Sarah Breen, Senior Quality Manager at C2 PHARMA, shares her thoughts on supplier oversight with Susan Haigney from Pharmaceutical Technology
Certificates of analysis (CoAs) are used by materials suppliers to identify the product they are providing to a pharmaceutical manufacturer. They include information such as product name, material grade, batch number, expiration dates, testing dates, information on analytical testing performed on the material, as well as additional product information. Pharmaceutical Technology spoke with industry experts about the importance of CoAs and best practices for writing and working with these important documents.
Breen (C2 PHARMA): A standard operating procedure must be in place to document the creation, review, and approval of certificates of analysis. The [SOP] must detail the level of review that is performed on the CoA. Adequate control must be in place to ensure that the possibility of an incorrect CoA being released are kept to a minimum. For example including several level of review both within and between departments for CoA creation, review, and approval. Employers should champion quality culture making employees take quality focused actions.
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