini famous with Bond’s ritual of always ordering it “shaken, not stirred”. But in every James Bond book a wide selection of strong, sophisticated and carefully crafted drinks are essential details to the story. The recipes in Shaken are divided into five categories...
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.
The release of Skyfall in 2012 marked the fiftieth anniversary of the James Bond film franchise. It earned over one billion dollars in the worldwide box office and won two Academy Awards. Amid popular and critical acclaim, some have questioned the representation of women in the film. From an aging M to the limited role of the Bond Girl and the characterization of Miss Moneypenny as a defunct field agent, Skyfall develops the legacy of Bond at the expense of women. Since Casino Royale (2006) and its sequels Quantum of Solace (2008) and Skyfall constitute a reboot of the franchise, it is time to question whether there is a place for women in the new world of James Bond and what role they will ...