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| Guidance on Process Validation |
| 01/25/2011 |
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Federal Register Notice: FDA is making available a guidance for industry, Process Validation: General Principles and Practices. It provides information for the pharmaceutical industry on the elements of process validation for manufacturing human and animal drug and biological products, including active pharmaceutical ingredients (APIs). This document revises and replaces the guidance for industry entitled Guideline on General Principles of Process Validation. To download this guidance, click here. To view this notice, click here. |
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Any copying or electronic transfer without written permission is strictly prohibited and will result
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