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This guidance does not address specific method validation recommendations for biological and immunochemical assays for characterization and quality control of many drug substances and drug products....
Question 14: Should cleaning validation be part of a development programme?...
ICH guidance for industry Q2(R1) Validation of Analytical Procedures: Text and Methodology and FDA guidance for industry Analytical Procedures and Methods Validation for Drugs and Biologics provide recommendations...
ICH guidance for industry Q2(R1) Validation of Analytical Procedures: Text and Methodology and FDA guidance for industry Analytical Procedures and Methods Validation for Drugs and Biologics provide recommendations...
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