The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry:Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline



This guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products.

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GMP Conferences by Topics

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