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In September, EDQM released a “public document” on using material described in an existing certification of suitability (CEP) in a drug substance for which a separate CEP is requested. EDQM explains that ICH Q11 provides a basis for justification of whether a material covered by the existing CEP is a starting material or an intermediate. The document also elaborates on submission requirements relevant to lifecycle maintenance and transparency of the manufacturing supply chain.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
