Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

Timely coverage of cleaning validation for the phamaceutical industry, a dynamic area in terms of health-based limits. Author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and risk-based approaches to cleaning validation. Draws on the author's vast experience in the field of cleaning validation and hazardous materials Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities Diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

Indebtedness, like inequality, has become a ubiquitous condition in the United States. Yet few have probed American cities' dependence on municipal debt or how the terms of municipal finance structure racial privileges, entrench spatial neglect, elide democratic input, and distribute wealth and power. In this passionate and deeply researched book, Destin Jenkins shows in vivid detail how, beyond the borrowing decisions of American cities and beneath their quotidian infrastructure, there lurks a world of politics and finance that is rarely seen, let alone understood. Focusing on San Francisco, The Bonds of Inequality offers a singular view of the postwar city, one where the dynamics that drove its creation encompassed not only local politicians but also banks, credit rating firms, insurance companies, and the national municipal bond market. Moving between the local and the national, The Bonds of Inequality uncovers how racial inequalities in San Francisco were intrinsically tied to municipal finance arrangements and how these arrangements were central in determining the distribution of resources in the city. By homing in on financing and its imperatives, Jenkins boldly rewrites the history of modern American cities, revealing the hidden strings that bind debt and power, race and inequity, democracy and capitalism.

The relationship between race and capitalism is one of the most enduring and controversial historical debates. The concept of racial capitalism offers a way out of this impasse. Racial capitalism is not simply a permutation, phase, or stage in the larger history of capitalism—since the beginning of the Atlantic slave trade and the colonization of the Americas, capitalism, in both material and ideological senses, has been racial, deriving social and economic value from racial classification and stratification. Although Cedric J. Robinson popularized the term, racial capitalism has remained undertheorized for nearly four decades. Histories of Racial Capitalism brings together for the first time distinguished and rising scholars to consider the utility of the concept across historical settings. These scholars offer dynamic accounts of the relationship between social relations of exploitation and the racial terms through which they were organized, justified, and contested. Deploying an eclectic array of methods, their works range from indigenous mortgage foreclosures to the legacies of Atlantic-world maroons, from imperial expansion in the continental United States and beyond to the racial politics of municipal debt in the New South, from the ethical complexities of Latinx banking to the postcolonial dilemmas of extraction in the Caribbean. Throughout, the contributors consider and challenge how some claims about the history and nature of capitalism are universalized while others remain marginalized. By theorizing and testing the concept of racial capitalism in different historical circumstances, this book shows its analytical and political power for today’s scholars and activists.