Warren Charlton

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Warren Charlton is a consultant at WHC Bio Pharma Technical Services, PO Box 20309, Greenville, NC 27858, tel. 252.327.4733, fax 252.756.4733.

Articles

Applying Quality by Design to Sterile Manufacturing Processes

Warren Charlton

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.

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