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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.
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