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SOLID ORAL DOSE PROCESS VALIDATION IBD

SPRINGER
11 / 2018
9783030024710
Inglés

Sinopsis

Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatoryáguidanceâÇÖs such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidanceâÇÖs 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.áSolid Dose Process Validation: The Basics, Volume Oneáand companionáSolid 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 meetáthe regulatory requirements enlisted in the guidanceâÇÖs, which is the precursor toáapplying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulationsáencompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

PVP
122,00