QP Current Practices Challenges and Mysteries_Almac_March2012
QP Current Practices Challenges and Mysteries_Almac_March2012
QP Current Practices Challenges and Mysteries_Almac_March2012
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Continued…What is the Product Specification File?• Responsibility of the Sponsor• A ‘changing’ reference document• May consist of a number of ‘files’ in differentlocations• <strong>QP</strong> MUST have access to any information ifrequired• Assessed by Inspectors