Jorge López Sancho’s Post

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IRCA & CQI GMP PQS Lead Auditor and Quality Assurance Consultant | I help Life Science Companies with Audits, Quality oversight of CMOs and Suppliers, Remediation, GMP Training, Batch Release, CQV | NPI projects 🚀

🔍 FDA guidance on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products 📝 The FDA has issued draft guidance for manufacturers of biosimilar and interchangeable biosimilar products regarding postapproval manufacturing changes. This guidance provides recommendations for holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs), as well as holders of drug master files (DMFs) and veterinary master files (VMFs). If you’re involved in drug substance manufacturing, this information is crucial during the postapproval period. #FDA #biosimilars #manufacturingchanges #pharmaceuticals 👩⚕️🔬

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