vbid/9783030024727

Description

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.Typham this is the title: Solid Oral Dose Process Validation The Basics, Volume 1