Q: I’ve got a question about validating purity according to Section 7 of the EMA Guidelines for Method Validation (effective February 2012). In the Reference Standards section for Ligand Binding Assays (7.1.1.1.), the guideline says, “Macromolecules are heterogeneous and their…
Tag Archive for Certificateof Conformity
Supplier Audits: Are There Any Alternatives?
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Q: We’ve run into an obstacle with our supplier audits. How would you handle suppliers who won’t let you audit their facilities because either you’re not a big enough customer or they say they don’t have the time?A: First of all, remember…
Supplier Certificates of Conformity: Are They Sufficient?
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Q: Is it acceptable to use supplier Certificates of Conformity sent with their products as evidence they were manufactured per specifications? I’m getting questions about products supplied by our OEMs and contract manufacturers. This has been our approach in the past,…