Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance's, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

'Where are you from?' they say. What they mean is, 'Why is your skin that colour?' 'Why does your hair look like that?' I am from the mountains, The seas and the sky. I am from children of millions of years, A timeline of humanity. I am from this planet And all others. A heartfelt picture book that challenges racism from an exciting new voice that is both a cry of pain and a demonstration of inner strength, which takes us on an intergalactic journey past collapsing stars and glowing nebulae to remind us not of our differences but of our shared humanity.

This work traces the development of the theory of types from its origins in the early 20th century through its various forms until the mid 1950s. Attention is paid to the reception of this theory after the publication of the second edition of Whitehead and Russell's 'Principia Mathematica'. I examine the decline of the theory over four decades, focusing on its modification by logicians such as Ramsey, Carnap, Church, Quine, Godel, and Tarski. Finally, the view of the theory of types as a many-sorted first-order theory is discussed. It is shown that a revival of the ramified theory of types in the 1950s coincided with the consideration of cumulative type hierarchies which substantially altered the form of the theory. The theory was altered even more drastically in its change from a many-sorted theory to a one-sorted theory. This final 'standardization' made it not much different from first-order Zermelo-Fraenkel set-theory. The theory of types, whose developments are traced in this work, therefore lost its prominence as the foundation for mathematics and logic. This historical analysis will be of interest primarily to those working in the History and Philosophy of Mathematics."