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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Common Pitfalls• Scope of GMP certification does notcover scope of work performed(e.g. manufacturing line or dosage form)– Inspection report covers Buildings 1,2 <strong>and</strong>3; product manufactured in Building 4– Inspection report covers solid dose- sterileinjectable in the study