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Manufacturing Process Qualification & Validation

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Naren Patel1Manufacturing Process Qualification & ValidationNaren PatelNaren Patel2Manufacturing Process Qualification & ValidationTutorial Why to Validate What to ValidateProgram How to Perform successful ValidationNaren Patel3Regulatory Requirements Required by ISO 13485 FDA QSR Subpart 820. 75 The Global Harmonization Task Force (GHTF/SG3/N99-10:2004) Quality Management Systems Process Validation Guidance Makes good business senseNaren Patel4Purpose of GHTF Guidance Document To assist manufacturers in understanding quality management system requirements for Process Validation . General applicability to Manufacturing (including servicing and Installation) Process for medical Patel5QSR Process Validation Where the results of a Process cannot be fully verified by subsequent inspection and test, the Process shall be validated with a high degree of assurance and approved according to established procedures.

Naren Patel 3 Regulatory Requirements Required by ISO 13485 –7.5.2 FDA QSR Subpart 820. 75 The Global Harmonization Task Force (GHTF/SG3/N99-10:2004)

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