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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
483s and Warning Letters Point to Inadequate Quality Oversight
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.