Discussion Paper to Explore Managing Validation Activities of CMOs
This article was originally published in The Gold Sheet
Pharmaceutical manufacturers need to carefully plot out how they are going to manage the validation activities with their manufacturing partners. Not planning out these activities before the knowledge transfer can raise the ire of FDA.
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The pharmaceutical industry is proposing new approaches for managing validation activities of contract manufacturing organizations and for estimating the number of batches to run during process validation.
FDA’s final process validation guidance clarifies that legacy products, or products that are currently on the market, will be exempt from early stage process validation. The guidance also endorses the use of process analytical technology for monitoring product quality.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”