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Manufacturing Process Qualification & Validation

Naren Patel1 Manufacturing Process Qualification & ValidationNaren PatelNaren Patel2 Manufacturing Process Qualification & ValidationTutorial Why to Validate What to ValidateProgram How to Perform successful ValidationNaren Patel3 Regulatory 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 Patel4 Purpose 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 Patel5 QSR 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.

Validation Design Validation 21 CFR Sec 820.30 (g) Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production lots or batches, or their equivalents. Design Validation shall ensure that devices conform

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