Pharma sops, Production sops, pharmadocsline,
Customer Requirement Review
Convert the Customer Voice into Actionable Specifications by gathering detailed requirements—covering quality, regulatory, packaging, and delivery expectations—through formal channels like QFD or interviews, ensuring all needs are captured upfront.
Evaluate feasibility via cross-functional teams (QA, R&D, Production, Supply Chain), performing gap analysis and change-control assessment to confirm alignment with internal processes, cGMP, and customer timelines .
Finalize and document agreed-upon requirements in a Customer Requirement Review report, then integrate them into CAPA, validation, and annual quality system reviews to ensure traceability, accountability, and ongoing compliance .
Evaluate feasibility via cross-functional teams (QA, R&D, Production, Supply Chain), performing gap analysis and change-control assessment to confirm alignment with internal processes, cGMP, and customer timelines .
Finalize and document agreed-upon requirements in a Customer Requirement Review report, then integrate them into CAPA, validation, and annual quality system reviews to ensure traceability, accountability, and ongoing compliance .
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