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A pharmaceutical process should be managed according to a
series of quality assurance measures to facilitate the
meeting of regulation
quality requirements, and these measures are not all time
under the unique responsibility of Quality Assurance
personnel.
K2ShareHouse module for Process Quality Management is the
only one software that fully covers the new standard for
Pharmaceutical Quality Systems defined by International
Conference for Harmonization (ICH Q10, Pharmaceutical
Quality System guideline): this standard
basically requires that Process should be at the center of
interest, in other terms you have to assure the quality of
your process, not just the quality of your procedures… and
this also means that you need a full knowledge and criticality
analysis of your process, sharing the responsibilities with
many colleagues belonging to different company departments.
Easy to say, but how to do it?
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Mapping the process relevant components...
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Drug Properties
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Unit Operations
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Parameters (range & control method)
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Criticalities
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Process Streams
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Equipments
o
Procedures
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Lab analysis
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Mapping and tracing the process through the product life cycle...
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R&D, Pilot & Industrial Production
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Managing the Technology Transfers...
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Scale up, scale down, etc.
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Taking decisions about Change Control and Corrective/Preventive
Action (CAPA), in order to have a clear
picture of process status and associated criticalities (see also
Change Control
and
CAPA
module)
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